International Harmonization of Nomenclature and Diagnostic Criteria (INHAND)

Dog
(Toxicologic Pathology 2021; Vol 49(1), 5–109)

Minipig
(Toxicologic Pathology 2021; Vol 49(1), 110–228)

Non-human Primate
(J Toxicol Pathol 2021; 34 (3 Suppl): 1S–182S)

Rabbit
(J Toxicol Pathol 2021; 34 (3 Suppl): 183S–292S)

INHAND: An Overview and Review of Basic Principles
(Supplement to Vol 40, No. 4)

Cardiovascular
(J Toxicol Pathol 2016; 29 (No. 3_Suppl): 1S–47S)

Central and Peripheral Nervous Systems
(Supplement to Vol 40, No. 4)

Endocrine
(J Toxicol Pathol 2018; 31 (3 Suppl): 1S–95S)

Gastrointestinal Tract, Pancreas and Salivary Glands
(J Toxicol Pathol 2016; 29 (1 Suppl): 1S–124S)

Hematolymphoid
(Toxicologic Pathology 2019; Vol 47(6))

Hepatobiliary
(Supplement to Vol 38, No. 7)

Integument
(J Toxicol Pathol 2013; 26 (3 Suppl)

Mammary, Zymbal’s, Preputial, and Clitoral Glands
(Supplement to Vol 40, No. 6)

Reproductive: Female
(J Toxicol Pathol 2014; 27(3–4 Suppl)

Reproductive: Male
(Supplement to Vol 40, No. 6)

Respiratory
(Supplement to Vol 37, No. 7)

Soft Tissue, Skeletal Muscle and Mesothelium
(J Toxicol Pathol 2013; 26 (3 Suppl)

Skeletal (Bones, Joints, and Teeth)
(J Toxicol Pathol 2016; 29 (No. 3_Suppl): 49S–103S)

Special Sense Organs (Ocular, Olfactory, and Otic)
(J Toxicol Pathol 2018; 31 (3 Suppl): 97S–214S)

Urinary
(Supplement to Vol 40, No. 4)

• Overview of Process
• New Term Request Form
• Change of or Addition to Criteria for Published Term Request Form
• Change of Published Term Request Form
• Additional Synonym for Published Term Request Form
• Addition of New Photograph Request Form
• Additional Organ Topography for Published Term Request Form
• Deletion of Term Request Form

INHAND CHANGE CONTROL

INHAND has established five nonrodent working groups (NRWG)—nonhuman primate, dog, mini-pig, rabbit and most recently fish. These groups are following goals and objectives similar to the rodent organ working groups:

• NRWG should evaluate and consider previously available nomenclature resources—appropriate literature as well as published INHAND rodent manuscripts, GoRENI, and SSNDC. (GoRENI at www.goreni.org; SSNDC at www.toxpath.org—click on Publications>SSNDC Guides link)
• Scope of work for each NRWG will include nomenclature for proliferative and nonproliferative lesions for the nonrodent species.
• Spontaneous as well as common induced lesions.
• Seek broad input of the toxicologic pathology community on draft manuscripts.
• Finalize manuscripts and compile into a format suitable for publication.

Standardized nomenclature will be addressed using the principles outlined in the INHAND proposal. In general, the working groups will develop nomenclature that is primarily descriptive in nature and denote findings which can be documented from the review of routine histologic specimens. NRWG will develop a preferred term but also may note previously used terms for each lesion under consideration. As much as possible, additional fields and modifiers should be uniform across organ systems.

While the groups are using the currently published rodent INHAND documents, SSNDC guide (if available) and appropriate literature reference, it is understood that certain species/systems may need terms that are not covered in these documents and these will be addressed. The NRWGs are using a series of tables for each organ system, outlining the diagnoses from previously published INHAND rodent systems. The diagnoses will fall under one of 4 categories: Common, Uncommon, Not Applicable, Not observed/Relevant. If a diagnosis has distinctive morphologic criteria and/or comments appropriate to the species, these will be covered in a brief text. Diagnoses that are unique to the species will have a full outline similar to the format in the rodent publications.

As part of evaluating standardized terminology, the groups have developed a proposal for assessment of skeletal and sexual maturity. Recording an overall assessment of sexually immaturity or maturity has not been standard practice in general nonclinical toxicology studies. Inclusion of this information may be helpful in interpreting risk assessment for juvenile or adult populations and could limit the need for additional studies. Providing comment on the stage of maturity when using (peri)pubertal animals in toxicity studies can be helpful since varying stages of maturity can hamper judgment on possible reproductive effects. The current industry practice is to include specific reproductive end points on a case by case base (Halpern et. al., 2016). The INHAND proposal is currently under review by the SEND Controlled Terminology and Core Teams, to determine if additional data fields will be needed in SEND to accommodate the maturity information.

All nonrodent groups are making steady progress and targeting documents to be ready for membership review later in 2017.

• INHAND Update

Harmonization of nomenclature and diagnostic criteria in toxicologic pathology, especially for rats and mice, has been a goal of pathologists working in the profession for many years. In the latter part of the twentieth century, several initiatives were undertaken by the STP in the United States and by the RITA data base group (Registry of Industrial Toxicology Animal—data) in Europe. Their efforts resulted in a number of internationally recognized publications: SSNDC: Guides for Toxicologic Pathology and the WHO/IARC International Classification of Rodent Tumors.

In 2005, the Strategic and Regulatory Policy Committee (SRPC) decided that the time was ripe for a revision of the earlier guides. Their proposal stated: There is general agreement that the previous SSNDC nomenclature guides should be reviewed and revised if necessary. Some fascicles for non-proliferative lesions were never completed. Broad involvement of European and Japanese scientists will be necessary to ensure worldwide acceptance and endorsement.

The European Society of Toxicologic Pathology, in conjunction with RITA, endorsed the proposal in late 2005. They suggested that since RITA had recently completed a large amount of work on proliferative lesions of both rats and mice, that the project focus on non-proliferative lesions. They also offered to provide an open version of RENI (goRENI: global open Registry Nomenclature Information System (www.goreni.org) to serve as a platform. Access to goRENI is available to all members of the participating STPs (see below for further information on accessing goRENI.)

The result of these discussions was the INHAND Proposal (International Harmonization of Nomenclature and Diagnostic Criteria for Lesions in Rats and Mice ). In 2006, the BSTP and the JSTP joined the initiative, so that the project was truly global.

The GESC (Global Editorial Steering Committee) to oversee the activities of the project. The GESC is composed of toxicologic pathologists from all of the participating societies. In addition there are several technical consultants for web and print support.

The Working Groups (WG) are the core of the project. Each Group is responsible for producing the non-neoplastic nomenclature for their particular organ or species. In addition, they review the proliferative lesions already posted on goRENI and discuss them with the RITA groups so that the final nomenclature, both proliferative and non-proliferative represent the consensus of the international collaborators.

The Chair of each WG is appointed by the GESC. Members of the group come from each of the participating Societies and may be nominated by the Chair or by the individual STPs.

There are active WGs for all organ systems in the rodent. However, INHAND has been expanded to include non-rodent species. If you would like to volunteer to be member of an WG, please indicate your interest by sending an email to stp@toxpath.org.

When a Working Group has completed a draft of its nomenclature, the draft (with illustrations) is submitted to the GESC for initial approval and then posted on goRENI. The membership of each Society is then notified that the draft is posted and available for comments for a 60 day period. After the comment period is completed, the OWG will consider the comments and prepare a final draft. This final draft is reviewed once more by the GESC and posted on goRENI

In addition to goRENI, the completed nomenclature for each organ system or species will be published in the official journals of the participating Societies: Toxicologic Pathology (STP, BSTP, and ESTP), and the Journal of Toxicologic Pathology (JSTP).

• INHAND Proposal
• Global Editorial Steering Committee (GESC) membership
• Working Groups Membership
• goRENI (Global Open Registry Nomenclature Information System)
• How to use goRENI
• SOP on Administration and Operation of INHAND