Registration Dossier

Administrative data

Endpoint:
respiratory sensitisation, other
Remarks:
Expert Statement
Type of information:
other: Expert statement
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No study result but rational argumentation also considering structural analogue substances.
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
other: expert statement
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: expert evaluation
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
other: not applicable
Strain:
other: not applicable
Details on test animals and environmental conditions:
not applicable

Test system

Route of induction exposure:
other: not applicable
Route of challenge exposure:
other: not applicable
Vehicle:
other: not applicable
Concentration:
not applicable
No. of animals per dose:
not applicable
Details on study design:
not applicable
Challenge controls:
not applicable

Results and discussion

Results:
Although there is no respective study result for TODI available, for precautionary reasons TODI was classified as a substance that "may cause allergy or asthma symptoms or breathing difficulties if inhaled" as (1) TODI was found as sensitizer in a Magnusson & Kligman maximisation study in the guinea pig and (2) similar substances as e.g. MDI (CAS no. 9016-87-9) and 4,4'-Methylendicyclohexyldiisocyanat (CAS no. 5124-30-1; EC no. 225-863-2) are also labelled with H317 and H334.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Conclusions:
Although there is no respective study result for TODI available, for precautionary reasons TODI was classified as a substance that "may cause allergy or asthma symptoms or breathing difficulties if inhaled" as (1) TODI was found as sensitizer in a Magnusson & Kligman maximisation study in the guinea pig and (2) similar substances as e.g. MDI (CAS no. 9016-87-9) and 4,4'-Methylendicyclohexyldiisocyanat (CAS no. 5124-30-1; EC no. 225-863-2) are also labelled with H317 and H334 due to the isocyanic moiety as a common structural alert. Based on the available data described for similar isocyanates, a potential for respiratory sensitisation is likely for TODI too. Therefore the TODI is expected to be a respiratory sensitiser.
Executive summary:

Although there is no respective study result for TODI available, for precautionary reasons TODI was classified as a substance that "may cause allergy or asthma symptoms or breathing difficulties if inhaled" as (1) TODI was found as sensitizer in a Magnusson & Kligman maximisation study in the guinea pig and (2) similar substances as e.g. MDI (CAS no. 9016-87-9) and 4,4'-Methylendicyclohexyldiisocyanat (CAS no. 5124-30-1; EC no. 225-863-2) are also labelled with H317 and H334 due to the isocyanic moiety as a common structural alert. Based on the available data described for similar isocyanates, a potential for respiratory sensitisation is likely for TODI too. Therefore the TODI is expected to be a respiratory sensitiser.