Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Non-human information

There are no animal data available for 7PPD. There is ample evidence for multiple similar chemical substances that skin sensitization is a common feature, so sensitiztion was not conducted in the early time periods of REACH, before in vitro tests were available, to avoid needless testing on animals when the lead registrant was comfortable in classifying the substance as a category 1 sensitizer.

Human information

There is limited human information available for 7PPD.

7PPD:

No positive skin reactions were noted in a repeated insult patch test (modified Draize skin test) with human volunteers. The human volunteers were exposed 9 times within 3 weeks to 7PPD, at 1% in petrolatum and after this the patch was applied to a previously unpatched site. The challenge patches were removed 48—72 hours following application. Reactions to the challenge applications were scored at 96 hours following applications.There was no evidence of allergic contact sensitization to 7PPD, at 1% in petrolatum in any of the volunteers evaluated (0/80) (Monsanto Co. 1979).


Justification for classification or non-classification

There is ample evidence for multiple similar chemical substances that skin sensitization is a common feature, so sensitiztion was not conducted in the early time periods of REACH, before in vitro tests were available, to avoid needless testing on animals when the lead registrant was comfortable in classifying the substance as a category 1 sensitizer.