Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The test material, (see attached file) was investigated for dermal sensitisation potential utilising a Buehler guinea pig test.

In the induction phase of the exposure, 0.4 mL of the test material was applied at a 15 % w/w concentration in distilled water to the clipped left shoulder of 20 Hartley guinea pigs. The application was done using a Hilltop Chamber secured in an occlusive fashion for 6 hours. Two additional induction doses were conducted following the same procedure, at weekly intervals. 

Two weeks after the final application, the animals received a topical primary challenge dose (6 hour occlusive contact) of the test material at 7.5 % concentration w/w in distilled water on a naive site located on the right shoulder. Animals were scored for irritation at 24 and 48 hours after initiation of the primary challenge application.

Ten guinea pigs served as a naive control group, and remained untreated through the induction phase. Five naive control animals received the primary challenge dose, at a 7.5 % concentration. 

The incidence and severity of the responses in the test animals were not significantly greater than those produced by the naive control group, indicating that sensitisation had not been induced.

Under the conditions of this study, it was determined that the test material did not induce sensitisation in accordance with EU criteria.


Migrated from Short description of key information:
In a Buehler guinea pig test it was determined that the test material did not induce sensitisation.

Justification for selection of skin sensitisation endpoint:
Only one study is available; it was assigned a reliability score of 1 in accordance with the criteria detailed by Klimisch (1997). The key study was conducted in line with GLP and in accordance with the standardised guidelines OECD 406 and EPA OPPTS 870.2600. The test was also PR 86-5 compliant.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation 1272/2008, the test material does not require classification as a skin sensitiser.