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:

In the key study according to OECD TG 429 and GLP, three groups of four female CBA/CaOlaHsd mice were treated with 10, 25 or 50% 4 -methylanisol in methyl ethyl ketone by topical application at the dorsum of each ear on three consecutive days (BASF58H0506/099149). In a former pre-test, ear swelling was observed on day 6 before sacrifice in the animal treated with undiluted test substance and the ear thickness measurement on day 6 showed an ear swelling of approximately 28% in comparison to the measurement on day 1 prior to treatment. In the main study, the animals did not show any signs of systemic toxicity and no cases of mortality were observed. Signs of local irritation (e.g. reddening of the ear skin, ear swelling) were also not observed during the study period. A statistically significant increase in ear weights was not observed in treated animals compared to control group. Stimulation Indices (S.I.) of 1.56, 2.08 and 2.39 were determined with the test item at concentrations of 10, 25 and 50%, respectively. A statistically significant increase in lymph node weights was not observed in treated groups compared to controls. The EC3 value could not be calculated, since none of the tested concentrations induced an S.I. greater than 3. Overall, 4 -methylanisol did not show a skin sensitizing potential under the test conditions of this study.

 

In support, a review, discussing the open epicutaneous test, presented data for about 300 fragrance raw materials in limited tabular form (Klecak 1985). For 4 -methylanisol, no sensitization reaction were reported using this test protocol.

 

A supportive human maximization test on 25 male volunteers is available as short abstract in a database (Kligman1971). After pretreatment with 5% sodium lauryl sulfate, closed patch applications of 2% 4 -methylanisol in petrolatum for five alternate-day 48-hour periods, followed by occlusive challenge application for 48 hours after a 10-day rest period was performed. No effects on these volunteers were reported. 


Migrated from Short description of key information:
Local lymph node assay (according to OECD 429, GLP): negative (BASF58H0506/099149)

Respiratory sensitisation

Endpoint conclusion
Additional information:

No data available.

Justification for classification or non-classification

The present data on dermal sensitization do not fulfill the criteria laid down in 67/548/EEC and regulation (EU) 1272/2008, and therefore, a non-classification is warranted.