Registration Dossier

Administrative data

Description of key information

Skin irritation:
In the key study according to the OECD test guideline 404, mean erythema scores (24h, 48h and 72h readings) were found to be 2.7, 3.0 and 2.7 and mean edema scores resulted in 0.3, 1.0 and 0.0 for each respective animal. At the end of the observation period, erythema was still seen in 2of 3 animals and scaling was observed in one animal.
Eye irritation:
In the key study according to the OECD test guideline 405, mean cornea iris and chemosis scores (24h, 48h and 72h readings) were found to be 0, 0.3 and 0 and mean conjunctival redness scores resulted in 0.7, 1.0 and 0.7 for each respective animal. These parameter showed full reversibility.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin irritation:

In the key study according to the OECD test guideline 404, undiluted 4-methylanisole was applied under semiocclusive conditions to skin sites of each of 3 Vienna White rabbits for 4 hours and the skin was examined 30-60 minutes after test substance removal, 24, 48, 72 hours and 8, 15 days after test substance application. Mean erythema scores (24h, 48h and 72h readings) were found to be 2.7, 3.0 and 2.7 and mean edema scores resulted in 0.3, 1.0 and 0.0 for each respective animal. At the end of the observation period, erythema was still seen in 2of 3 animals and scaling was observed in one animal (BASF18H0143/892036).

Further evidences for a dermally irritating potential of 4-methylanisole was given by further studies, being in part reported as secondary references with limited information, i.e. a slight to moderate irritation in an acute dermal toxicity study in rabbits, a moderate irritation observed after dermal semiocclusive application on rabbits for 4 hours, and erythema, desquamation and edema formation together with ulceration and microabscess formation after a daily 6 hour applications for 14 days on rats under semiocclusive conditions.

Eye irritation:

In the key study according to the OECD test guideline 405, undiluted 4-methylanisol was instilled into the conjunctival sac of the right eye of each of 3 rabbits without removal by washing out (BASF11H0143/892037). Animals were scored 1h, 24h, 48h and 72h after test substance application according to Draize. Slight and reversible irritation has been observed in this study according to the Draize scores, although contracted pupils at the end of the observation period were found in 2 of 3 animals. Mean cornea iris and chemosis scores (24h, 48h and 72h readings) were found to be 0, 0.3 and 0 and mean conjunctival redness scores resulted in 0.7, 1.0 and 0.7 for each respective animal.


Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

Based on the key study for skin irritation, the 4-methylanisol fulfils the criteria under 67/548/EEC and regulation (EU) 1272/2008 and is therefore to be classified as irritating to the skin (R38 and Category 2).

 

Based on the key study for eye irritation, the 4-methylanisol does not fulfill the criteria under 67/548/EEC and regulation (EU) 1272/2008 and a non classification is warranted.