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EC number: 203-253-7
CAS number: 104-93-8
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
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.
No data available.
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.
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