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EC number: 204-427-5
CAS number: 120-80-9
Two studies are used in a weight of evidence approach.
Catechol never induced an observable sensitivity to less
than 0.2 µmole with a geometric mean of 3.2 µmoles.
a dermal sensitization study (Baer et al., 1967) with Catechol,
8 to 12 Hartley guinea pigs were tested using a modified method of
Freund's complete adjuvant test.
Sensitisation was carried out by injection of an emulsion
in complete Freund's adjuvant, at weekly intervals,
successively into the nuchal area, the inguinal-axillary
region and the foot pads.
Animals were given a skin test (topical application of
catechol in acetone) 4 weeks after the last sensitising
injection and then given two repetitive tests at 2-weeks intervals.
In this study,
Catechol was used as inducer of sensitization and gave the appropriate
response as “sensitizing”.
considered as a skin sensitizer in this study.
2/9 animals showed positive response, that
corresponding at 22% of the animals.
a dermal sensitization study (Rao et al., 1981) with Catechol,
9 adult Hartley guinea pigs were tested using a modified method
of Split adjuvant
Chemical allergen and Freund's
adjuvant are administered separately to the skin rather than as
emulsion. Induction phase was made by 4
topical applications in 10 days. At the third application,
intradermal injection of 0.2 ml FCA was made. Challenge was realised
2 weeks later.
this study, 2 animals on 9 presented positive reaction. It was
considered as not sufficient to classify Catechol as a potential skin
Two Key studies with reliability 2 were available.
In one study (Rao, 1981) the sensitization of catechol was tested by a Split adjuvant test. In the other study (Baer, 1967), Catechol was tested with n-alkylcatechol in a Freund's complete adjuvant test.
In both studies Catechol showed positive response, but Split Adjuvant test indicated a positive response in 22% of the animals that is not sufficient for a classification as sensitizer.
The majority of the animals injected became sensitized lead to the conclusion that Catechol is a potential skin sensitizer.
the available data and according to classification criteria of EC
regulation 1272/2008 the catechol should be self-classified as skin
sensitizer category 1 (H317: May cause an allergic skin reaction). The
available data do not allow the distinction between the subcategories
1A and 1B.
In the 13
th ATP of the CLP Regulation, no harmonised classification is proposed
for this endpoint.
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