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EC number: 202-607-8
CAS number: 97-77-8
Source, RA-A, CAS 137-26-8, key, Split Adjuvant Test (guinea pig,
OECD 406 and EPA OPP 81 -5, GLP): skin sensitizing
There were no skin reactions observed in the control animals,
except for one animal which showed red spots in reaction in the first
reading after the challenge exposure. This skin reaction was scored with
Test substance group
The test substance, suspended in petrolatum at 25% and administered
epicutaneously to guinea pigs in the challenge phase, resulted in a
positive skin response (grade 2) in 8 animals 24 h after the challenge
phase and 6 animals 48 h after the challenge phase. This corresponds to
a sensitization rate of 40%.
Summarized results can be found in Attachment 1 in the attached
There are no data on sensitisation with disulfiram. Therefore, its
sensitisation potential is assessed using read-across from a study
conducted with the source substance, thiram (CAS 137 -26 -8). (For
detailed information on the justification of read-across, please refer
to the analogue justification document attached in IUCLID section 13).
One reliable animal sensitisation study performed according to
EPA-OPP 81-6 (Split Adjuvant Test) is available for thiram (Report
number 0174/263). A 25% dilution of the substance caused
sensitisation in 8/20 female guinea pigs 24 hours after challenge. No
irritation was observed in the animals. Thus, under the test conditions,
the test substance produced a sensitizing reaction in guinea pigs with a
skin sensitisation rate of 40%. According to the classification criteria
of the CLP Regulation (EU) No. 1272/2008, classification for skin
sensitisation Category 1 (H317) is warranted.
Patch testing in sensitised humans, the pure substance induced a
reaction, while the substance formulated into rubber did not cause any
effects (Crabtree, 1978).
Based on the available data for the read across source substance, the
test item induced skin sensitization in guinea pigs and human
volunteers. Therefore, the source and the target substance is classified
as skin sensitising category 1 (H317) according to Regulation (EC) No
1272/2008 and Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation,
Index No. 006-079-00-8 (target substance)).
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