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EC number: 231-272-0
CAS number: 7473-98-5
Study conducted to recognised training
guidelines with GLP certification.
Skin effects after intradermal
- Control and test groups:
The expected and common findings were
observed after the different applications using FCA intradermally and
consisted of erythema, oedema, necrotizing dermatitis, encrustation and
exfoliation of encrustation.
Skin effects after epidermal induction:
- Control group:
No erythematous or oedematous reaction was
observed in the animals treated with PEG 400 only.
- Test group:
Discrete/patchy erythema was observed in 5
(at the 24 -hour reading) and 6 (at the 48 -hour reading) out of 10
animals after treatment with the undiluted test article.
Skin effects after the challenge:
No skin reactions were observed in the
animals when treated with either PEG 400 only or when treated with the
test article at 25% in PEG 400.
In this guideline (OECD 406) study
conducted with GLP certification, the test material (EC 231-272-0) did
not induce skin sensitisation in the test animals (Guinea pig). The test
was conducted using the Guinea pig maximisation method, with an
induction of 5% test material applied for 48 hours exposure under
occlusive conditions, one week after induction injections. A challenge
exposure of 25% test material was applied under occlusive conditions, 24
hour exposure, two weeks after the induction. Test animals showed no
signs of sensitisation to the test material during the challenge and
observation periods. Based upon the results of the test, the test
material does not meet the criteria for classification under the EU
Classification, Labelling, and Packaging (CLP) regulation (1272/2008).
The substance has been tested for skin
sensitization in three studies of which only one study is suitable for
hazard evaluation. The oldest study (Merck 1980) was performed with five
animals per group and a non-standard testing design (Guinea pig
percutaneous skin sensitization assay by application with Q-tips). The
test substance was applied in pure form for induction and as a 10%
solution in peanut oil for challenge. Dinitrochlorobenzene was used as
positive control. Whereas dinitrochlorobenzene resulted in skin
reactions in all five animals, no skin reactions were observed for the
test or vehicle group animals. The study has obvious limitations such as
the low number of animals and the deviations from the OECD testing
later study (Merck 1985) is a maximization test according to Magnusson.
It was performed under GLP, but differs in reporting and performance
requirements from the requirements of OECD guideline 406. Most
importantly, no results of a pre-test are listed and no test substance
challenge of vehicle-induced animals was performed. It is therefore not
possible to decide whether the skin reactions observed upon challenge
with 50% in liquid paraffine are due to skin irritation or to skin
sensitization. This is particularly important since in the later study
(RCC 1999), the pre-experiment revealed skin irritation after treatment
with 50% in PEG400. Therefore, this study cannot be used for hazard
assessment and the results are unreliable (Klimisch 3). For further
information, 2% were used for intradermal induction and 50% for
most recent study (RCC 1999) was performed following OECD testing
guideline 406 and GLP. It fulfills all validity criteria (Klimisch 1).A
skin maximisation test in guinea-pig was performed with ten test and
five control guinea-pigs. The purity of the test material was 99.6%.
Concentrations for induction and epidermal challenge were chosen based
on the outcome of range-finding experiments. Intradermal induction
caused skin reactions at dose levels of 1, 3 and 5% and therefore 5%
which is the highest recommended concentration was chosen for the main
study. The vehicle was polyethylene glycol (PEG 400) with Freund's
Complete Adjuvant (FCA)/ physiological saline.
Epidermal induction was performed with
undiluted material. The pre-test had shown that skin reactions were
noted after treatment with 50, 75 and 100%, but not after treatment with
25%. Therefore, 25% was chosen as the challenge concentration.
the epidermal induction period, seven of the ten animals showed skin
reactions after treatment. After the epidermal challenge with the test
substance, none of the animals showed skin reactions. In contrast, 90%
of the animals were sensitized in the positive control group using
2-MERCAPTOBENZOTHIAZOLE as positive control substance. The
substance was found to be a non-sensitizer in this study.
The substance does not contain structural
alerts for protein binding as screened with the OECD QSAR toolbox v3.3
including the skin metabolism simulator.
Migrated from Short description
of key information:
To evaluate the allergic potential of the test substance, a skin
maximisation test (OECD 406, GLP) in ten test and five control
guinea-pig was performed. The test substance did not induce dermal
reactions in test animals 24h and 48h after challenge, respectively.
Thus, the test substance is considered to be as a non-sensitizer.
Labeling, and Packaging Regulation (EC) No. 1272/2008
available experimental test data are reliable and suitable for
classification purposes under Regulation 1272/2008. As a result the
substance is not considered to be classified for skin sensitization
under Regulation (EC) No. 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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