Registration Dossier
Registration Dossier
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EC number: 700-225-0 | CAS number: 1160806-44-9
Endpoint summary
Administrative data
Description of key information
SKIN IRRITATION
No animal data is available.
In vitro EpiDerm™ Test: Effects indicating an irritant property were observed, but there was no indication of a corrosive property (BASF SE, 2009).
Classification / labeling: Irritating to the Skin (R 38)
EYE IRRITATION
No animal data is available.
In vitro HET-CAM Test: No effects on chorioallantoic membrane were observed (BASF SE, 2009).
Classification / labeling: Irritating to the eye (R 36).
RESPIRATORY IRRITATION
No data is available.
Key value for chemical safety assessment
Additional information
SKIN IRRITATION
No animal data is available.
In an in vitro EpiDerm™ Test (BASF SE, 2009), EpiDerm™ tissue samples were incubated with unchanged, semi-solid 2-Methyl-3,4-dibrombuttersäureethylester (ca. 98% pure), according to the methods of the Corrosion test and the Irritation test. For the corrosion test, two EpiDerm™ tissue samples were incubated with the test item for 3 minutes and 1 hour, respectively. The irritation test was performed with three EpiDerm™ tissue samples, which were incubated with the test item for 1 hour followed by a 42-hours post-incubation period. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as suitable endpoint. The formazan production of the test item treated epidermal tissues is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability. The test was carried out in accordance with OECD TG 431.
2-Methyl-3,4-dibrombuttersäureethylester was not able to reduce MTT directly. In the Corrosion test, the mean viability of the test-item treated tissues determined after an exposure period of 3 minutes was 142%, and it was 98% after an exposure period of 1 hour. In the Irritation test, the mean viability of the test-item treated tissues determined after an exposure period of 1 hour with about 42 hours post-incubation was 5%. Based on the observed results and applying the evaluation criteria, it was concluded that 2-Methyl-3,4-dibrombuttersäureethylester shows a skin irritation potential in the EpiDerm™ skin corrosion/irritation test under the test conditions chosen.
EYE IRRITATION
No animal data is available.
In an in vitro HET-CAM Test (BASF SE, 2009), 2-Methyl-3,4-dibrombuttersäureethylester (ca. 98% pure) was applied to the chorioallantoic membrane (CAM) of fertilized and incubated hen eggs, either undiluted or as a 10% solution in olive oil (single topical application of aliquots of 0.3 ml of the respective test material). Three eggs per test-substance concentration were observed up to a maximum of 160 seconds and the occurrence of vascular injury or intravascular coagulation in response to the test substance was recorded.
The chorioallantoic membrane of all eggs did not show any irritation effects. Based on the results of this study and applying the evaluation criteria, it is concluded that 2-Methyl-3,4-dibrombuttersäureethylester does not produce changes indicative for serious eye damage in the HET-CAM Test under the test conditions chosen. However, the test method does not yet allow for the evaluation of eye irritation. The result does not exclude an irritation potential of the test item. For final assignment of a risk phrase at present, results from an in vivo study would be needed.
RESPIRATORY IRRITATION
No data is available.
Justification for classification or non-classification
Based on the results of the in vitro EpiDerm™ test, 2-Methyl-3,4-dibrombuttersäureethylester has to be classified as follows: Irritating to the Skin (R 38) according to the Directive 67/548/EC. According to the GHS criteria, 2 -Methyl-3,4 -dibrombuttersäureethylester has to be classified as follows: Irritating to the skin, Cat 2.
There is no indication that 2-Methyl-3,4-dibrombuttersäureethylester is able to produce serious damage to the eye. However, this is based on an in vitro eye corrosion test (HET-CAM test) only. For final assignment of a risk phrase at present, results from another study would be needed. Based on safety considerations, 2-Methyl-3,4-dibrombuttersäureethylester is tentatively classified as irritating to the eye and has to be classified as follows: Irritating to the eye (R 36) according to the Directive 67/548/EC. According to the GHS criteria, 2-Methyl-3,4-dibrombuttersäureethylester has to be classified as follows: Irritating to the eye, Cat. 2A.
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