Registration Dossier
Registration Dossier
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EC number: 210-890-4 | CAS number: 625-36-5
Carcinogenicity
Administrative data
Description of key information
No approproate data available.
Key value for chemical safety assessment
Justification for classification or non-classification
Based on the available study examining a structural analogue of the test substance, classification for carcinogenicity is not possible in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.
Additional information
No studies on the carcinogenicity of 3 -chloropropionyl chloride were available. However, Article 13 of REACH states that, in case no appropriate animal studies are available for assessment, information should be generated whenever possible by means other than vertebrate animal tests, i.e. applying alternative methods such as in vitro tests, QSARs, grouping and read-across. One carcinogenicity study is available for the structural analogue 3- Chloropropionic acid.
In a in vivo carcinogenicity study by Theiss (1979), the abilities of 28 organohalides (of which the test substance) to induce lung tumors in strain A mice were investigated. Groups of 20 mice (10 males and 10 females were given 3 times weekly i.p. injections for a maximum of eight weeks with 0.14, 0.28, and 0.56 mmol/kg test substance dissolved in 0.9% NaCl solution. Twenty-four weeks after the first injection, the mice were sacrificed. The frequency of lung tumors in each chemically treated group was statistically compared with that in the appropriate vehicle-treated control group. In the control group all animals survived and the average number of lung tumors per mouse was 0.10 ± 0.10. At 0.14 mmol/kg 19/20 animals survived and the average number of lung tumors per mouse was 0.32 ± 0.11. At 0.28 mmol/kg all animals survived and the average number of lung tumors per mouse was 0.20 ± 0.12. At the highest doese of 0.56 mmol/kg only 12 injections (instead of 24) were given due to toxicity concerns. Only 10/20 animals survived treatment and the average number of lung tumors per mouse was 0.90 ± 0.28, which was statistally significant compared to control. In this study there were only 3 doses tested of which the highest dose exceeded the maximum tolerated dose. I.p injection is not a relevant exposure route for this type of examination. In addition, only 20 animals per dose were tested (instead of at least 50) and only a 8 week exposure protocol was used and test was terminated 24 weeks after first injection. Therefore, the results from this particular study are not suitable for assessment of the carcinogenic potential of the test substance.
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