Registration Dossier
Registration Dossier
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EC number: 244-121-9 | CAS number: 20941-65-5
Carcinogenicity
Administrative data
Description of key information
Due to methodological deficiencies, carcinogenic potential of the test substance could not be determined.
Key value for chemical safety assessment
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
No reliable data on carcinogenicity of the substance are available for assessment.
Additional information
In a pre-GLP and pre-OECD carcinogenicity study (NCI, 1979), 50 rats per sex, were orally exposed (feed) to 150, 300 and 600 ppm of the test substance for 105 weeks, along with 20 control animals for each sex. Animals were observed twice daily. All surviving animals were killed after treatment and pathologic evaluation of gross and microscopic examination of major tissues was performed. No carcinogenic effects were observed in the female rat. Equivocal results were observed in the male rat. The study is considered not reliable (reliability 3) due to methodological deficiencies (exceeded MTD, control group too small).
In a pre-GLP and pre-OECD carcinogenicity study (NCI, 1979), 50 mice per sex, were orally exposed (feed) to 1255, 2132, 3132 or 4915 ppm (time-weighted average dose) of the test substance for 106 weeks, along with 20 control animals for each sex. Animals were observed twice daily. All surviving animals were killed after treatment and pathologic evaluation of gross and microscopic examination of major tissues was performed. Equivocal carcinogenic effects were observed in the male and female mice. The study is considered not reliable (reliability 3) due to methodological deficiencies (exceeded MTD, control group too small, non-malignant tumours).
In a pre-GLP and pre-OECD carcinogenicity study (NTIS, 1968), 18 rats per sex per strain (2 strains), were orally exposed (gavage and feed) to 46.6 mg/kg bw/day of the test substance for 78 weeks, along with 18 control animals for each sex per strain. Animals were observed daily. All surviving animals were killed after treatment and pathologic evaluation was performed. Significant increases in pulmonary ademonas and hepatomas were observed. The study is considered not reliable (reliability 3) due to methodological deficiencies (treatment too short, treatment groups too small, control group too small).
In a pre-GLP and pre-OECD carcinogenicity study (NTIS, 1968), 18 rats per sex per strain (2 strains), were subcutaneously exposed to one injection of 1000 mg/kg bw of the test substance, along with 18 control animals for each sex per strain. Animals were observed daily. All surviving animals were killed after treatment and pathologic evaluation was performed. No significant carcinogenic effecs were observed. The study is considered not reliable (reliability 3) due to methodological deficiencies (unusual treatment, treatment groups too small, control group too small).
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