Registration Dossier
Registration Dossier
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EC number: 435-560-9 | CAS number: 57090-45-6
Carcinogenicity
Administrative data
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The result was obtained from a publically available source which has been subject to peer-review and in which the original data sources are traceable.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
Materials and methods
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 3-chloropropane-1,2-diol
- EC Number:
- 202-492-4
- EC Name:
- 3-chloropropane-1,2-diol
- Cas Number:
- 96-24-2
- IUPAC Name:
- 3-chloropropane-1,2-diol
- Reference substance name:
- 3-Chloro-1,2-propanediol
- IUPAC Name:
- 3-Chloro-1,2-propanediol
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: Charles River CD
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- Three groups of 26 male and female Charles River CD rats received 3-chloro-1,2-propanediol at a dose of 0, 30, or 60 mg/kg bw by gavage twice weekly. After 10 weeks, the doses were increased to 35 and 70 mg/kg bw. The animals were treated for 72 weeks, and the study was terminated after 2 years.
- Frequency of treatment:
- Twice weekly.
- Post exposure period:
- 32 weeks
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0 mg/kg bw
Basis:
- Remarks:
- Doses / Concentrations:
30 mg/kg/bw
Basis:
- Remarks:
- Doses / Concentrations:
60 mg/kg/bw
Basis:
- No. of animals per sex per dose:
- Three groups of 26 male and female rats.
Examinations
- Other examinations:
- Three parathyroid adenomas were found in male rats at the higher dose, but this finding was not statistically significant with respect to the control group
Results and discussion
Results of examinations
- Details on results:
- While the females showed no signs of toxicity, male rats had a higher mortality rate than controls, and all treated males had severe testicular degeneration and atrophy.
Effect levels
- Dose descriptor:
- LOAEL
- Effect level:
- 30 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
Applicant's summary and conclusion
- Conclusions:
- Male rats showed severe testicular degeneration and trophy in all groups.
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