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Toxicological information

Carcinogenicity

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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

Constituent 1
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
Constituent 2
Reference substance name:
3-Chloro-1,2-propanediol
IUPAC Name:
3-Chloro-1,2-propanediol

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.