Registration Dossier

Diss Factsheets

Toxicological information

Genetic toxicity: in vivo

Currently viewing:

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: other: Micronucleus formation
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

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Type of assay:
micronucleus assay

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: Han Wister
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Details on exposure:
The highest dose was determined from a range-finding study in which single oral doses of 20–100 mg/kg bw were administered once daily for 2 days to groups of male and female rats; doses > 60 mg/kg bw per day were severely toxic and caused some deaths. Male animals were used in the main study, as no substantial sex difference in toxicity was seen.
Duration of treatment / exposure:
Groups of six males were given 3-chloro-1,2-propanediol orally at a dose of 15, 30, or 60 mg/kg bw per day for 2 days.
Doses / concentrations
Remarks:
Doses / Concentrations:
15, 30, 60mg/kg/day
Basis:

Results and discussion

Test results
Sex:
male
Genotoxicity:
negative
Toxicity:
yes
Remarks:
Piloerection was seen at the highest dose and was associated with a clear reduction in the ratio of polychromatic to normochromatic erythrocytes, indicating bone-marrow cytotoxicity.
Additional information on results:
There was no increase in the number of micronucleated polychromatic erythrocyte stem cells at any dose (2000 polychromatic erythrocytes scored per animal). Cyclophosphamide, used as the positive control, caused a clear increase in the number of micronuclei.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
The substance gave a negative result for this in-vivo test.