(R)-3-chloropropane-1,2-diol

Genetic toxicity: in vivo

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

Test material information

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.