Registration Dossier

Administrative data

Endpoint:
in vivo mammalian germ cell study: cytogenicity / chromosome aberration
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study obtained through inquiry process; SNIF file obtained from ECHA.

Data source

Reference
Reference Type:
other: SNIF
Title:
Unnamed
Year:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Non-Annex V (Cytogenetics)
Deviations:
not specified
Principles of method if other than guideline:
This non-Annex V test was designed to detect nuclear anomalies (micronuclei, nuclear fragments and polyploidy) in erythrocytes and other bone marrow cells.
GLP compliance:
yes
Type of assay:
other: in vivo mammalian bone marrow cytogenetic test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Test animals

Species:
hamster, Chinese
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
0.5% aqueous sodium carboxymethylcellulose plus 0.1% Tween 80.
Frequency of treatment:
Dosing was on two consecutive days with animals being killed 24 hours later.
No. of animals per sex per dose:
Male: 0 mg/kg; No. of animals: 3; Sacrifice time: 48 hours
Male: 560 mg/kg; No. of animals: 3; Sacrifice time: 48 hours
Male: 1120 mg/kg; No. of animals: 3; Sacrifice time: 48 hours
Male: 2240 mg/kg; No. of animals: 3; Sacrifice time: 48 hours
Female: 0 mg/kg; No. of animals: 3; Sacrifice times: 48 hours
Female: 560 mg/kg; No. of animals: 3; Sacrifice times: 48 hours
Female: 1120 mg/kg; No. of animals: 3; Sacrifice times: 48 hours
Female: 2240 mg/kg; No. of animals: 3; Sacrifice times: 48 hours

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
not specified
Toxicity:
yes
Remarks:
Doses producing toxicity: In a preliminary test 1 out of 4 animals died after a single application of 2800 mg/kg. No effects evident in bone marrow.
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
other: Positive control gave a satisfactory response.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
The substance was non mutagenic under the conditions of the test.