Registration Dossier

Administrative data

Endpoint:
in vivo mammalian germ cell study: cytogenicity / chromosome aberration
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read across to related substance with same EC number (410-190-0) identified during Inquiry Process (Inquiry number: 06-0000021779-56-0000). Previous data (>12 yrs old) provided by ECHA.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Micronucleus study (See comments)
GLP compliance:
yes
Type of assay:
other: non-bacteriological test in vivo - 6th Amendment data

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
dermal
Vehicle:
Neat substance
No. of animals per sex per dose:
Female: 0 mg/kg; no. of animals: Sacrifice times: hours
Female: 125 mg/kg; no. of animals: Sacrifice times: hours
Female: 500 mg/kg; no. of animals: Sacrifice times: hours
Female: 2000 mg/kg; no. of animals: Sacrifice times: hours

Results and discussion

Test results
Toxicity:
yes
Remarks:
(doses producing toxicity: P/N Ratio: No change was observed. Other Toxic signs: None)
Additional information on results:
Observations:
There was no increase in micronucleus formation

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
The in vivo chrommosome aberration test was negative for the surrogate substance EC 410-190-0.