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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian cell study: DNA damage and/or repair
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
GLP compliance:
yes
Type of assay:
mammalian bone marrow chromosome aberration test

Test material

Constituent 1
Chemical structure
Reference substance name:
2-hydroxy-2-methylpropionitrile
EC Number:
200-909-4
EC Name:
2-hydroxy-2-methylpropionitrile
Cas Number:
75-86-5
Molecular formula:
C4H7NO
IUPAC Name:
2-hydroxy-2-methylpropionitrile

Test animals

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
No
Duration of treatment / exposure:
Acute exposure
Frequency of treatment:
Single administration
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw (total dose)
Dose / conc.:
1.5 mg/kg bw (total dose)
Dose / conc.:
5 mg/kg bw (total dose)
Dose / conc.:
15 mg/kg bw (total dose)
No. of animals per sex per dose:
6 rats/sex/dose
Control animals:
yes, concurrent vehicle
Positive control(s):
Cyclophosphamide monohydrate

Examinations

Statistics:
The mean mitotic indices, mean modal numbers, percent aberrant cells and the mean number of aberrations per cell for each group were statistically compared using the Kruskal-Wallis nonparametric analysis of variance and nonparametric pairwise group comparisons (KW-ANOVA). Body weight data was analyzed by analysis of covariance (ANCOVA). All tests were one-tailed at the 95% confidence interval (p < .05).

Results and discussion

Test results
Key result
Sex:
male/female
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
valid
Positive controls validity:
valid
Additional information on results:
Results show that no statistically significant increases in the frequency of chromosomal aberrations compared to control values were seen for any of the dose levels that were tested with acetone cyanohydrin. No significant differences were seen in the mean modal numbers or mitotic indices of the test groups when compared to control values.

Applicant's summary and conclusion

Conclusions:
The acute oral administration of 1.5. 5 and 15 mg/kg body weight of Acetone Cyanohydrin to male and female rats produced no significant increases in the frequency of chromosomal aberrations. No significant difference was observed between the negative control and test groups when comparing modal numbers or mitotic index. Therefore, under the conditions of this study, Acetone Cyanohydrin is considered not to be clastogenic at any of the levels tested.