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Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
No data.
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
2008

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
GLP compliance:
not specified
Type of assay:
micronucleus assay

Test material

Constituent 1
Reference substance name:
Hydroxylammonium sulphate
IUPAC Name:
Hydroxylammonium sulphate
Test material form:
not specified
Details on test material:
No data.

Test animals

Species:
mouse
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
No data.

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
No data.
Details on exposure:
Oral (no specific route specified).
Duration of treatment / exposure:
A single oral administration.
Frequency of treatment:
A single oral administration.
Post exposure period:
16, 24 and 48 hours.
Doses / concentrations
Remarks:
Doses / Concentrations:
300, 600 and 1200 mg/kg bw
Basis:
no data
No. of animals per sex per dose:
5/sex/dose.
Control animals:
not specified
Positive control(s):
No data

Examinations

Tissues and cell types examined:
Polychromatic erythrocytes.
Details of tissue and slide preparation:
No data.
Evaluation criteria:
No data.
Statistics:
No data.

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
yes
Remarks:
Toxic effects at all doses.
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
All doses led to toxic signs (not reported further), there were no clear effects on local cytotoxicity. PCE/NCE ratios were not altered.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
A single oral administration of either 300, 600 or 1200 mg hydroxylammonium sulphate/kg bw gave negative results in a mice micronucleus test. All doses led to toxic signs.
Executive summary:

In a mouse (5/sex/dose) micronucleus assay on polychromatic erythrocytes, hydroxylammonium sulphate gave negative results after adminstration of a single dose of either 300, 600 or 1200 mg/kg bw. All doses led to toxic signs, although there were no alterations to the PCE/NCE ratio. By this study design hydroxylammonium sulphate is considered non-genotoxic in vivo in mice. This study is considered reliable with restrictions.