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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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