Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Published study

Data source

Reference
Reference Type:
publication
Title:
Micronucleus Tests in Mice on 39 Food Additives and Eight Miscellaneous Chemicals
Author:
Hayashi, M. Kishi, M. Sofuni, T. Ishidate, M. Jr.
Year:
1988
Bibliographic source:
Food and Chemical Toxicology, 26(6): 487-500

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Ammonium chloride
EC Number:
235-186-4
EC Name:
Ammonium chloride
Cas Number:
12125-02-9
Molecular formula:
H4ClN
IUPAC Name:
Ammonium chloride
Constituent 2
Reference substance name:
Ammmonium chloride
IUPAC Name:
Ammmonium chloride
Details on test material:
Ammonium chloride, purity 99.7%. Read-across is proposed because ammonium chloride dissociates in aqueous environments producing ammonia.

Test animals

Species:
mouse
Strain:
other: ddY
Sex:
male
Details on test animals or test system and environmental conditions:
The animals were 8 week old male ddY mice (Shizuoka Agricultural Cooperative Association for Laboratory Animals). They were given CE-2 pellets (Japan Clea, Tokyo) and water ad libitum.

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
No information
Details on exposure:
Ammonium chloride was injected i.p. 5 doses were given as a single injection, 4 doses were given as 4 injections within 24 hours.
Duration of treatment / exposure:
Mice were sacrificed 24 hours after exposure
Frequency of treatment:
Single i.p. injection, or 4 injections in 24 hours
Post exposure period:
24 hours
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day
Remarks:
single injection
Dose / conc.:
62.5 mg/kg bw/day
Remarks:
single injection
Dose / conc.:
125 mg/kg bw/day
Remarks:
single injection
Dose / conc.:
250 mg/kg bw/day
Remarks:
single injection
Dose / conc.:
500 mg/kg bw/day
Remarks:
single injection
Dose / conc.:
31.3 mg/kg bw/day
Remarks:
four injections within 24 hours
Dose / conc.:
62.5 mg/kg bw/day
Remarks:
four injections within 24 hours
Dose / conc.:
125 mg/kg bw/day
Remarks:
four injections within 24 hours
Dose / conc.:
250 mg/kg bw/day
Remarks:
four injections within 24 hours
No. of animals per sex per dose:
5
Control animals:
yes
Positive control(s):
Positive controls were not included, the study was a test on 47 chemicals.

Examinations

Tissues and cell types examined:
Femoral bone marrow cells, examined for polychromatic erythrocytes
Details of tissue and slide preparation:
Femoral bone marrow cells were flushed out with foetal bovine serum, fixed with methanol and stained with Giemsa.
Evaluation criteria:
1000 polychromatic erythrocytes per mouse were scored using a light microscope and the number of micronucleated erythrocytes was recorded.
Statistics:
No information

Results and discussion

Test results
Sex:
male
Genotoxicity:
negative
Toxicity:
yes
Vehicle controls validity:
valid
Negative controls validity:
not applicable
Positive controls validity:
not specified
Additional information on results:
The occurrence of micronucleated erythrocytes after single injection was 0.12%, and after four injections was 0.17%.

Any other information on results incl. tables

The occurrence of micronucleated erythrocytes after single injection was 0.12%, and after four injections was 0.17%.

Applicant's summary and conclusion

Conclusions:
Interpretation of results: negative
Ammonium chloride was negative for genotoxicity in the mouse micronucleus assay.
Executive summary:

The potential for the genotoxicity of ammonium chloride was investigated in a bone marrow micronucleus assay in mice. Male ddY mice were administered ammonium chloride by single intraperitoneal injection at dose levels of 0, 62.5, 125, 250 or 500 mg/kg bw or as four injections within 24 hours at dose levels of 31.3, 62.5, 125 or 250 mg/kg bw. The maximum dose of ammonium chloride was determined by pilot experiments using the multisampling at multi-dose levels method. Dose levels of up to the maximum tolerated dose were used. Mice were killed 24 h after administration and femoral bone marrow cells were harvested, fixed and stained. 1000 PCEs per animal were scored using a light microscope and the number of micronucleated erythrocytes (MnPCEs) recorded. No evidence of genotoxicity was seen under the conditions of this assay.