Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 235-185-9 | CAS number: 12125-01-8
Genetic toxicity: in vivo
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 from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented study published in the international journal.
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. and Ishidate, M.
- Year:
- 1 988
- Bibliographic source:
- Food and Chemical Toxicology 26(6): 487-500
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: no data
- Deviations:
- not specified
- GLP compliance:
- no
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Ammonium chloride
- IUPAC Name:
- Ammonium chloride
- Details on test material:
- Japan Food Additives Association, purity: 99.7%
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: T23-48:ddY
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- see below
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- see below
- Details on exposure:
- see below
- Duration of treatment / exposure:
- 24 hours after injection
- Frequency of treatment:
- see below
- Post exposure period:
- see below
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
(1)Single injection: 0, 62.5, 125, 250, 500mg/kg
Basis:
- Remarks:
- Doses / Concentrations:
(2)Four injections with 24hr intervals: 0, 31.3, 62.5, 125, 250mg/kg
Basis:
- No. of animals per sex per dose:
- see below
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Positive control: mitomycin C 2.0 mg/kg
Examinations
- Tissues and cell types examined:
- no data
- Details of tissue and slide preparation:
- see below
- Evaluation criteria:
- see below
- Statistics:
- see below
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Additional information on results:
- none
Any other information on results incl. tables
Single injection (i.p.)
------------------------------------------------------------
Test substance MNPCE(%) PCE(%) Mortality
------------------------------------------------------------
Saline 0.18+/-0.18 56.8+/-4.7 0/6
Ammonium chloride
62.5(mg/kg) 0.12+/-0.12 60.9+/-4.2 0/6
125(mg/kg) 0.15+/-0.14 61.7+/-3.8 0/6
250(mg/kg) 0.13+/-0.05 64.3+/-2.5 0/6
500(mg/kg) 0.12+/-0.08 56.9+/-6.1 0/6
Mitomycin C 2.0(mg/kg) 4.18+/-1.30* 52.3+/-4.6 0/6
-----------------------------------------------------------
Four times injection every 24 hours (i.p.)
------------------------------------------------------------
Test substance MNPCE(%) PCE(%) Mortality
------------------------------------------------------------
Saline 0.20+/-0.09 59.9+/-8.3 0/6
Ammonium chloride
31.3(mg/kg) 0.25+/-0.19 67.2+/-13.5 0/6
62.5(mg/kg) 0.17+/-0.10 63.7+/-4.5 0/6
125(mg/kg) 0.20+/-0.18 64.0+/-9.2 0/6
250(mg/kg) 0.17+/-0.08 61.6+/-6.9 0/6
Mitomycin C 2.0(mg/kg) 7.15+/-3.92* 32.2+/-11.0 0/6
------------------------------------------------------------
*:p<0.01
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Micronucleus test with test substance on male mice gave negative result.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
