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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 941-237-8 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well described, acceptable study. Test substance purity, guideline: not mentioned. No GLP.
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: not mentioned
- Deviations:
- no
- Principles of method if other than guideline:
- No guideline is mentioned in the reference document. The standard acute method is well described.
Animal: rat
Aplication form: solution in aqua dest.
Oral gavage
Dose (mg/kg): from 681 to 2150
Observation period: 14 days - GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Ammonium chloride
- EC Number:
- 235-186-4
- EC Name:
- Ammonium chloride
- Cas Number:
- 12125-02-9
- Molecular formula:
- ClH4N
- IUPAC Name:
- ammonium chloride
- Details on test material:
- Substance name: Salmiak fein weiss; substance no.:83/44, Ammonium Chloride; NH4Cl.
No further details.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- -Test Organisms:
a)Breeder: Dr.K.THOMAE GmbH, Biberach, Germany
b)Acclimatization: for at least one week in the animal care unit c
)Weight at study initiation: male;170-178g, female;171-187g
d)No. of animals per dose: 10 males and 10 females
e)Feeding: Diet;SSNIFF R, Ssniff Versuchstierdiaeten, Soest, Germany Water;Tap water
f)Fasting period: The animals are given no feed for 16 hours before administration, but water is available ad libitum.
-Test Conditions
a)Temperature: 20-26 degree C in fully air-conditioned room
b)Humidity: 30-70%
c)Lightning: 12hr-light, 12hr-dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Form of administration: solution in bidistilled water
Type of administration: single oral administration by gavage - Doses:
- Dose (mg/kg): 2150, 1780, 1470, 1000, 681
- No. of animals per sex per dose:
- 10 males and 10 females
- Control animals:
- not specified
- Details on study design:
- Post dose observation period: 14 days
-Examinations:
a)Mortality
b)Body weight
c)Clinical sings and symptoms
d)Pathology: necropsy and gross-pathological examination (Heart, Stomach, Intestines) - Statistics:
- no data
Results and discussion
- Preliminary study:
- not relevant
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 410 mg/kg bw
- Mortality:
- -Mortality: (out of 10 males and 10 females) a)Number of dead males at dose,2150/1780/1470/1000/681: (after 1h) 8/7/4/0/0, (after 1d) 8/7/4/0/0, (after 2-14d)8/7/4/0/0 b)Number of dead females at dose, 2150/1789/1470/1000/681: (after 1h) 10/9/7/0/0, (after 1d) 10/9/7/3/0, (after 2-14d)10/9/7/3/0
- Clinical signs:
- other: -Clinical Signs and Symptoms: at a dose of 1000 mg/kg or higher, Dyspnea, apathy, abnormal position and staggering were observed in 15min to 2hr.
- Gross pathology:
- -Necropsy Findings:(Heart) dilatation bilaterally; sporadically dilatation on the left side (Stomach) atonic several times; liquid contents; malacia of the mucosa in the glandular stomach (Intestines) atonic, diarrheal and mucous contents; malacia of the mucosa in several cases. In necropsy findings, no abnormalities were detected in surviving animals.
- Other findings:
- -Sex-specific Differences:(Male) LD50=1630mg/kg; slope factor=1.29 (Probit analysis) (Female) LD50=1220mg/kg; slope factor=1.31(M & F) LD50=1410mg/kg; slope factor=1.36
Any other information on results incl. tables
Sex dose (mg/kg bw) number of animals number of deaths
M 2150 10 8
1780 10 7
1470 10 4
1000 10 0
681 10 0
F 2150 10 10
1780 10 9
1470 10 7
1000 10 3
681 10 0
Deaths were found 1 hour after dosing (males and females dosed at 1470 or higher) or 1 day after dosing (females dosed at 1000 mg/kg bw)
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD50 for males and females combined was 1410 mg/kg bw.
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.
