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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 243-231-4 | CAS number: 19694-10-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: study was carried out according to test guidline OECD401 and under GLP-conditions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 3-amino-4-chlorobenzamide
- EC Number:
- 243-231-4
- EC Name:
- 3-amino-4-chlorobenzamide
- Cas Number:
- 19694-10-1
- Molecular formula:
- C7H7ClN2O
- IUPAC Name:
- 3-amino-4-chlorobenzamide
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: Hoe WISKf (SPF 71)
- Source: Hoechst AG, Kastengrund, SPF breeding stock
- Weight at study initiation: male: 156 - 216g (average 189g); female: 190 - 205g (average 198g),
- Fasting period before study: 16 hours prior to administration and 3-4 hours after administraion
- Housing: macrolon cages/airconditioned rooms
- Diet: Altromin 1324, ad libitum
- Water. tap water, ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle:
5.0% (w/v) for 500 mg/kg bw
6.3% (w/v) for 630 mg/kg bw
8.0% (w/v) for 800 mg/kg bw
10.0% (w/v) for 1000 mg/kg bw
16.0% (w/v) for 1600 mg/kg bw - Doses:
- male:
500 mg/kg bw
630 mg/kg bw
800 mg/kg bw
1000 mg/kg bw
1600 mg/kg bw
female:
500 mg/kg bw - No. of animals per sex per dose:
- 5 males for each testing dose --> total of 25 male rats
5 females for the 500 mg/kg bw testing dose - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of body weighing: 1/week
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, necropsy
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 900 mg/kg bw
- 95% CL:
- >= 618 - <= 1 710
- Remarks on result:
- other: first lethality observed at 500 mg/kg bw dose
- Sex:
- female
- Remarks on result:
- other: females did not react more sensitive than males; no lethality observed at 500 mg/kg bw dose
- Mortality:
- Dose (mg/kg bw) Mortality
Male:
500 1/5
630 2/5
800 1/5
1000 2/5
1600 5/5
Female:
500 0/5 - Clinical signs:
- other: males and females: Squatting posture, irregular respiration, reduced spontaneous activity, flanks pinched in, prone or lateral position, forward crawling, reduced or no placing reflex; in single cases coat bristling, stilted gait, ataxic gait, uncoordinat
- Gross pathology:
- male non-survivors:
lever stronglydarkened
lung darkly spotted
lung lightened
gastro-intestinal system filled with prepared sample and gas
remarkably injected vascular walls of small intestine
male survivors dissected after post-observation period:
no macroscopic effects
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 was 900 mg/kg bw after single oral gavage in male rats (female rats not more sensitive).
Classification: H402, Cat.4 according to EC 1272/2008. - Executive summary:
Male and female Wistar-rats were subjected to test acute oral toxicity. The test substance was administered by gavage at doses from 500 to 1600 mg/kg bw for males (5 to 16% suspension in water) and 500 for females (5% suspension in water). First lethality for males was observed at 500mg/kg bw (1 of 5) up to 5 of 5 animals at 1600 mg/kg bw. No lethality observed for males at 500 mg/kg bw.
LD50 is determined to 900 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.
