Registration Dossier
Registration Dossier
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EC number: 214-185-2 | CAS number: 1111-78-0
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline (OECD 401)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Principles of method if other than guideline:
- The study was conducted according to an internal BASF method whose principle is comparable to the OECD guideline 401. Test groups consisting of 5 animals/sex/group were treated by single gavage with an aqueous solution of the test substance in carboxymethylcellulose. The animals were weighed prior treatment, after day 7 and on day 13. The animals were observed for mortality and for clinical signs of toxicity for a period of 14 days. Decedents were were subjected to necropsy. At the end of the observation period, the surviving animals were sacrificed (CO2 aphyxiation) for the purpose of necropsy.
- GLP compliance:
- no
- Test type:
- standard acute method
Test material
- Reference substance name:
- Ammonium carbamate
- EC Number:
- 214-185-2
- EC Name:
- Ammonium carbamate
- Cas Number:
- 1111-78-0
- Molecular formula:
- CH3NO2.H3N
- IUPAC Name:
- ammonium carbamate
- Details on test material:
- - Name of test material (as cited in study report): Ammoniumcarbamat
- Analytical purity: >99.8%
- Substance number: 89/361
- Lot number: From March 1989
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, D-7950 Biberach, FRG
- Weight at study initiation: males 177-181 g, females 173-179 g
- Fasting period before study: approx. 16 hours before administration.
- Housing: 5 per Stainless Steel wire mesh cage
- Diet (ad libitum?): Yes, KLIBA-Labordiaet 343, Klingentalmuehle AG, 4303 Kaiseraugst
- Water (ad libitum?): Yes, Tap water
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12h/12h
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2.15, 6.810, 14.70 g/100 ml
- Justification for choice of vehicle: aqueous solution corresponds to the physiological medium
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg - Doses:
- 215, 681, 1470 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Observation period:
- Duration: 14 days
Clinical signs:
- Time schedule for examination: several times on the day of administartion. At least once each workday.
Mortality:
- Time schedule for examination: twice each workday and once on holidays.
Body weights:
- Time schedule: before administration, on day 7 and on day 13
Sacrifice:
- Method: CO2 asphyxiation:
- Fasting: Yes, 16 hours prior to sacifice
Necropsy:
- Number of animals: all animals; killed because of moribundity, found dead or sacrificed at termination
- Examination: Gross pathology
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 681 - < 1 470 mg/kg bw
- Remarks on result:
- other: Clinical signs of toxicity: poor general state, apathy, scrubby fur, staggering, dyspnoea
- Mortality:
- 215 mg/kg bw: no deaths
681 mg/kg bw: 1 animal of each sex died within the first 24 hours
1470 mg/kg bw: All animals died within the first 24 hours - Clinical signs:
- other: 215 mg/kg bw: no clinical signs 681 mg/kg bw: Apathy, scrubby fur 1470 mg/kg bw: Poor general state, apathy, scrubby fur, staggering, dyspnoea
- Gross pathology:
- No pathological findings noted.
Any other information on results incl. tables
Dose (mg/kg bw) |
Mortality |
|||||||||
1 hour |
1 day |
2 days |
7 days |
14 days |
||||||
male |
female |
male |
female |
male |
female |
male |
female |
male |
female |
|
215 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
0/5 |
681 |
0/5 |
0/5 |
1/5 |
1/5 |
1/5 |
1/5 |
1/5 |
1/5 |
1/5 |
1/5 |
1470 |
0/5 |
0/5 |
5/5 |
5/5 |
5/5 |
5/5 |
5/5 |
5/5 |
5/5 |
5/5 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Migrated information: (of moderate toxicity after single ingestion)
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