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Toxicological information

Acute Toxicity: oral

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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:
1989
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

Constituent 1
Chemical structure
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

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:
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
Body weight:
Body weight gain was generally observed in the course of the study.
215 mg/kg bw: ♂ 289g after 13 days; ♀ 214 g after 13 days
681 mg/kg bw: ♂ 274 after 13 days; ♀ 216 after 13 days
Gross pathology:
No pathological findings noted.

Any other information on results incl. tables

Dose (mg/kg bw)

Mortality 
(Died/Treated)

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)