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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
Study period:
Jan. 1, 1984-Feb. 14, 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented publication/study report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: F. Winkelmann
- Weight at study initiation: 123 g female, 146 g male
- Fasting period before study:
- Housing: 1-5 animals in Makrolon cages,
- Diet (e.g. ad libitum): R10 Alleidiaet fuer Ratten, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 4-8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1 degree C
- Humidity (%): 60 +/- 5
- Air changes (per hr): 15/hr
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 12.5-19.9% in water

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

Doses:
LAS doses of 1075, 1220, 1360, 1710 or a control
Note that all doses are corrected for 86% activity. The original doses were 1250, 1415, 1580 and 1990 mg/kg.
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
Body weight and other signs were measured on days 7 and 14.
Animals were observed for 14 days after dosing.
Necropsies were performed at the end of the study.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 080 mg/kg bw
Based on:
act. ingr.
Mortality:
Virtually all animals died in doses of 1220 mg/kg and above.
Clinical signs:
Symptoms beginning about 30 minutes past application included diarrhea, squatting attitude, breathing difficulties, nose bleeding, ataxia, and lethargy. These symptoms had disappeared in surviving animals by 120 hours.
Body weight:
No effects to body weight were seen.
Gross pathology:
In the animals that died before the end of the study, red mucous was seen in the stomach and intestine. In the surviving animals, hyperemia of the stomach was noted, along with abnormalities of the stomach, liver, spleen, kidneys, and the peritoneum.

Any other information on results incl. tables

Mortality

Dose (mg/kg)

Sex

Mortality

1075

Male

0

Female

4

1220

Male

5

Female

3

1360

Male

4

Female

5

1710

Male

5

Female

5

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Conclusions:
The acute oral LD50 is 1080 mg/kg. According to EU GHS guidelines, the test substance is a Category IV toxicant.
Executive summary:

This study examined the oral toxicity of the test substance in rats. Groups of 5 male and 5 female rats were exposed orally to 0, 1075, 1220, 1360, or 1710 mg/kg of test substance. The animals were then monitored for 14 days for mortality and clinical signs. All animals showed signs of toxicity. Mortality was seen at all dose levels, with 4 of 10 animals at the lowest dose level dying. All animals at the highest dose level died. The acute oral LD50, when adjusted for activity was 1080 mg/kg. According to EU GHS guidelines, the test substance is a Category IV toxicant.