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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Interfauna (UK) Limited, Wyton, Huntingdon
- Age at study initiation: five to eight weeks old
- Weight at study initiation: 122 - 145 g males; 120 - 142 g females
- Fasting period before study: overnight
- Housing: in groups of up to five by sex in solid-floor polypropylene cages with sawdust bedding
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-24
- Humidity (%): 50-68
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 100-200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
Doses:
1000, 1260, 1587 and 2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
observations: 1 and 4 hours after dosing and subsequently once daily for 14 days
weighing: on the day of treatment (day 0), day 7 and 14, or at death
- Necropsy of survivors performed: yes
Statistics:
Probit Analysis

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
1 844 mg/kg bw
95% CL:
1 395 - 2 437
Sex:
female
Dose descriptor:
LD50
Effect level:
1 682 mg/kg bw
95% CL:
1 218 - 2 323
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 687 mg/kg bw
95% CL:
1 464 - 2 406
Mortality:
One animal was found dead one hour after treatment. All other deaths were noted one to six days after treatment.
Clinical signs:
All animals: hunched posture, pilo-erection, decreased respiration rate (1 to 4 h after dosing). Some of the symptoms were observed up to days 6 to 9 in surviving animals of the 1587 mg/kg bw group and up to day 11 in those of the high dose group. Additional symptoms at 1587 mg/kg bw: lethargy, ptosis pallor of the extremities, red/brown staining around the snout, emaciation (females, from day 6)
Body weight:
In most of the animals body weight gain was noted. Isolated cases of body weight loss or reduced bw gain were reported.
Gross pathology:
Common abnormalities of animals that died during the study: red lungs, pale or dark or patchy pallor of livers. At 1587 and 2000 mg/kg bw: severe haemorrhage and rugae of the glandular gastric epithelium. Occasional adherence of stomach to the liver. In the surviving animals killed at termination occasional findings were white foci in the non-glandular gastric epithelium and adherence of the stomach to the liver.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
Migrated information
Conclusions:
The acute oral median lethal dose (LD50) and the 95% confidence limits of the test material in the Sprangue-Dawley CFY strain rat were calculated by the probit method to be:
All animals: 1687 (1464 - 2406) mg/kg bodyweight
Males only: 1844 (1395 - 2437) mg/kg bodyweight
Females only: 1682 (1218 -2323) mg/kg bodyweight