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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:
1992-02-05 - 1992-03-11
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Remarks:
Limited information on the test substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
equivalent or similar 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 material form:
liquid
Details on test material:
- Physical state: liquid
- Storage condition of test material: Room temperature
Specific details on test material used for the study:
- Name as cited in study report: 6398-9-20
- Color: clear
- Storage: during storage no change in the physical state of test article
- Specific gravity: 0.948 g/mL

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories Inc., Wilmington, Massachusetts, USA
- Age at study initiation: 6-10 weeks
- Weight at study initiation: 155-291 g (dose-range finder), 157-232 g (main test); weight variation in each sex did not exceed +/- 20%
- Fasting period before study: yes
- Housing: individually in stainless steel wire mesh cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30-70 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 4.22 ml/kg bw (based on max. dose level 4000 mg/kg bw and specific gravity 948 mg/ml)

DOSAGE PREPARATION (if unusual): test article was dosed as received using specific gravity calculations.

Doses:
0 (water), 2000, 2500, 3000, 4000 mg/kg bw
No. of animals per sex per dose:
5 substance exposed animals, 3 control animals
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations at 1h, 4h, 24h after dosing and once daily thereafter; body weights at 0h, 7d and 14d after exposure (or when found dead).
- Necropsy of survivors performed: yes
- Other examinations performed: toxicological effects, viability, gross necropsy, histopathology (of control and highest dose group)
Statistics:
LD50 calculations according to Litchfield and Wilcoxon.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 885.3 mg/kg bw
Based on:
test mat.
95% CL:
>= 2 400.7 - <= 3 467.7
Sex:
male
Dose descriptor:
LD50
Effect level:
2 922.1 mg/kg bw
Based on:
test mat.
95% CL:
>= 2 308.9 - <= 3 698.2
Sex:
female
Dose descriptor:
LD50
Effect level:
2 627.2 mg/kg bw
Based on:
test mat.
95% CL:
>= 2 157.7 - <= 3 198.8
Mortality:
No mortality in 6 control rats (3M/3F)
2000 mg/kg: 1/5 females
2500 mg/kg: 3/5 males and 2/5 females
3000 mg/kg: 1/5 males and 3/5 females
4000 mg/kg: 5/5 males and 5/5 females
All deads occurred on or 1 day after the day of exposure.
Clinical signs:
Decreased activity during the first few days after exposure only (only for substance exposed rats).
Dyspnea during the first few days after exposure only (in 2500-3000-4000 dosed rats)
Body weight:
No remarkable findings
Gross pathology:
In exposed animals that died during the study: distended stomach and intestines (all dose levels), dark or pale organs (3000 and 4000 mg/kg).
No visible lesions in control animals and all survivors.
Other findings:
No treatment related findings compared to control rats.

Applicant's summary and conclusion

Interpretation of results:
not classified
Conclusions:
In view of the LD50 value of 2885 mg/kg bw in this rat study, the substance does not need to be classified for acute orale toxicity according to DSD, nor according to CLP.