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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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity: 97.0%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF-Zucht
- Age at study initiation: no data
- Weight at study initiation: males: 179 g - 202 g (average 191 g); females: 173 g - 204 g (average 188 g)
- Fasting period before study: about 16 hours
- Housing: 5 animals per makrolon cage
- Diet: Altromin 1324 rat diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): no data
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Sesame oil
Details on oral exposure:
- Concentration in vehicle: 10,0, 12.5, 14.0, 16.0, 20.0%
- Dose volume applied: 10.0 ml/kg bw
Doses:
1000, 1250, 1400, 1600, 2000 mg/kg bw
No. of animals per sex per dose:
5
Details on study design:
- Duration of observation period following administration: 14 days and 21 days for the group of female rats exposed to 1600 mg/kg bw.
- Frequency of weighing: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology, histopathology

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
1 270 mg/kg bw
Based on:
test mat.
95% CL:
ca. 1 050 - <= 1 560
Sex:
female
Dose descriptor:
LD50
Effect level:
1 490 mg/kg bw
Based on:
test mat.
95% CL:
>= 1 210 - <= 1 750
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 380 mg/kg bw
Based on:
test mat.
95% CL:
>= 1 220 - <= 1 560

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The LD50 value for acute oral toxicity is 1270 mg/kg bw in male Wistar rats and 1490 mg/kg bw in female Wistar rats.