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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:
02 December - 20 December, 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Limited information about substance identity and no GLP.

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
(deleted in december 2002)
Deviations:
yes
Remarks:
Not all clinical examinations performed (body weight, necropsy), but considered not to have affected the outcome of the study.
GLP compliance:
no
Remarks:
performed before GLP was in place in the EU
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Physical appearance: light yellow powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelman, D-4791 Borchen
- Age at study initiation: males: 56 days; females: 66 days
- Weight at study initiation: males: 144-166 g; females: 139-153 g
- Fasting period before study: 16 hours
- Housing: One animal per cage in Makrolon Type II cages
- Diet (e.g. ad libitum): standard diet (ALTROMIN®)
- Water: Free access to water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 50 - 60
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 237 mg/mL

MAXIMUM DOSE VOLUME APPLIED: 21.5 mL/kg

Doses:
5110 mg/kg
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: Not indicated
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, mortality
Statistics:
Calculation LD50 determined with Probitanalyse (1952) (if required).

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 110 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred during the study.
Clinical signs:
In all animals diarrhoea was observed on the first day (day 1) after application.
Body weight:
No data.
Gross pathology:
No data
Other findings:
None.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified according to Regulation EC 1272/2008
Conclusions:
In an acute oral toxicity study with male and female rats, performed equivalent or similar to OECD 401 guideline, the LD50 was calculated to be >5110 mg/kg.
Executive summary:

In an acute oral toxicity study, performed comparable to OECD test guideline 401, male and female rats were exposed to 5110 mg/kg via gavage. No deaths occurred during the study. In all animals diarrhoea was observed on the first day (day 1) after application. The LD50 was determined to be >5110 mg/kg.