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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:
weight of evidence
Study period:
March 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well described summary report. Dose, number of animals (with details), experimental design and observation period are described in the study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
not present at the time of performance.
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Elintaal
- Description: clear, colourless liquid

Test animals

Species:
rat
Strain:
other: Wistar-derived
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: from TNO colony
- Age at study initiation: young adults
- Weight at study initiation: males: 135 - 248 g; females: 153 - 196 g
- Fasting period before study: overnight
- Housing: housed in groups of five animals in screen-bottomed stainless steel cages
- Diet: stock diet ad libitum
- Water: tap water ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 -25
- Humidity (%): no data
- Air changes (per hr): well-ventilated
- Photoperiod (hrs dark / hrs light): no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
DOSE VOLUME APPLIED: 1.25, 2.5, 5.0 and 10.0 mL/kg body weight
No. of animals per sex per dose:
3
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 mL/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
All animals looked quite healthy throughout the observation period.
Gross pathology:
No data

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute oral toxicity with rats, an LD50 >10 mL/kg bw was determined.
Executive summary:

Elintaal was tested in an acute oral toxicity study with male and female rats at 1.25, 2.5, 5.0 and 10.0 mL/kg body weight. No deaths occurred. All animals looked quite healthy throughout the observation period. Based on the results, an LD50 >10 mL/kg bodyweight was determined.