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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
August 30th, 1983 - September 13th, 1983
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Insufficient for assessment due to reduced animal number. Only 2 male and 2 female animals were used, details on test substance not documented.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
: Only two male and two female animals used, details on test substance not documented
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:


- Physical state: white, solid powder
- Analytical purity: >99%
- Composition of test material, percentage of components: free fatty acids <0.5%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: >6 weeks
- Weight at study initiation: males: 282.5 g; females: 166.0 g
- Fasting period before study: 15 h
- Housing: Makrolon Type III cages
- Diet (e.g. ad libitum): Altromin-Haltungsdiät 1324 ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: > 6 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 50
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
VEHICLE
- Concentration in vehicle: 20%
- Amount of vehicle (if gavage): 1.62 ml - 2.95 ml depending on body weight


MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

Doses:
2000 mg/kg
No. of animals per sex per dose:
2
Control animals:
no
Details on study design:
- Frequency of observations and weighing: evaluation of mortality: twice daily; weighting on days 0, 2, 7 and 14
- Necropsy of survivors performed: yes
- Duration of observation period following administration: 14 d
- Other examinations performed: body weight, macroscopic abnormalities (post mortem)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
None
Clinical signs:
No significant signs of toxicity except for transient rough fur and reduced activity direct after dosing
Body weight:
Normal weight gain after dosing.
Gross pathology:
No macroscopic findings

Any other information on results incl. tables

The limit dose of 2000 mg/kg showed no mortality in male and female rats. Although only 2 animals per sex were tested, the observations do not indicate a toxic effect.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information The acute oral lethal dose was greater than 2000 mg/kg in male and female rats. Criteria used for interpretation of results: EU