Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1987-12-17 to 1988-02-08
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Equivalent or similar to OECD guideline 401. No GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1981
Deviations:
not specified
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: colourless liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. Thomae GmbH; D-7950 Biberach; Germany
- Weight at study initiation: Males: 189 g; Females: 180 g
- Fasting period before study: about 16 hours
- Housing: Stainless steel wire mesh cages; type DK-III (Becker Co., Castrop-Rauxel, Germany)
- Diet: Kliba Labordiät 343, Klingentalmühle AG, CH-4303 Kaiseraugst, Switzerland, ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12 (6 .00 - 18 .00 hours/18 .00 - 6 .00 hours )

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: olive oil
Details on oral exposure:
FASTING PERIOD
- Animals were given no feed about 16 hours before administration, but water was available at libitum

VEHICLE
- Test substance formulation with: olive oil
- Concentration in vehicle: 50 (w/v)
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: test substance is insoluble in water

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg


Doses:
5000 mg/kg
No. of animals per sex per dose:
10 (5 males/5 females) per dose
Control animals:
no
Details on study design:
- Time of day of observation: in the morning
- Duration of observation period following administration: 18 days
- Frequency of observations and weighing: observation: daily; weighing: day 0, 6 and 13
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathological examination
Statistics:
NA

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities
Clinical signs:
No clinical signs
Body weight:
No abnormalities
Gross pathology:
No abnormalities

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information