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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Basic data given. Lack of details on test material.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
lack of details on test material
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: A. Tuck and Sons Limited, Battlesbridge, Essex, UK.
- Weight at study initiation: 220-265 g (males), 180-265 (females).
- Fasting period before study: animals were fasted 16-20 h prior to administration.
- Housing: by sex in suspended metal cages (370 x 360 x 180 mm) with mesh floors. A maximum of 5 animals were housed in each cage.
- Diet: Rat Diet (Nottingham University, School of Agriculture, Sutton Bonington, Near Loughborough, Leicestershire, UK), ad libitum.
- Water: tap water, ad libitum.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Air changes (per hr): min. 20
- Photoperiod (hrs dark / hrs light): 10/14

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 500 mg/mL
- Amount of vehicle (if gavage):
Range finder study: 2, 4, 10, 20 and 40 mL/kg bw
Main study: 40 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 40 mL/kg bw
Doses:
Range finder study: 1000, 2000, 5000, 10000 and 20000 mg/kg bw
Main study: 20000 mg/kg bw
No. of animals per sex per dose:
Range finder study: 1
Main study: 5
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Range finder study: after dosing, animals were observed daily for 5 days, or until any evidence of toxicity had subsided, whichever was the longer, and any mortalities were recorded.
Main study: animals were observed 30 min, 1, and 4 h after dosing and once daily thereafter for 14 days. Any mortalities or evidence of overt toxicity were recorded. Body weights of all animals were recorded at Day 0 and at Day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy

Results and discussion

Preliminary study:
No mortality occurred in the range finder study at any of the tested dose levels (1, 2, 5, 10 and 20 mg/kg bw). Clinical signs of toxicity were not reported.
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 20 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
Evidence of overt toxicity was confined to subdued activity and pilar erection within 1 h of dosing. Animals had recovered at 4 h. No further symptoms of toxicity were observed throughout the 14-day observation period, in any of the test animals.
Body weight:
No significant effect on body weight increase was apparent.
Gross pathology:
Gross necropsy of all survivors at termination of the study revealed no abnormal macroscopic lesions.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/ EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
CLP: not classified