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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:
1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Non-GLP

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Name of test material (as cited in study report): Polyol TP30
- Physical state: clear viscous liquid
- Stability under test conditions: not determined

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River U.K. Limited, Margate, kent, England
- Age at study initiation: 4 - 6 weeks
- Weight at study initiation: 115 - 150 g
- Housing: Groups of 5
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 4.46 ml/kg
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
five
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed soon after dosing and at frequent intervals for the remainder,of Day 1. On
subseguent days the animals were observed once in the morning and again at the end of the experimental day. Clinical signs were recorded at each
observation. Individual bodyweights on days 1, 8 and 15.
- Necropsy of survivors performed: yes
Statistics:
None

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
Signs of reaction to treatment observed in all rats five minutes after dosing were piloerection, abnormal body carriage (hunched posture) and abnormal gait (waddling). Increased salivation was also observed in all male rats and one female. Piloerection was the only clinical siqn to persist from one hour after dosing. Recovery, as judged by external appearance and behaviour, was complete by Day 3.
Body weight:
5/5 males showed expected gains in bodyweight over the study period. In the first and second weeks of the observation period for single female rats slightly low body weight gains were recorded.
Gross pathology:
No abnormalities were noted at necropsy
Other findings:
None

Any other information on results incl. tables

There was no mortality. Signs of reaction to treatment observed in all rats five minutes after dosing were piloerection, abnormal body carriage (hunched posture) and abnormal gait (waddling). Increased salivation was also observed in all male rats and one female. Piloerection was the only clinical siqn to persist from one hour after dosing. Recovery, as judged by external appearance and behaviour, was complete by Day 3. 5/5 males showed expected gains in bodyweight over the study period. In the first and second weeks of the observation period for single female rats slightly low body weight gains were recorded. No abnormalities were noted at necropsy

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
No classification is required according to CLP criteria.
Executive summary:

The acute oral median lethal dose (LD50) of Polyol TP30 in the rat was found to be >5000 mg/kg bw with regard to a limit test according to OECD TG 401. A dose of 5000 mg/kg bw was tolerated without mortalities and gross pathological findings. Effects on weight gain were restricted to single female rats. Clinical observation revealed hunched posture, abnormal gait and piloerection.