Poly[oxy(methyl-1,2-ethanediyl)], α,α'-(2,2-dimethyl-1,3-propanediyl)bis[ω-hydroxy-]

Acute Toxicity: oral

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Propylidynetrimethanol, ethoxylated

EC Number:

500-110-3

EC Name:

Propylidynetrimethanol, ethoxylated

Cas Number:

50586-59-9

Molecular formula:

C3H5(CH2O(C2H4O)xH) sum of x; >1 - <6.5 mol EO

IUPAC Name:

Propylidynetrimethanol, ethoxylated

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 or test system 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:

other: 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 wa

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.