2-Propenoic acid, 2-methyl-, hydroxybutyl ester

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 August - 06 September, 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was conducted according to OECD and in accordance with GLP. The study material is well characterized

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

adapted 17 Dec 2001

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

2004/73/EC

GLP compliance:

yes

Remarks:

2004/9/EC

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Test material form:

liquid

Test animals

Species:

rat

Strain:

other: Sprague-Dawley CD ( Crl® (SD) IGS BR)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK.
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: ±20% of the mean
- Fasting period before study: Overnight
- Housing: Groups of 3 in suspendeed solid-floor polypropylene cages
- Diet : Free access to Certified Rat and Mouse Diet (Code 5LF2) supplied by BCM IPS Ltd, London, UK
- Water: Free acess to mains drinking water
- Acclimation period: 5 days minimum

ENVIRONMENTAL CONDITIONS
- Temperature: 19°C - 25°C
- Humidity: 30% - 70 %
- Air changes (per hr): 15 minimum
- Photoperiod (hrs dark / hrs light): 12hrs continuos light and 12hrs darkness.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Using all available information on the toxicity of the test material, 2000 mg/kg was chosen as the starting dose.
Dose volume; 1.99ml/kgs

Doses:

dose level: 2000 mg/kg

No. of animals per sex per dose:

6 females per dose

Control animals:

no

Details on study design:

All animals were dosed once only by gavage, using a metal cannula attached to a graduated syringe. The volume administered was calculated according to the fasted bodyweight at the time of dosing. Treatment of animals was sequential. Sufficient time was allowed between each group to confirm the survival of the previously dosed animals.

The animals were observed for deaths or overt signs of toxicity 1/2, 1, 2 and 4 hours after the dosing and subsequently once daily for fourteen days.

Individual bodyweights were recorded prior to dosing and seven and fourteen days after treatment.

At the end of the observation period the animals were killed by cervical dislocation. All animals were subjected to gross pathological observations. This consisted of external examination and opening of the abdominal and thoracic cavities for examination of major organs. The appearance of any macroscopic abnormalities were recorded. No tissues were retained.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

other: Signs of systemic toxicity noted during the study were hunched posture, lethargy, increased salivation, pilo-erection, noisy repiration and red/brown staining around the mouth. Animals appeared normal two, three or nine days after dosing.

Gross pathology:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Remarks:

Migrated information

Conclusions:

The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 2500 mg/kg bodyweight (GHS Category 5 >2000 - 5000 mg/kg bodyweight)