Reaction products of alkenyl dihydrofuran-2,5-dione and polyisoalkenyl dihydro-2,5-furandione with alkylene glycol

Acute Toxicity: oral

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Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 November 2013 to 05 December 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: US Environmental Protection Agency (EPA) Toxic Substances Control Act (TSCA)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Australian Guideline

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:Charles River (UK) Ltd., Margate, Kent, UK.
- Weight: Start of the main study the males weighed 158 to 188g, and the females 139 to 175g
- Age at study initiation: 5 to 8 weeks
- Weight at study initiation: 193.4 to 213.7g
- Fasting period before study: Overnight
- Housing: groups of up to five by sex in solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): With the exception of an overnight fast immediately before dosing and for approximately two hours after dosing, free access to mains drinking water and food (Rat and Mouse Expanded Diet No. 1, Special Diets Services Limited, Witham, Essex, UK)” was allowed throughout the study
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-24 °C
- Humidity (%): 48-66%
- Air changes (per hr):15
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

5 females+ 5 males

Control animals:

no

Details on study design:

The animals were observed for deaths or overt signs of toxicity 1/2, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days.
Individual bodyweights were recorded prior to dosing on Day 0 and on Days 7 and 14.
At the end of the study the animals were killed by cervical dislocation and subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities for examination of major organs. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.

Statistics:

No statistical analysis was performed.

Results and discussion

Preliminary study:

A preliminary study was performed in a single animal at 2000 mg/kg body weight.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No intercurrent deaths occured during the course of the study.

Clinical signs:

No signs of systemic toxicity were noted during the study.

Body weight:

All animals showed expected bodyweight gain during the study.

Gross pathology:

No abnormalities were recorded at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute, oral toxicity of the test material was assessed in accordance with OCED Guideline 401. The acute oral median lethal dose (LD50) of the test material, in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight. As such, the test material does not meet the GHS criteria for classification.

Executive summary:

Guideline

A study was performed to assess the acute oral toxicity of the test material in the Sprague-Dawley CD strain rat. The method followed that in the OECD Guidelines for Testing of Chemicals No. 401 "Acute Oral Toxicity" (adopted 24 February 1987) and Method B1 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC). The method also complies with the requirements of US Environmental Protection Agency (EPA) Toxic Substances Control Act (TSCA) and Australian Toxicology Guidelines.

Method

Following a range-finding study, a group of ten fasted animals (five males and five females) was given a single oral dose of test material as a solution in arachis oil B.P. at a dose level of 2000 mg/kg bodyweight. The animals were observed for fourteen days after the day of dosing and were then killed and subjected to gross pathological examination.

Results

There were no deaths. No signs of systemic toxicity were noted during the study.

All animals showed expected bodyweight gain during the study.

No abnormalities were noted at necropsy.

The acute oral median lethal dose (LD5O) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.