1,2-Benzenedicarboxylic acid, di-C9-11-branched and linear alkyl esters

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

from 1988-05-13 to 1988-05-27

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: Test substance not described in sufficient details. For read-across justification see Section 13.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters

EC Number:

271-094-0

EC Name:

1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters

Cas Number:

68515-51-5

IUPAC Name:

68515-51-5

Details on test material:

0- Name of test material (as cited in study report): Witamol 110
- Substance type: product
- Physical state: liquid
- Analytical purity: no data
- Stability under test conditions: no data
- Storage condition of test material: at room temperature in a glass screw-top bottle
- Other: none

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Interfauna (UK) Limited, Wyton, Huntingdon, Cambridgeshire
- Age at study initiation: approx. 5 - 8 weeks
- Weight at study initiation: 150-158 g (males); 129-146 g (females)
- Fasting period before study: overnight
- Housing: in groups up to five animals by sex in solid-floor polypropylen cages with sawdust bedding
- Diet (e.g. ad libitum): free access to Rat and Mouse Expanded Diet No. 1, supplied by Special Diet Services Limited, Witham, Essex, U.K.
- Water (e.g. ad libitum): free access to mains drinking water
- Acclimation period: minimum of 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 24
- Humidity (%): 48 - 60
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 1988-05-13 To: 1988-05-27

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.06 mL/kg bodyweight

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Deaths and overt signs of toxicity were recorded 1 and 4 hours after dosing and subsequently daily, individual bodyweights were recorded on the day of treatment (day 0) and on days 7 and 14.
- Necropsy of survivors performed: yes, no tissues remained
- Other examinations performed: none

Statistics:

Using the mortality data obtained, an estimate of the acute oral median dose (LD50) of the test material was made. No further details mentioned.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

0/10

Clinical signs:

other: No evidence of systemic toxicity was noted

Gross pathology:

no abnormalities detected

Other findings:

none

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral median lethal dose (LD50) of the test material to the rat was found to be greated than 2000 mg/kg bodyweight.

Executive summary:

The study was performed to determine the acute oral median lethal dose (LD50) of the test material, administered undiluted, in the Sprague-Dawley CFY strain rat. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1981) No. 401 "Acute Oral Toxicity".

A group of ten fasted animals (five males and five females) was given a single oral dose of undiluted test material at a dose level of 2000 mg/kg bodyweight.

There were no deaths. No evidence of systemic toxicity was noted during the study period. All animals showed normal gains in bodyweight during the study period. No abnormalities were noted at necropsy of animals killed at the end of the study.

The LD50 of the test material was considered to be greater than 2000 mg/kg bodyweight.