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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:
key study
Study period:
from 1988-05-13 to 1988-05-27
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test substance not described in sufficient details.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- 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 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:
No evidence of systemic toxicity was noted
Body weight:
normal gains in body weight over the study period
Gross pathology:
no abnormalities detected
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
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 greater than 2000 mg/kg bodyweight.
Executive summary:

The study was performed to determine the acute oral median lethal dose (LD50) of 1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters, 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.