Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September 4th through 18th, 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed to according to GLP and internationally accepted test guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): dipentaerythritol
- Substance type: white powder
- Physical state: solid
- Analytical purity: 96.2%
- Purity test date: received 2-sept-1991
- Lot/batch No.: 9404
- Expiration date of the lot/batch: 2-11-1992
- Storage condition of test material: room temperature in the dark

Test animals

Species:
rat
Strain:
other: Sprague-Dawley origin Crl.CD(SD)BR VAF plus
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River U.K. Limited, Margate, Kent, England
- Age at study initiation: four to seven weeks
- Weight at study initiation: 116-134 g
- Fasting period before study: overnight and 4 hours after dosing
- Housing:The rats were allocated without conscious bias to cages within the treatment group. They were housed in groups of up to five rats of the same sex in metal cages with wire mesh floors in Building R14 Room 6.
- Diet (e.g. ad libitum): A standard laboratory rodent diet (Biosure LAD 1) were provided ad libitum
- Water: ad libitum
- Acclimation period:7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23°C
- Humidity (%): 60%
- Air changes (per hr): 10 to 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 04 September 1991 To: 18 September 1991.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20% w/v in distilled water

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw
Doses:
2.0g/kg bw
No. of animals per sex per dose:
5 rats/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed for clinical signs daily; bodyweights recorded on day 1, day 8, and day 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
Statistics were not performed

Results and discussion

Preliminary study:
No preliminary study was reported.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No deaths at the limit dose
Mortality:
There were no deaths following a single oral dose of dipentaerythritol at 2.0 g/kg bodyweight.
Clinical signs:
Piloerection and abnormal body carriage (hunched posture) were observed in all rats within five minutes of dosing and throughout the remainder of Day 1. There were no other clinical signs and recovery, as judged by external appearance and behaviour, was complete by Day 2.
Body weight:
Slightly low bodyweight gains were recorded for three males on Day 8; these animals achieved anticipated gains on Day 15. All other rats achieved anticipated bodyweight gains throughout the study.
Gross pathology:
No macroscopic abnormalties were observed for animals killed on Day 15.
Other findings:
No other findings reported.

Any other information on results incl. tables

No additional information.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is of low acute toxicity. The acute oral LD50 of dipentaerythritol to rats was > 2000 mg/kg bw under the conditions of this study. Classification is not required.
Executive summary:

A study was performed to assess the acute oral toxicity of dipentaerythritol to the rat. The method followed was that described in EEC Methods for the determination of toxicity, Directive 84/449/EEC (OJ No. L251, 19.9.84), Part B, Method B.1. Acute toxicity (oral).

A group of ten fasted rats (five males and five females) was given a single dose by gavage of the test substance, formulated in distilled water, at a dose level of 2.0 g/kg bodyweight. All animals were killed and examined macroscopically on Day 15, the end of the observation period.

There were no deaths. Clinical signs of reaction to treatment were limited to piloerection and abnormal body carriage and recovery was complete by Day 2. Slightly low bodyweight gains were recorded for three males on Day 8; these rats achieved anticipated gains on Day 15. All other rats achieved anticipated bodyweight gains throughout the study. No abnormalities were recorded at the macroscopic examination on Day 15.

The acute lethal oral dose to rats of dipentaerythritol was found to be greater than 2.0 g/kg bodyweight under the conditions of this study. Dipentaerythritol is not classified for acute oral toxicity according to the CLP Regulation.