Butanedioic acid, 2,3-dihydroxy- [R-(R*,R*)]-,C12-13-branched alkyl esters

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

2017

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:

Butanedioic acid, 2,3-dihydroxy- [R-(R*,R*)]-,C12-13-branched alkyl esters

EC Number:

947-004-7

Molecular formula:

C28H56O6 - C29H58O6 - C30H60O6

IUPAC Name:

Butanedioic acid, 2,3-dihydroxy- [R-(R*,R*)]-,C12-13-branched alkyl esters

Test material form:

liquid

Details on test material:

product

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Morini - S. Polo d'Enza (RE), Italy
- Age at study initiation: no data
- Weight at study initiation: 190 - 220 g
- Fasting period before study: not mentioned
- Housing: in groups of 5 per sex per cage (polycarbonate, dimensions 425x266x180 mm)
- Diet (e.g. ad libitum): standard pellet complete diet ad libitum
- Water (e.g. ad libitum): filtered tap water ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C +- 2 °C
- Humidity (%): 55 +- 15 %
- Air changes (per hr): 25
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 02-June-1992 To: 16-06-1992

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other:

Remarks:

(sesame seed oil)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 500 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Lot/batch no. (if required): no data
- Purity: no data

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

5000 mg/kg bw administered by stomach tube

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:
Mortality: every morning in the working week (5 out of 7 days)
Clinical symptoms (including evaluation of organic bodys functions, tegumentary apparatus, mucosae conditions, somatomotor activity and sensorium conditions): daily
Body weight: before the experiment, at day 7 and 14
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

No clinical signs

Body weight:

Body weight gain was normal.

Gross pathology:

No effects on organs were found.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 in rats of Butanedioic acid, 2,3-dihydroxy-[R-(R*, R*)]-, C12-13-branched alkyl esters was greater than 5000 mg/kg bw.

Executive summary:

An acute oral toxicity test was carried out on a group of 10 rats (5 male and 5 female) using test material according to OECD guideline 401. The test material Butanedioic acid, 2,3-dihydroxy-[R-(R*, R*)]-, C12-13-branched alkyl esters was administered at a dose of 5000 mg/kg by using a stomach tube. There were no cases of mortality and no toxicological signs during the study. The LD50 was greater than 5000 mg/kg bw and the test material was found to be non-toxic under experimental conditions.