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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:
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

Constituent 1
Chemical structure
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.

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