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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
Study pre-dates test guidelines
Principles of method if other than guideline:
"Standard" LD50 test
GLP compliance:
no
Remarks:
Study pre-dates GLP regulations
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Dimethyl succinate
EC Number:
203-419-9
EC Name:
Dimethyl succinate
Cas Number:
106-65-0
Molecular formula:
C6H10O4
IUPAC Name:
dimethyl succinate
Details on test material:
- Name of test material (as cited in study report): Bernsteinsaurerdimethylester
- Lot/batch No.: E438

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 82 - 115 g
- Fasting period before study: 16 hours
- Diet (e.g. ad libitum): Altromin R rat diet, ad-libitum except for a 16 hour fast prior to dosing and approximately 2 hours after dosing
- Water (e.g. ad libitum): Ad-libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Photoperiod (hrs dark / hrs light): Not reported

IN-LIFE DATES: From: Not reported To: Not reported

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
vegetable oil
Remarks:
sesame oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25%
- Justification for choice of vehicle: Solubility miscibility
- Lot/batch no. (if required): Not reported
- Purity: Not reported
Doses:
4000, 6300, 8000, 10000 and 15000 mg/kg
No. of animals per sex per dose:
10 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations - Frequently following dosing followed by at least daily. Weighing - Weekly
- Necropsy of survivors performed: Not reported
Statistics:
Probit analysis

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
6 892 mg/kg bw
Based on:
test mat.
95% CL:
6 256 - 7 592
Mortality:
4000 mg/kg - 0 / 10 (0%)
6300 mg/kg - 3 /10 (30%)
8000 mg/kg - 8 / 10 (80%)
10000 mg/kg - 10 / 10 (100%)
15000 mg/kg - 10 / 10 (100%)

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The median lethal dose (LD50) of the substance following a single oral dose was determined to be 6892 mg/kg body weight
Executive summary:

The test susbtance was administered as a single dose, by gavage, to groups of 10 female rats. Animals were observed for 14 days following dosing for mortality and clinical signs. The incidence of mortality relative to dose was used to calculate the median lethal dose by probit analysis.

The median lethal dose (LD50) of the substance following a single oral dose was determined to be 6892 mg/kg body weight