Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well conducted GLP compliant study to international test guidelines

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Diethyl 4-oxopentane-1,2-dicarboxylate
EC Number:
413-860-0
EC Name:
Diethyl 4-oxopentane-1,2-dicarboxylate
Cas Number:
1187-74-2
Molecular formula:
C11H18O5
IUPAC Name:
1,4-diethyl 2-(2-oxopropyl)butanedioate
Details on test material:
- Name of test material (as cited in study report): diethyl-acetonyl-succinate (DAS)
- Storage condition of test material: Room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld, BRD
- Age at study initiation: 6 weeks
- Weight at study initiation: 178-201 g (males; 140-156 g (females)
- Fasting period before study: Overnight
- Housing: Makrolon Type III; 5 animals/cage
- Diet (e.g. ad libitum): Altromin 1324 standard pelleted rodent diet
- Water (e.g. ad libitum): Municipal supply, ad libitum
- Acclimation period: At least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2°C
- Humidity (%): 55±10%
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 1988-09-21 To: 1988-10-05

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/L
- Amount of vehicle (if gavage): 10 mL/kg



MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg


Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
5 male/5 female
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations: at intervals on day of dosing and twice daily thereafter; weighing: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Clinical signs, body weight, food consumption, necropsy
Statistics:
t-test

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Sex:
female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occurred
Clinical signs:
other: No clinical signs observed
Gross pathology:
No macroscopic lesions observed
Other findings:
- Other observations: Food consumption unremarkable

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The median lethal dose (LD50) of the substance following administration of a single oral dose is in excess of 2000 mg/kg
Executive summary:

The median lethal dose (LD50) of the substance following administration of a single oral dose is in excess of 2000 mg/kg