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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Acute Toxicity: oral

Currently viewing:

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:
other: Experimental data reporetd in peer reviewed journal

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2001

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
Study date preceeds implementation of GLP regulations
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Malic acid
EC Number:
230-022-8
EC Name:
Malic acid
Cas Number:
6915-15-7
Molecular formula:
C4H6O5
IUPAC Name:
2-hydroxybutanedioic acid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
No data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25%
- Amount of vehicle (if gavage): No data

MAXIMUM DOSE VOLUME APPLIED: No data

Doses:
No data
No. of animals per sex per dose:
5 male / 5 female
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: No data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 500 mg/kg bw
Based on:
test mat.
Mortality:
No data
Clinical signs:
other: Ataxia, prostration, convulsions and death
Gross pathology:
No data

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 in the rat is reported to be 3500 mg/kg body weight
Executive summary:

The acute oral LD50 in the rat is reported to be 3500 mg/kg body weight