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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
1991-03-04 to 1991 03-26
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study; well-performed and well-documented

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

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:
6-[3-(C12-C18)-alkenyl(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid
EC Number:
701-162-1
Molecular formula:
C22H37NO4 - C28H49NO4
IUPAC Name:
6-[3-(C12-C18)-alkenyl(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Preliminary study; for each dose levels of 500, 1000 and 2000 mg/kg bw one male and one female rats were used. No significant effects were found.

Results and discussion

Preliminary study:
No effect found
Effect levels
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality found
Clinical signs:
other: Within 24 hours: increased respiration rate, squatting posture, sunken flanks, stilted and uncordinated gait, decreased spantaenous activity, bristling coat
Gross pathology:
No effect

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral toxicity of the registration substance was investigated according to the OECD Guideline 401. At dose of 2000 mg/kg bw no significant effect was found.
Executive summary:

The acute oral toxicity of the registration substance was investigated according to the OECD Guideline 401. At dose of 2000 mg/kg bw no significant effect was found.