3,4-dihydroxy-1-[(Z)-octadec-9-enyl]pyrrolidine-2,5-dione

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 November 2008 - 11 December 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study; well documented study report

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Physical state: tan colored solid
- Storage condition of test material: room temperature in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

DMSO

Doses:

1

No. of animals per sex per dose:

5

Control animals:

no

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

mg/kg bw

Remarks on result:

other: no deaths

Mortality:

No deaths

Clinical signs:

other: No sings of systemic toxicity

Gross pathology:

No abnormalities were noted at necropsy

Any other information on results incl. tables

The acute oral median lethal dose (LD₅₀)of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight (Globally Harmonised Classification System - Unclassified

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight (Globally Harmonised Classification System - Unclassified).

Executive summary:

The study was performed to assess the acute oral toxicity of the test material in the Wistar strain rat according to OECD Guideline No 420 and Method B1 Acute Toxicity (Oral) of Commission Directive 2004/73/EC. Following a sighting test at adose level of 2000 mg/kg,an additional four fasted female animals were given a single oral dose of test material, as a suspension in dimethy! sulphoxide, at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy. There were no deaths and no signs of systemic toxicity. All animalsshowed expected gains inbodyweight. No abnormalitieswere noted atnecropsy. The acute oral median lethal dose (LD₅₀)of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight (Globally Harmonised Classification System - Unclassified).