Fatty acids, C16-18, isotridecyl esters

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

08 Apr - 14 Apr 1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given in summarized study report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

; observation period post-treatment: 6 days; only female animals used

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Decyl oleate

EC Number:

222-981-6

EC Name:

Decyl oleate

Cas Number:

3687-46-5

Molecular formula:

C28H54O2

IUPAC Name:

decyl octadec-9-enoate

Details on test material:

- Name of test material (as cited in study report): Oleate de Decyle S
- Analytical purity: no data given
- Code: 10117
- Lot/batch No.: 0609 G

Test animals

Species:

mouse

Strain:

other: NMRI EOPS

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 19-21 g

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

not specified

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 female animals

Control animals:

no

Details on study design:

Assessment of the acute oral toxicity of the test material after administration of a single dose.
Observation of the animals for 6 days post treatment.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: mouse

Mortality:

All animals survived.

Clinical signs:

other: No abnormalities were observed.

Any other information on results incl. tables

Under the experimental conditions of the test chosen, the LD50 was >2000 mg/kg bw in female mice. No mortality occurred.

Therefore the test material does not fulfill the requirements to be classified according to GHS- (1272/2008 EC) or EU-(67/548 EEC) criteria.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU