Sodium undec-10-enoate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21/03/2018

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Sodium undec-10-enoate

EC Number:

222-264-8

EC Name:

Sodium undec-10-enoate

Cas Number:

3398-33-2

Molecular formula:

C11H20O2.Na

IUPAC Name:

sodium undec-10-enoate

Specific details on test material used for the study:

sodium undec-10-enoate in a 33.2% aqueous solution administered at 2000mg/kg corresponds to 664 mg/kg of pure sodium undec-10-enoate.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

5 males and 5 females

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The test substance was applied in its original form at a dose level of 2000 mg/kg taking into consideration that the specific gravity of the test substance was 1.032 and directly to the skin of 10 Sprague-Dawley rats (5 males and 5 females). The test substance was held in contact with the skin by means of a semi-occlusive dressing for 24h.

Duration of exposure:

24 hours

Doses:

The administration was performed with the test substance in its original form (sodium undec-10-enoate in a 33.2% aqueous solution) at a dose level of 2000 mg/kg (corresponds to 664 mg/kg of pure sodium undec-10-enoate)

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

the mortality, general behaviour and bodyweight gain of the animals were observed for a period of 14 days after the single application of the test substance . A necropsy was performed on each animal found dead during the study at the end of the study.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 664 mg/kg bw

Mortality:

There was a 20% mortality rate at the dose level of 2000 mg/kg. It appeared on D2 (2females). No apparent signs were observed prior to death which was possibly to experimental stress caused by the dressing.

Gross pathology:

The macroscopic examination revealed no abnormalities in the animals found dead during the study or sacrificed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

sodium undec-10-enoate (in a 33.2% aqueous solution) administed by dermal route in the Rat was higher than 2000mg/kg, i.e. higher than 664 mg/kg of pure sodium undec-10-enoate. A 20% mortaliry was observed at this dose level.

Executive summary:

The acute dermal toxicity study was performed according to the OECD 402 guideline. -

The substance sodium undec-10-enoate (in a 33.2% aqueous solution) administed by dermal route in the Rat was higher than 2000mg/kg, i.e. higher than 664 mg/kg of pure sodium undec-10-enoate. A 20% mortaliry was observed at this dose level.