Fatty acids, coco, esters with oxybis(propanediol)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, coco, esters with oxybis(propanediol)

EC Number:

288-309-9

EC Name:

Fatty acids, coco, esters with oxybis(propanediol)

Cas Number:

85711-49-5

Molecular formula:

Not possible for UVCB

IUPAC Name:

Fatty acids, coco, esters with oxybis(propanediol)

Test material form:

solid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- lot No. of test material: 80118
- Expiration date of the lot/batch: 2018-10-18
- Purity test date: > 99%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Solubility and stability of the test substance in the solvent/vehicle: Soluble in acetone, alcohol, oil and DMSO

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: InVivos Pte Ltd, Singapore
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: Young adult
- Weight at study initiation: 200 to 300 g
- Housing: OptiMICE Caging Systems for rats
- Diet (e.g. ad libitum): Altromin Maintenance Diet #1324
- Water (e.g. ad libitum): Tap water
- Acclimation period: for at least 5 days before the test was conducted

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22
- Humidity (%): 30 - 70

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal area of each animal’s trunk.
- % coverage: approximately 10 percent of the total surface area
- Type of wrap if used: gauze patch and occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of exposure period, residual test substance was then cleaned carefully with water.
- Time after start of exposure: 24 h

TEST MATERIAL
- Concentration (if solution): 2000 mg/kg bw

Duration of exposure:

24

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No animal died during the study.

Clinical signs:

other: No adverse effect was observed on all the animals during the study.

Gross pathology:

No abnormality was observed on all animals during the necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the condition of this study and based on the Globally Harmonised System of Classification and Labelling of Chemicals (GHS) for acute dermal toxicity hazard categories, the test item – Fatty acids, coco, esters with oxybis(propanediol), is considered as Category 5 or Unclassified, the LD50 value of the test item is more than 2000 mg/kg body weight. Classification as to the CLP Regulation is not justified.