Fatty acids, C18-unsatd., mono- and diesters with neopentylglycol and di-and triesters with trimethylolpropane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

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

Adequacy of study:

weight of evidence

Study period:

17 Sep - 01 Oct 2003

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP-Guideline study with acceptable restrictions (no data on analytical purity available)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

adopted in 1987

Deviations:

yes

Remarks:

no data on analytical purity

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

adopted in 1992

Deviations:

yes

Remarks:

no data on analytical purity

GLP compliance:

yes

Remarks:

Department of health of the government of the United Kingdom, UK

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C16-18 and C18-unsatd., branched and linear, esters with trimethylolpropane

Cas Number:

403507-18-6

Molecular formula:

not applicable, substance is a UVCB

IUPAC Name:

Fatty acids, C16-18 and C18-unsatd., branched and linear, esters with trimethylolpropane

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Physical state: pale yellow slightly viscous liquid
- Analytical purity: no data
- Storage condition of test material: room temperature in the dark

Test animals

Species:

rat

Strain:

other: Sprague-Dawley CD (Crl: CD IGS® BR)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Ltd, Margate, Kent, UK
- Age at study initiation: 12 weeks
- Weight at study initiation: 221 – 248 (male) and 202 – 216 (female)
- Housing: 5 animals of the same sex per cage in suspended solid-floor polypropylene cages furnished with woodflakes (except during the 24-h exposure period where the animals were housed individually)
- Diet: certified Rat and Mouse diet (Code 5LF2) (supplied by International Product Supplies Limited, Wellingborough, Northants, UK), ad libitum
- Water: mains water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):19-25
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: clipped skin of back and flanks
- % coverage: 10%
- Type of wrap if used: The treated skin was covered with of surgical gauze which was covered, held in place with self-adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material was removed with cotton wool moistened with distilled water.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.11 mL/kg bw

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for mortality or evident signs of toxicity ½, 1, 2, and 4 hours after dosing and subsequently once daily for 14 days. After removal of the dressing and subsequently once daily for fourteen days, the test sites were examined for evidence of primary irritation and scored according to the Draize score method. Individual body weights were recorded prior to application of the test material on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, and grosspathology.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: No clinical signs of toxicology were observed up to the end of the 14-day observation period.

Gross pathology:

Necropsy examination revealed no substance-related findings.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified