Fatty acids, C12-18 (even-numbered), 3-methylbutyl esters

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

17 Sep - 01 Oct 2003

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study with acceptable restrictions (analytical purity of test substance not specified).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

analytical purity of test substance not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

analytical purity of test substance not specified

GLP compliance:

yes (incl. QA statement)

Remarks:

The Department of Health of the Government of the United Kingdom

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

163961-32-8

Cas Number:

163961-32-8

IUPAC Name:

163961-32-8

Details on test material:

- Name of test material: only trade name given
- Physical state: pale yellow colored liquid
- Analytical purity: no data
- Storage condition of test material: RT in the dark
- Batch number: AO-267-107

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: at least 200 g (± 20%)
- Fasting period before study: No
- Housing: individually in solid floor polypropylene cages during treatment and in groups of 5 thereafter
- Diet: ad libitum (Certified Mouse and Rat Diets, Code 5LF2, International Product Supplies Limited, UK)
- Water: ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): 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: back and flanks
- % coverage: 10
- Type of wrap if used: surgical gauze fixed with self-adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: cotton wool moisted with distilled water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied: 2.26 mL/kg bw
- Constant volume or concentration used: yes

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: 4 times on day of treatmentand subsequently once daily
- Necropsy of survivors performed: yes
- Other examinations performed: body weight on days 7 and 14.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortalities observed at the highest dose tested

Mortality:

No mortality occurred during the study period.

Clinical signs:

No signs of systemic toxicity and no signs of dermal irritation were observed up to the end of the observation period.

Body weight:

Body weight gain was normal except for one female which showed a body weight loss in the first week but expected body weight gain during the second week.

Gross pathology:

Necropsy 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