Fatty acids, essential, Et esters

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:

key study

Study period:

June 16th, 2010 - June 30th, 2010

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP - Guideline study, tested with the source substance ethyl linoleate (CAS No. 544-35-4). In accordance to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl linoleate

EC Number:

208-868-4

EC Name:

Ethyl linoleate

Cas Number:

544-35-4

Molecular formula:

C20H36O2

IUPAC Name:

ethyl octadeca-9,12-dienoate

Details on test material:

- Name of test material (as cited in study report): 75% ethyl linoleate
- CAS No. of test material (as cited in study report): 544-35-4
- Physical state: hazy yellow liquid
- Purity: 75% ethyl linoleate
- Impurities: 11% Octadecenoic acid ethylester (Ethyl Oleate), 6% Hexadecanoic acid ethylester, 3% Octadecanoic acid ethylester, 3% Octadecadienoic acid glycerol monoester
- Batch: S300660001
- Storage: at room temperature in the dark
- Stability under storage conditions: stable
- Density: 0.88 mg/L (as determined in testing laboratory)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: approx. 10 weeks old
- Mean Bodyweight at study initiation: Males: 294 g, Females: 205 g. Body weight variation did not exceed +/- 20% of the sex mean.
- Housing: individually in Makrolon cages (MIII type, height 18 cm), containing sterilized sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom).
- Diet: Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
- Water: Free access to tap water.
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 ± 3.0ºC (actual range: 19.9 - 21.5)
- Humidity (%): 40-70% (actual range: 39 - 75%)
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: back skin
- % coverage: approx. 10% of the total body surface (are of approx. 25 cm2 for males and 18 cm2 for females)
- Type of wrap if used: The test substance was held in contact with the skin with a dressing, consisting of a surgical gauze patch, successively covered with aluminum foil and Coban elastic bandage. A piece of Micropore tape was additionally used for fixation of the bandages in females only.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): dressings were removed and the skin cleaned of residual test substance using tap water

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg (2.27 mL/kg) body weight. Dose volume calculated as dose level (g/kg) /density (g/mL).
In order to obtain homogeneity, the test substance (formulations) were heated in a water bath with a maximum temperature of 39.5ºC for a maximum of approximately 10 minutes.

Duration of exposure:

24 hours

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: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15.
- Frequency of weighing: weekly
- Necropsy of survivors performed: yes, at the end of the observation period, all animals were sacrificed by oxygen/carbon dioxide procedure and subjected to necropsy.

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.

Clinical signs:

other: Chromodacryorrhoea was shown by two animals on Day 1. Other clinical signs were not noted in any of the animals. The application site did not display any signs of skin irritation.

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU