Fatty acids, C10-18 and C12-22-unsatd., C14-18 and C16-18-unsatd. alkyl esters

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Glp-study according to OECD test guideline

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 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C10-18 and C12-22-unsatd., C14-18 and C16-18-unsatd. alkyl esters

EC Number:

285-200-8

EC Name:

Fatty acids, C10-18 and C12-22-unsatd., C14-18 and C16-18-unsatd. alkyl esters

Cas Number:

85049-31-6

Molecular formula:

UVCB substance, no molecular formula available.

IUPAC Name:

UVCB substance, no IUPAC name available.

Details on test material:

- Name of test material (as cited in study report): FAME, according SDA group C10-C18 and C12-C22 (Biodiesel, broad band)
- Physical state: yellowish liquid
- Analytical purity: > 96.5%
- Impurities (identity and concentrations):
- Lot/batch No.: ASO 161418
- Expiration date of the lot/batch: 30 November 2010
- Storage condition of test material:
- Other: +6°C +/- 3°C, under inert gas

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Rabbits
Three female albino New Zealand rabbits were supplied by the Elevage de Gárome (Quartier Labaste — F40260 Linxe). They were kept during a minimal 5-day acclimatisation period. During the test, the animals weighed between 2.36 kg and 2.79 kg. At the beginning of the test, these animals were 12 weeks old. They were identified prior to inclusion in the test by means of numbered rings on the edges of their ears.

Housing
Each animal was kept in an individual box installed in conventional air conditioned animal husbanding:
The temperature and relative humidity of the main test were controlled to remain within target ranges of 17 to 23°C and 30 to 70%, respectively.
The rate of air exchange was approximately fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (07.00 to 19.00) and twelve hours darkness.

Food and drink
Drinking water (tap-water from public distribution system) and foodstuff (SDS - C15) were supplied freely.
Microbiological and chemical analyses of the water were carried out once every six months by IPL Sante Environnement Durables — Atlantique (Bordeaux).

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 mL/eye

Duration of treatment / exposure:

72h

Observation period (in vivo):

72h

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48, 72h

Score:

ca. 0.43

Max. score:

2

Reversibility:

fully reversible within: 72 h

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72h

Score:

0.22

Max. score:

1

Reversibility:

fully reversible within: 48h

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In a GLP-study according to OECD test guideline 405, the registered substance induced only slight conjuntivae responses, which reversed completely latest after 72h. Consequently, the substance is consdiered to be not irritating to the eye (according to regulation EC No 1272/2008)..

Executive summary:

The test substance was instilled as supplied, into the eye of 3 New Zealand rabbits at the dose of 0.1 mL. The experimental protocol was established on the basis of the official method as defined in the O.E.C.D. guideline No. 405.

The ocular conjunctivae reactions observed during the study have been slight to moderate and totally reversible in the three animals: a slight to moderate redness noted 1 hour after the test item instillation and totally reversible between days 1 and 3, associated with a slight chemosis noted 1 hour after the test item instillation and totally reversible between days 1 and 2.

In conclusion, the results obtained, under these experimental conditions, enable to conclude that the test substance does not have to be classified according to the criteria for the classification, packaging and labelling of dangerous substances in compliance with the E.E.C. Directives 67/548, 2001/59 and 99/45. No symbol or warning label is required.

In accordance with Regulation EC No 1272/2008, the test item does not have to be classified. No signal word or hazard statement is required.