Fatty acids, C16-18 and C18-unsatd., Me esters, distn. residues

Eye irritation

Administrative data

Endpoint:

eye irritation, other

Remarks:

in vivo existing study

Type of information:

experimental study

Remarks:

based on read-across

Adequacy of study:

key study

Study period:

From March 1, 1988 to March 15, 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Justification for type of information:

The main components of the UVCB substance are fatty acids and fatty acid methyl esters. Biodiesel was used to assess the endpoint.

Cross-reference

Reason / purpose for cross-reference:

read-across source

Reference

The substance is not skin and eye irritating

Endpoint conclusion:

no adverse effect observed (not irritating)

Endpoint conclusion:

no adverse effect observed (not irritating)

The substance is not skin and eye irritating.

There is no structural alerts or physical chemical property that can support a risk for respiratory tract. Due to the low vapour pressure of the substance, the inhalatory route is of minimal relevance

No classification for skin irritation is warranted under 67/548/EEC or Regulation 1272/2008.

No classification for eye irritation is warranted under 67/548/EEC or Regulation 1272/2008.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C16-18 and C18-unsatd., Me esters

EC Number:

267-015-4

EC Name:

Fatty acids, C16-18 and C18-unsatd., Me esters

Cas Number:

67762-38-3

Molecular formula:

UVCB substance, not univocal molecular formula available

IUPAC Name:

UVCB substance, no IUPAC name avalilable Chemical name: C16-C18 and C18 unsaturated alkyl carboxylic acids methyl esters

Test material form:

liquid: viscous

Details on test material:

- Main characteristic: liquid yellowish
poorly soluble
- Analytical purity: no data
- Lot/batch No.: no data
- registrated with n° 3714/94

Specific details on test material used for the study:

Fatty acids methyl esters (biodiesel)

Test animals / tissue source

Species:

rabbit

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: other eye

Amount / concentration applied:

single application of 0.1 g

Duration of treatment / exposure:

Single application

Observation period (in vivo):

1,6,24,48,72 hours after application

Number of animals or in vitro replicates:

4

Details on study design:

Approximately 24 hours before the application, the eyes of the rabbits were examined for their state of health. In addition to the visual assessment of the untreated eyes, the rabbits were examined with the aid of a 0.5% aqueous fluorescein sodium solution to determine whether the cornea was intact.
0.1 ml of a 0.5% fluorescein sodium solution was placed in the conjunctival sac of the eyes. 20 seconds later, the so treated eyes were rinsed thoroughly with lukewarm tap water. After that, the examination of the cornea was carried out to determine whether stains had adhered to the cornea. If there is no staining of the cornea, the epithelium is intact.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1h

Score:

ca. 1

Max. score:

4

Reversibility:

fully reversible within: 24h

Results 2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 6h

Score:

ca. 0.75

Max. score:

4

Reversibility:

fully reversible within: 18h

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24 h

Score:

ca. 0

Max. score:

4

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

48 h

Score:

ca. 0

Max. score:

4

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance is not irritating for eyes

Executive summary:

The substance was tested for primary eye irritation on rabbits by a single application of 0.1 g of the undiluited test product and permanent contact. Reaction on the cornea and iris were not observed. The conjunctival reactions were slight (redness) and disappeared within 24 after the apllication.