Fatty acids, C18-unsatd.

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

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

Adequacy of study:

key study

Study period:

04 Mar - 11 Mar 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP - Guideline study, tested with the source substance CAS 67701-08-0. 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:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: 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.

EC Number:

266-932-7

EC Name:

Fatty acids, C16-18 and C18-unsatd.

Cas Number:

67701-08-0

IUPAC Name:

67701-08-0

Details on test material:

- Name of test material (as cited in study report): Edenor Ti dest. (FS010)
- Physical state: white wax
- Analytical purity: no data

Test animals / tissue source

Species:

rabbit

Strain:

other: Kleinrussen Chbb:Hm

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Age at study initiation: adults
- Sex: male
- Identification: ear tag and cage signs
- Weight at study initiation: mean 2297.5 g
- Housing: individually in rabbit battery (Heinkel, 7343 Kuchen, Germany)
- Diet (e.g. ad libitum): Altromin-Haltungsdiät 2023 (Altromin GmbH, Lage, Germany); ad libitum
- Water (e.g. ad libitum): tap water; ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): 45 - 55
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of same animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
- Preparation: made liquid by slight heating

Duration of treatment / exposure:

single application

Observation period (in vivo):

3 d

Number of animals or in vitro replicates:

3

Details on study design:

SCORING SYSTEM:
Acc. to 79/831/EWG, Annex V, Part B:
Cornea:
0 – No ulceration or opacity
1 – Scattered or diffuse areas of opacity (other than slight dulling of normal luster), details of iris clearly visible
2 - Easily discernible translucent area; details of iris slightly obscured
3 - Nacreous area; no details of iris visible; size of pupil barely discernible
4 - Opaque cornea; iris not discernible through the opacity

Iris:
0 – Normal
1 - Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia;
or injection; iris reactive to light (a sluggish reaction is considered to be an effect
2 - Haemorrhage, gross destruction, or no reaction to light

Conjunctivae
Erythema
0 – Normal
1 - Some blood vessels hyperaemic (injected)
2 - Diffuse, crimson colour; individual vessels not easily discernible
3 - Diffuse beefy red

Chemosis
0 – Normal
1 - Some swelling above normal
2 - Obvious swelling, with partial eversion of lids
3 - Swelling, with lids about half closed
4 - Swelling, with lids more than half closed


TOOL USED TO ASSESS SCORE: Fluorescein
ca. 24 h prior to application, 0.1 ml of a 0.5 % Fluorescein solution was instilled into the eyes and washed out 20 sec later to detect corneal damage.
24 h after instillation of the test substance, 0.1 ml of a 0.5 % Fluorescein solution was instilled into the eyes and washed out after 20 seconds to detect corneal damage.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: mean 24 - 72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: mean 24 - 72 h

Score:

0

Max. score:

2

Reversibility:

other: no effects

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: mean 24 - 72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible within: 24 h

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: mean 24 - 72 h

Score:

0

Max. score:

4

Reversibility:

not fully reversible within: 6 h

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU