12-hydroxystearic acid

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

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

Adequacy of study:

weight of evidence

Study period:

From Oct. 22, 1990 to Nov. 05, 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted according to accepted guidelines and GLP

Justification for data waiving:

other:

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

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:

other: Council Directive 84/449/EEC, L 251

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, castor-oil, hydrogenated

EC Number:

263-131-4

EC Name:

Fatty acids, castor-oil, hydrogenated

Cas Number:

61790-39-4

IUPAC Name:

Fatty acids, castor-oil, hydrogenated

Details on test material:

- Name of test material (as cited in study report): Edenor OSSG Oxystearinsäure, also known as 'Fatty acids, castor-oil, hydrogenated'
- Physical state: White powder
- Composition of test material, percentage of components: Hydrated fatty acid and ricinus oil

Test animals / tissue source

Species:

rabbit

Strain:

other: Kleinrussen, Chbb:HM

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Breeder: Thomas, Biberach/FRG
- Age at study initiation: 21-22 months
- Weight at study initiation: ca. 2760 g
- Housing: Single holding cage: Heinkel, 7343, Kuchen/FRG
- Diet (e.g. ad libitum): Ad libitum (Altromin-Haltungsdiät 2023, Altromin GmbH, Lage-FRG=
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Minimim 1 wk

ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 20-25 °C
- Humidity (%): ca. 45-70 %
- Photoperiod (hrs dark / hrs light): 12/12
- Other: Animal identification: Ear tattoos and cage label

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL bumb-volume
- Concentration (if solution): undiluted

Duration of treatment / exposure:

24 h

Observation period (in vivo):

7 d

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, solid rinsing with warm water
- Time after start of exposure: after 24 h of exposure

SCORING SYSTEM: All observations were assessed according to the council directive 84/449/EEC [Off. Journal Europ. Cooun. L 251/112, 1984], see Table 1

TOOL USED TO ASSESS SCORE: Fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

1.5

Reversibility:

fully reversible within: 14 days

Irritant / corrosive response data:

All symptoms were reversible 14 d after application.
The treated eyes were without any lesion on their cornea, and no symptons on the iris were observed at any time during the test.

Other effects:

None

Any other information on results incl. tables

For a summary of all symtoms, see Table 2 under "attached background material".

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the study, the test substance is considerd to be only slightly irritating to eyes of rabbit.

Executive summary:

A study was conducted to determine the acute eye irritation potential of undiluted 'fatty acids, castor-oil, hydrogenated' in accordance with OECD Guideline 405 and Council Directive 84/449/EEC, L 251.

The test substance was applied to the right eye of 3 rabbits at a single dose of 0.1 ml volume for 24 h. The left eye served as a control.

Symptoms were reported for a period of 7 d after application. All observations were assessed according to the Council Directive 84/449/EEC.

Slight to strong erythema and slight chemosis were observed. The reactions disappeared completely 14 d after application. The treated eyes were without any lesions on their cornea and no symptoms on the iris were observed at anytime during the test.

Under the conditions of the study, the test substance is considerd as only slightly irritating to eyes of rabbit.