12-hydroxystearic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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. 09, 1990 to Oct. 12, 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was 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 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

A lower dose of 0.2 g (versus 0.5 g) was used because of the very low specific weight of the test substance

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: 84/449/ECC

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Castor oil, hydrogenated

EC Number:

232-292-2

EC Name:

Castor oil, hydrogenated

Cas Number:

8001-78-3

IUPAC Name:

8001-78-3

Constituent 2

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 castor oil, hydrogenated
- Physical state: White powder
- Composition of test material, percentage of components: Hydrated fatty acid and ricinus oil

Test animals

Species:

rabbit

Strain:

other: Kleinrussen

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Breeder: Thomas, Biberach/FRG
- Age at study initiation: 21-22 months
- Weight at study initiation: ca. 2860 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: Minimum 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

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.2 g (versus 0.5 g according to the guideline) was used because of the low specific weight of the test substance
- Concentration (if solution): Undiluted

Duration of treatment / exposure:

4 h

Observation period:

24 h after patch removal

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm2 (dorsal)
- Type of wrap if used: Gauze patch was first applied with the test substance. The patch was then covered with an adhesive air- water stream permeable patch. The patch was fixed by using a hypoallergenic adhesive gauze bandage.

SCORING SYSTEM: according to the council directive 84/449/EEC [Off. Journal Europ. Commun. L 251/108, 1984].

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 1208

Time point:

other: 1/24/48/72 h

Score:

0

Remarks on result:

other: None

Results 2

Irritation parameter:

edema score

Basis:

animal: 1208

Time point:

other: 1/24/48/72 h

Score:

0

Remarks on result:

other: None

Results 3

Irritation parameter:

erythema score

Basis:

animal: 1210

Time point:

other: 24 h

Score:

1

Remarks on result:

other: None

Results 4

Irritation parameter:

erythema score

Basis:

animal: 1210

Time point:

other: 1/48/72 h

Score:

0

Remarks on result:

other: None

Results 5

Irritation parameter:

edema score

Basis:

animal: 1210

Time point:

other: 1/24/48/72 h

Score:

0

Remarks on result:

other: None

Results 6

Irritation parameter:

erythema score

Basis:

animal: 1212

Time point:

other: 1/24/48/72 h

Score:

0

Remarks on result:

other: None

Results 7

Irritation parameter:

edema score

Basis:

animal: 1212

Time point:

other: 1/24/48/72 h

Score:

0

Remarks on result:

other: None

Other effects:

Not reported.

Any other information on results incl. tables

None.

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 undiluted test substance was considered to be not irritating to rabbit skin.

Executive summary:

A study was conducted to assess the acute irritation potential of hydrogenated castor oil in rabbit, in accordance with OECD Guideline 404.

Undiluted test substance was applied to the dorsal shaved skin of three rabbits under semi-occlusive conditions for an exposure duration of 4 h.

The symptoms were recorded for a period of 24 h after patch removal.

Only one animal showed slight erythema 24 h after exposure. All the other animals were without any symptoms.

Under the conditions of the study, the undiluted test substance was considered to be not irritating to rabbit skin.