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Toxicological information

Skin irritation / corrosion

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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-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
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
Qualifier:
according to
Guideline:
other: 84/449/ECC
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 1208
Time point:
other: 1/24/48/72 h
Score:
0
Remarks on result:
other: None
Irritation parameter:
edema score
Basis:
animal: 1208
Time point:
other: 1/24/48/72 h
Score:
0
Remarks on result:
other: None
Irritation parameter:
erythema score
Basis:
animal: 1210
Time point:
other: 24 h
Score:
1
Remarks on result:
other: None
Irritation parameter:
erythema score
Basis:
animal: 1210
Time point:
other: 1/48/72 h
Score:
0
Remarks on result:
other: None
Irritation parameter:
edema score
Basis:
animal: 1210
Time point:
other: 1/24/48/72 h
Score:
0
Remarks on result:
other: None
Irritation parameter:
erythema score
Basis:
animal: 1212
Time point:
other: 1/24/48/72 h
Score:
0
Remarks on result:
other: None
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.