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EC number: 262-979-2 | CAS number: 61788-48-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 7, 1976
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- To determine the effects of the test material when applied to the rabbit's skin designed similar to the Draize procedure as described in 16 CFR 1500.41.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Lanolin, acetate
- EC Number:
- 262-979-2
- EC Name:
- Lanolin, acetate
- Cas Number:
- 61788-48-5
- Molecular formula:
- Variable
- IUPAC Name:
- Lanolin, Acetates
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Not reported
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: The back of each animal was shaved free of hair; intact skin was exposed on the left half of the shaved area, and the abraded on the right half.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL or 0.5 g
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- up to 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: back
- Type of wrap if used: A square patch of surgical gauze measuring 1 inch x 1 inch.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
- Time after start of exposure: N/A
OBSERVATION TIME POINTS
24 and 72 hours
SCORING SYSTEM:
- Method of calculation: Draize scoring Criteria:
- Primary Skin Irritantion Indexes of less than 2.0 are mild irritants.
- Primary Skin Irritantion Indexes of 2.0 to 5.0 are moderate irritants.
- Primary Skin Irritantion Indexes of greater than 5.0 are severe irritants.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- animal #1
- Time point:
- other: 24/72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Remarks:
- Abraded skin
- Basis:
- animal #1
- Time point:
- other: 24/72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- animal #2
- Time point:
- other: 24/72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Remarks:
- Abraded skin
- Basis:
- animal #2
- Time point:
- other: 24/72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Remarks:
- Intact Skin
- Basis:
- animal #3
- Time point:
- other: 24/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Remarks:
- Abraded skin
- Basis:
- animal #3
- Time point:
- other: 24/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- animal #4
- Time point:
- other: 24/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Remarks:
- Abraded skin
- Basis:
- animal #4
- Time point:
- other: 24/72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- animal #5
- Time point:
- other: 24/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Remarks:
- Abraded skin
- Basis:
- animal #5
- Time point:
- other: 24/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- animal #6
- Time point:
- other: 24/72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Remarks:
- Abraded skin
- Basis:
- animal #6
- Time point:
- other: 24/42 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- animal #1
- Time point:
- other: 24/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Remarks:
- Abraded skin
- Basis:
- animal #1
- Time point:
- other: 24/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- animal #2
- Time point:
- other: 24/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Remarks:
- Abraded skin
- Basis:
- animal #2
- Time point:
- other: 24/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- animal #3
- Time point:
- other: 24/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Remarks:
- Abraded skin
- Basis:
- animal #3
- Time point:
- other: 24/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Remarks:
- Intact Skin
- Basis:
- animal #4
- Time point:
- other: 24/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Remarks:
- Abraded skin
- Basis:
- animal #4
- Time point:
- other: 24/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- animal #5
- Time point:
- other: 24/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Remarks:
- Abraded skin
- Basis:
- animal #5
- Time point:
- other: 24/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- animal #6
- Time point:
- other: 24/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Remarks:
- Abraded skin
- Basis:
- animal #6
- Time point:
- other: 24/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- not specified
- Irritant / corrosive response data:
- Erythema was observed in the intact and abraded skin of five animals. Edema was observed in the intact and abraded skin of four animals. Erythema cleared in the intact and abraded skin of one animal, and edema cleared in the intact skin of three animals, and abraded skin of two animals during the 72-hour observation period.
Any other information on results incl. tables
Table 1: Results
Observation |
Test site |
Time (hours) |
Rabbit Number |
|||||
1 |
2 |
3 |
4 |
5 |
6 |
|||
Erythema and Eschar formation |
Intact skin |
24 |
2 |
2 |
1 |
1 |
0 |
1 |
72 |
1 |
1 |
0 |
1 |
0 |
2 |
||
Abraded skin |
24 |
2 |
2 |
1 |
2 |
0 |
1 |
|
72 |
1 |
1 |
0 |
1 |
0 |
2 |
||
Subtotal |
6 |
6 |
2 |
5 |
0 |
6 |
||
Oedema formation |
Intact skin |
24 |
1 |
1 |
0 |
1 |
0 |
0 |
72 |
0 |
0 |
0 |
0 |
0 |
1 |
||
Abraded skin |
24 |
0 |
1 |
0 |
1 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
0 |
1 |
||
Subtotal |
1 |
2 |
0 |
2 |
0 |
2 |
||
Erythema and oedema score |
Subtotal |
7 |
8 |
2 |
7 |
0 |
8 |
|
Primary irritation score |
1.75 |
2 |
1 |
3 |
0 |
2 |
||
Average = 1.62 |
||||||||
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was a mild irritant to the rabbit skin under the conditions of the test. However due to the low response and the reversibility observed in the non-abraded skin, the test material is concluded to be a non-irritant to skin based on the criteria as defined by Regulation EC 1272/2008 (CLP).
- Executive summary:
To skin irritation test was conducted to determine the effects of the test material (adminstered at 0.5 mL or 0.5g for 24 hours and observed at 24 and 72 hours) when applied to the rabbit's skin designed similar to the Draize procedure. The back of 6 rabbits were shaved free of hair; intact skin was exposed on the left half of the shaved area, and the abraded on the right half. Erythema was observed in the intact and abraded skin of five animals. Edema was observed in the intact and abraded skin of four animals. Erythema cleared in the intact and abraded skin of one animal, and edema cleared in the intact skin of three animals, and abraded skin of two animals during the 72-hour observation period. The test substance was a mild irritant to the rabbit skin. However due to the low response and the reversibility observed in the non-abraded skin, the test material is concluded to be a non-irritant to skin based on the criteria as defined by Regulation EC 1272/2008 (CLP).
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