Lanolin, acetate

Endpoint summary

Description of key information

Skin irritation:

In vitro studies (corrosion and irritation) were not performed as sufficient in vivo data was available to address the endpoint without further testing. Two in vivo studies, performed in rabbits were available to address the data requirement for skin irritation and corrosion. Although both studies were not performed in line with currents guidelines, the data was considered sufficient to address the classification and labelling of the test material. The studies did not include a recovery period beyond 72 hours, however due to the number of reactions, the low reactions and the evidence of reversibility observed during the short observation period, it is expected that this material is not irritating to skin. Furthermore, corroborating evidence is available in the form of two acute dermal toxicity studies in the rat performed as limit tests with related compounds and a human irritation and skin sensitisation study, where human volunteers (53) were repeatedly dosed with the neat material. The three studies all demonstrated that the test material and the related analogues are not irritating to skin.

Eye irritation:

Two studies were available to evaluate the potential of the test material to cause serious eye damage and irritation. The studies were performed to methods equivalent to the current OECD 405 guidelines with no or minor deviations thought to impact the validity of the studies. Minimal ocular reactions were observed during the course of the two studies, and based on the available information, in line with the current irritation criteria, the test material was determined to be non-irritating to eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Not reported

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.

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.

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

 

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).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

5 May 1970 to 24 June 1970

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Qualifier:

according to guideline

Version / remarks:

Draize "Appraisal of Safety of Chemicals in Foods, Drugs and Cosmetics," published by the Association of Food and Drug Officials of the United States; and the Code of Federal Regulations, Title 21, Part 191.12.

Deviations:

not specified

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

The purpose of the study was to determine the degree and nature of the irritation induced by the agent upon instillation into the eye of the rabbit.

GLP compliance:

no

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

No information available.

Vehicle:

unchanged (no vehicle)

Remarks:

undiluted, the test material was heated to 56 deg C for instillation.

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

24 hours (single treatment and unwashed)

Observation period (in vivo):

Examined and the reaction evaluated at 24h, 48h, and 72h.

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): unwashed
- Time after start of exposure: N/A

SCORING SYSTEM: Draize Scale for grading ocular lesions

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Table 1: Results

Animal No.	Observation	Time after administration
		24 hours	48 hours	72 hours	96 hours	7 days
1	Cornea - opacity	0	0	0	0	0
	Cornea - area	0	0	0	0	0
	Cornea - Score	0
	Iris	0	0	0	0	0
	Iris - score	0
	Conjunctivae - redness	0	0	0	0	0
	Conjunctivae - chemosis	0	0	0	0	0
	Conjunctivae - discharge	0	0	0	0	0
	Conjunctivae - Score	0
2	Cornea - opacity	0	0	0	0	0
	Cornea - area	0	0	0	0	0
	Cornea - Score	0
	Iris	0	0	0	0	0
	Iris - score	0
	Conjunctivae - redness	0	0	0	0	0
	Conjunctivae - chemosis	0	0	0	0	0
	Conjunctivae - discharge	0	0	0	0	0
	Conjunctivae - Score	0
3	Cornea - opacity	0	0	0	0	0
	Cornea - area	0	0	0	0	0
	Cornea - Score	0
	Iris	0	0	0	0	0
	Iris - score	0
	Conjunctivae - redness	1	0	0	0	0
	Conjunctivae - chemosis	1	0	0	0	0
	Conjunctivae - discharge	0	0	0	0	0
	Conjunctivae - Score	4

 

Interpretation of results:

GHS criteria not met

Conclusions:

Non-irritating to the rabbit eye.

Executive summary:

Under the conditions of the study, the undiluted test substance, may be considered non-irritating to the rabbit eye. The elevated temperature to maintain the fluid state, had no apparent detrimental effect upon the eyes.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Justification for classification or non-classification

Based on the available information, the test material is not classified for skin or eye irritation in accordance with Regulation EC 1272/2008 (CLP).