Lanolin, acetate

Eye irritation

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1970

Report date:

1970

Materials and methods

Test guideline

Test guideline 1

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

Test guideline 2

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

Test material

Test material information

Constituent 1

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

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

No information available.

Test system

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

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 10

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Results 11

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

Results 12

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

Any other information on results incl. tables

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

 

Applicant's summary and conclusion

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.