A mixture of: isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-(n)-dodecylphenol; isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-(n)-tetracosylphenol; isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-5,6-didodecyl-phenol. n=5 or 6

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

04.03. - 03.04.1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted May 12, 1981

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

A mixture of: isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-(n)-dodecylphenol; isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-(n)-tetracosylphenol; isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-5,6-didodecyl-phenol. n=5 or 6

EC Number:

401-680-5

EC Name:

A mixture of: isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-(n)-dodecylphenol; isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-(n)-tetracosylphenol; isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-5,6-didodecyl-phenol. n=5 or 6

Cas Number:

125304-04-3

Molecular formula:

C25 H35 N3 O and C37 H59 N3 O

IUPAC Name:

Reaction mass of 2-(2H-benzotriazol-2-yl)-4-methyl-(n)-dodecylphenol, branched and 2-(2H-benzotriazol-2-yl)-4-methyl-5,6-didodecyl-phenol, branched

Details on test material:

- Appearance: yellow liquid
- Storage condition of test material: room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Füllinsdorf, Switzerland
- Weight at study initiation: 2140 - 2280 g
- Housing: individually in metal cages
- Age at study initiation: approx. 12 - 14 weeks old
- Diet: standard rabbit pellet - Nafag No. 814, ad libitum
- Water: fresh water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 30-70 %
- Photoperiod: 12 hours dark/12 hours light

IN-LIFE DATES: from 04 to 11 March 1986

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The left eye remained untreated and served as a control.

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL

Duration of treatment / exposure:

single instillation

Observation period (in vivo):

7 days; examination of the eyes after 1 hour and 1, 2, 3, 7 days after instillation of the test item.

Number of animals or in vitro replicates:

3 males

Details on study design:

REMOVAL OD TEST SUBSTANCE:
- Washing: no washing performed

SCORING SYSTEM:
According to the grading system given in the OECD guideline 405

TOOL USED TO ASSESS SCORE:
hand-slit lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hrs

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.44

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 7

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Instillation of the test article into the conjunctival sac of three rabbit eyes caused minimal redness in 2/3 animals. The average conjunctivae score for all three animals was 0.44 and reversed back to normal within 7 days. One animal displayed chemosis at the one hour time point, this finding reversed to normal within 24 hours. No other ocular reactions were noted.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the experimental conditions employed the test article induced minimal irritation of the conjunctiva below the threshold of significance, and is therefore classified as non-irritating to the rabbit eye.

Executive summary:

The primary eye irritation potential of the test article was investigated in a GLP compliant study according to OECD test guideline No. 405. The test item was applied by instillation of 0.1 ml into the right eye of each of three young adult New Zealand White rabbits. The left eyes remained untreated and served as controls. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours and 7 days after test item instillation. The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity, iris and chemosis were 0.00 for all three animals. One animal displayed chemosis at the one hour time point, this finding reversed back to normal within 24 hours. The individual mean scores for conjunctival redness were 0.33, 0 and 1, respectively. This effect was reversible and was no longer evident 7 days after treatment. No abnormal findings were observed in the cornea or iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. No clinical signs were observed. Thus, the test item did not induce significant or irreversible damage to the rabbit eye and is regarded as not irritating.