2,4-dimethyl-6-(1-methyl-pentadecyl)phenol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

03.10. - 19.11.1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline study, GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,4-dimethyl-6-(1-methyl-pentadecyl)phenol

EC Number:

411-220-5

EC Name:

2,4-dimethyl-6-(1-methyl-pentadecyl)phenol

Cas Number:

134701-20-5

Molecular formula:

C24 H42 O

IUPAC Name:

2-(hexadecan-2-yl)-4,6-dimethylphenol

Details on test material:

- Physical properties: liquid
- Storage conditions: room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss
- Weight at study initiation: between 2660 to 2760 g
- Housing: individually in metal cages
- Diet: ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: ad libitum
- Acclimation period: at least 5 days

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

IN-LIFE DATES: From: October 29, 1991 To: November 12, 1991

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The right 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):

Examination of the eyes after 1 hour and 1, 2, 3, 7 days after instillation of the test substance.

Number of animals or in vitro replicates:

3 male NZW rabbits

Details on study design:

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:

other: mean (24+48+72h)

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: mean (24+48+72h)

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: mean (24+48+72h)

Score:

0.89

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: mean (24+48+72h)

Score:

0.11

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

See table 1 below.

Other effects:

None.

Any other information on results incl. tables

Table 1: Eye irritation scores of the test substance

	time	animal 1	animal 2	animal 3
corneal opacity	24 h	0	0	0
	48 h	0	0	0
	72 h	0	0	0
iris	24 h	0	0	1
	48 h	0	0	0
	72 h	0	0	0
conjunctivae	24 h	1	1	1
	48 h	1	1	1
	72 h	0	1	1
chemosis	24 h	0	0	1
	48 h	0	0	0
	72 h	0	0	0

All ocular reactions were reversible within 7 days.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Under the experimental conditions employed the test article, when instilled into the conjunctival sac of albino rabbits' eyes, induced irritation of the conjunctiva below the threshold of significance and does therefore not require classification for eye irritation.

Executive summary:

In an acute eye irritation/corrosion study according to OECD guideline 405 and in compliance with GLP, 0.1 ml of the undiluted test item was instilled into one eye of each of three male New Zealand White rabbits. Observations were made 1, 24, 48, 72 hours and 7 days after instillation. Irritation of the conjunctivae was seen as redness and chemosis, reversible within 7 days. The average scores (24 -72 hours) for each animal were 0.67, 1 and 1 for redness and 0, 0 and 0.33 for chemosis, respectively. Based on these results and according to the EC criteria for classification and labeling requirements the test substance does not need to be classified.