Octadecan-1-ol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Octadecan-1-ol

EC Number:

204-017-6

EC Name:

Octadecan-1-ol

Cas Number:

112-92-5

Molecular formula:

CH3(CH2)17OH

IUPAC Name:

octadecan-1-ol

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS

- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK.

- Age at study initiation: 12-16 weeks

- Weight at study initiation: 2.9-3.23kg

- Housing: individually housed in suspended metal cages

- Diet: STANRAB SQC Rabbit Diet, Special Diets Services Ltd, Witham, Essex, UK (ad libitum)

- Water: mains drinking water (ad libitum)

- Acclimation period: minimum of five days


ENVIRONMENTAL CONDITIONS

- Temperature (°C): 17-19

- Air changes (per hr): 15

- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of each animal

Amount / concentration applied:

TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.1ml (ca.82mg)

- Concentration (if solution): undiluted

Duration of treatment / exposure:

The application of the test material was a single instillation followed by no washing. An assessment of the initial pain reaction was made immediately after the administration of the test material, followed by assessment of ocular damage/irritation first at 1 hour.

Observation period (in vivo):

1 hour, 24, 48 and 72 hours.

Number of animals or in vitro replicates:

3 (1M,2F)

Details on study design:

REMOVAL OF TEST SUBSTANCE

- Washing (if done): not rinsed

SCORING SYSTEM: Draize and modified Kay and Callandra.


TOOL USED TO ASSESS SCORE: opthalmoscope

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

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

2

Reversibility:

fully reversible within: 48 hours

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Remarks on result:

no indication of irritation

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Remarks on result:

no indication of irritation

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

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

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

AVERAGE SCORE (24+48+72 hour)
- Cornea: 0, 0, 0.3 (group mean score 0.1)
- Iris: 0, 0, 0.3 (group mean score 0.1)
- Conjunctivae (Redness): 0.3, 0, 1 (group mean score 0.43)
- Conjunctivae (Chemosis): 0, 0, 0.3 (group mean score 0.1)
- Overall irritation score: maximum group mean score 10.0 at 1 hour post instillation. Classified as a mild irritant.

Other effects:

The application of the test material produced diffuse corneal opacity restricted to one treated eye at 24 hours. Iridial inflammation was noted in 2 eyes at 1 hour and one at 24 hours. Minimal to moderate conjunctival irritation was reported at 1 hour with minimal conjunctivitis in 2 eyes at 24 hours. All eyes scored 0 at 48 and 72 hours post instillation.  Residual test material noted around all eyes at the 1 hour observation period.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Cornea	Iris	Conjunctivae	Chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
60 min
24 h	0/0/1	0/0/1	1/0/2	0/0/1
48 h	0/0/0	0/0/0	0/0/1	0/0/0
72 h	0/0/0	0/0/0	0/0/0	0/0/0
Average 24h, 48h, 72h	0/0/0.3	0/0/0.3	0.3/0/1	0/0/0.3
Reversibility*)	c	c	c	c
Average time (unit) for reversion	48 h	48 h	48 h	48 h

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Kalcol 8098 is not an eye irritant according to EU or GHS criteria.

Executive summary:

In an acute eye irritation study, 0.1 ml of test material was applied to one eye of 1 male and 2 female rabbits. The untreated eye was used as a negative control group. The application of the test material was a single instillation followed by no washing. An assessment of the initial pain reaction was made immediately after the administration of the test material, followed by assessment of ocular damage/irritation first at 1 hour, and then at 24, 48 and 72 hours post-application.

The application of the test material produced diffuse corneal opacity restricted to one treated eye at 24 hours. Iridial inflammation was noted in 2 eyes at 1 hour and one at 24 hours. Minimal to moderate conjunctival irritation was reported at 1 hour with minimal conjunctivitis in 2 eyes at 24 hours. All eyes scored 0 at 48 and 72 hours post instillation.  Residual test material noted around all eyes at the 1 hour observation period. The study reports the test material to be not irritating to eyes. The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.