Tetradecanol

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:

1997

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:

Tetradecanol

EC Number:

204-000-3

EC Name:

Tetradecanol

Cas Number:

112-72-1

Molecular formula:

C14H30O

IUPAC Name:

tetradecan-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: 2.67-2.94 kg

- Housing: The animals were housed in suspended metal cages.

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

- Water: Mains water (ad libitum).

- Acclimation period: Minimum of five days.


ENVIRONMENTAL CONDITIONS

- Temperature (°C): 17-20C

- Humidity (%): 43-70

- Air changes (per hr): 15

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

Test system

Vehicle:

other: The test material was ground to a fine powder before use.

Controls:

other: The other eye of each animal was used as a control.

Amount / concentration applied:

TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.1ml

- Concentration (if solution): 46 mg (as measured by gently compacting the required volume into an adapted syringe)

Duration of treatment / exposure:

Single instillation of the test material.

Observation period (in vivo):

Assesment of ocular damage/irritation was made approximately 1 hour, 24, 48 and 72 hours following treatment. Total observation period was 14 days.

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE

- Washing (if done): not rinsed


SCORING SYSTEM: Draize J H (1977) "Dermal and Eye Toxicity tests" modified Kay and Callandra.


TOOL USED TO ASSESS SCORE: Standard optalmoscope.

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:

1

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 14 days

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:

1

Max. score:

2

Reversibility:

fully reversible within: 14 days

Remarks on result:

positive indication of irritation

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

2

Reversibility:

fully reversible within: 14 days

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.66

Max. score:

3

Reversibility:

fully reversible within: 14 days

Remarks on result:

no indication of irritation

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 14 days

Remarks on result:

positive indication of irritation

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.66

Max. score:

3

Reversibility:

fully reversible within: 14 days

Remarks on result:

no indication of irritation

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

no indication of irritation

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.66

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

no indication of irritation

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.66

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Diffuse corneal opacity was noted in 2 treated eyes at the 24, 48, and 72 hour observations. Iridial inflammation was noted in 2 treated eyes at the 24 hour observation and persisted in 1 treated eye at the 48 and 72 hour observations.  Moderate conjunctival irritation was noted in all treated eyes 1 hour after treatment and persisted in 2 treated eyes at the 24 and 48 hour observations. Minimal conjunctival irritation was noted in 1 treated eye at the 24 and 48 hour observations and in 2 treated eyes at the 72 hour and 7 day observation. Overall irritation score: Maximum group mean score 27.3 at 24 hours.

All corneal and iridial scores and scores for conjunctival chemosis were normal by day 7. Conjunctival redness persisted in 2 
rabbits through day 7 but scores were 0 by day 14. The effects were therefore fully reversible.  

Other effects:

Discharge was observed from all treated eyes 1 hour after instillation and persisted in one eye for 48 hours and in another for 72  hours. 

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	0/0/0	0/0/0	2/2/2	2/2/1
24 h	0/1/1	0/1/1	1/2/2	1/2/2
48 h	0/1/1	0/1/0	1/2/2	0/2/2
72 h	0/1/1	0/1/0	0/2/1	0/1/1
Average 24h, 48h, 72h	0/1/1	0/1/0.3	0.7/2/1.7	0.3/1.7/1.7
Reversibility*)	c	c	c	c
Average time (unit) for reversion	Day 14	Day 14	Day 14	Day 14

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

 

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Based on cornea scores of 1 in all animals and conjunctivae redness and chemosis reading of 2 in two of the animals, the test material would be a category 2 irritant according to current guidelines.

Executive summary:

In the eye irritation study, fine powder of test material was applied into the eyes of 3 rabbits. Assesment of ocular damage/irritation was made approximately 1 hour, 24, 48 and 72 hours following treatment. Total observation period was 14 days.

Diffuse corneal opacity was noted in 2 treated eyes at the 24, 48, and 72 hour observations.

Iridial inflammation was noted in 2 treated eyes at the 24 hour observation and persisted in 1 treated eye at the 48 and 72 hour observations.  Moderate conjunctival irritation was noted in all treated eyes 1 hour after treatment and persisted in 2 treated eyes at the 24 and 48 hour observations. Minimal conjunctival irritation was noted in 1 treated eye at the 24 and 48 hour observations and in 2 treated eyes at the 72 hour and 7 day observation. Overall irritation score: Maximum group mean score 27.3 at 24 hours.

All corneal and iridial scores and scores for conjunctival chemosis were normal by day 7. Conjunctival redness persisted in 2 

rabbits through day 7 but scores were 0 by day 14. The effects were therefore fully reversible.