5-ethyl-1,3-dioxane-5-methanol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06 July 1992 -27 Aug 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

4 rabbits used

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

5-ethyl-1,3-dioxane-5-methanol

EC Number:

225-967-8

EC Name:

5-ethyl-1,3-dioxane-5-methanol

Cas Number:

5187-23-5

Molecular formula:

C7H14O3

IUPAC Name:

(5-ethyl-1,3-dioxan-5-yl)methanol

Test material form:

liquid

Specific details on test material used for the study:

Batch 9201; clear / colourless liquid

Test animals / tissue source

Species:

rabbit

Strain:

other: SPF albino

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
Source: Møllegard Breeding Centre ApS, Ejby, DK-4623 Lille Skensved
Age at study initiation: Not detailed
Weight at study initiation: 2.5 - 2.7 kg
Housing: Animals were kept in single PPL cages, 45 x 55 cm, with perforated floor
Diet (e.g. ad libitum): The rabbits had free access to food pellets "Altromin 2123"
Water (e.g. ad libitum): Free access to drinking water acidified with hydrochloric acid, to pH 2.5
Acclimation period: At least one week

ENVIRONMENTAL CONDITIONS
Temperature (°C): 21 ± 3°C
Humidity (%): 55 ± 15%
Air changes (per hr): 10
Photoperiod (hrs dark / hrs light): 12 hours light (from 6h until 18h)

IN-LIFE DATES:
From: 06 July 1992
To: 21 July 1992

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
Amount(s) applied (volume or weight with unit): 0.1 mL (neat test substance).

Duration of treatment / exposure:

Single exposure.

Observation period (in vivo):

14 days (observations made 1, 24, 48, and 72 hours after exposure, and on days 7 and 14).

Number of animals or in vitro replicates:

Four females

Details on study design:

REMOVAL OF TEST SUBSTANCE
Washing (if done): No data
SCORING SYSTEM: Broadly consistent with the system described in OECD test guideline 405
TOOL USED TO ASSESS SCORE: Hand held inspection lamp fitted with white and UV-light and a magnifying glass, and fluorescein.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

(cornea opacity)

Basis:

animal #1

Remarks:

Rabbit No. 5449

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: Day 7 score = 1

Results 2

Irritation parameter:

cornea opacity score

Remarks:

(cornea opacity)

Basis:

animal #2

Remarks:

Rabbit No. 5450

Time point:

24/48/72 h

Score:

1.3

Max. score:

2

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: Day 7 score = 1

Results 3

Irritation parameter:

cornea opacity score

Remarks:

(cornea opacity)

Basis:

animal #3

Remarks:

Rabbit No. 5451

Time point:

24/48/72 h

Score:

1.7

Max. score:

2

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: Day 7 score = 1

Results 4

Irritation parameter:

cornea opacity score

Remarks:

(cornea opacity)

Basis:

animal #4

Remarks:

Rabbit No. 5452

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: Day 7 score = 1

Results 5

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

Rabbit No. 5449

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: No effects noted at any timepoints

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

Rabbit No. 5450

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: No effects noted at any timepoints

Results 7

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

Rabbit No. 5451

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: No effects noted at any timepoints

Results 8

Irritation parameter:

iris score

Basis:

animal #4

Remarks:

Rabbit No. 5452

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Results 9

Irritation parameter:

chemosis score

Remarks:

(oedema of conjunctivae)

Basis:

animal #1

Remarks:

Rabbit No. 5449

Time point:

24/48/72 h

Score:

2.7

Max. score:

3

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: Day 7 score = 1

Results 10

Irritation parameter:

chemosis score

Remarks:

(oedema of conjunctivae)

Basis:

animal #2

Remarks:

Rabbit No. 5450

Time point:

24/48/72 h

Score:

1.7

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 11

Irritation parameter:

chemosis score

Remarks:

(oedema of conjunctivae)

Basis:

animal #3

Remarks:

Rabbit No. 5451

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: Day 7 score = 1

Results 12

Irritation parameter:

chemosis score

Remarks:

(oedema of conjunctivae)

Basis:

animal #4

Remarks:

Rabbit No. 5452

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: Day 7 score = 1

Results 13

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #1

Remarks:

Rabbit No. 5449

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: Day 7 score = 1

Results 14

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #2

Remarks:

Rabbit No. 5450

Time point:

24/48/72 h

Score:

2.3

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 15

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #3

Remarks:

Rabbit No. 5451

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: Day 7 score = 1

Results 16

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #4

Remarks:

Rabbit No. 5452

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: Day 7 score = 1

Irritant / corrosive response data:

At the 1 hour reading slight reactions were observed in the cornea and well defined reactions of the coujunctiva (chemosis, redness and discharge) in all the rabbits. The iris were not affected in any of the rabbits. At the 24 hour reading the reactions of conjucntiva had slightly aggravated and the reactions of conjunctiva were unchanged. At the following 48 and 72 hour readings slight to well defined reactions were observed in the cornea and slight to moderate reactions were observed in the conjunctiva. A slight reaction was observed in the iris of one rabbit at the 48 hour readiug. On day 7 slight reactions were observed in the cornea of all the rabbits and slight reactions were observed in the conjunctiva of three rabbits. In one rabbit the conjunctiva appeared normal.On day 14, the eyes of all 4 rabbits appeared normal.

Other effects:

conjunctival discharge was seen in all aninals at up to 72 hours.

Any other information on results incl. tables

On day 14 the eyes of all rabbits apppeared normal. It was therefore concluded that the eye changes induced by the treatment were reversible, and the study was terminated.

Individual irritation scores

Observation		1h	24h	48h	72h	Mean (24-72h)	7d	14d
Cornea	Opacity	2,1,1,1	2,2,2,2	2,1,2,2	2,1,1,2	1.75	1,1,1,1	0,0,0,0
Iris	Lesion	00,0,0,	0,0,0,0	0,0,0,1	0,0,0,0	0.08	0,0,0,0	0,0,0,0
Conjunctivae	Erythema	3,2,2,3	3,3,3,3	3,2,3,3	3,2,3,3	2.83	1,0,1,1	0,0,0,0
	Chemosis	2,2,2,3	3,2,2,2	3,2,2,2	2,1,2,2	2.08	1,0,1,1	0,0,0,0

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

It was concluded that the test substance CTF should be classified as an eye irritant (Category 2) under CLP.

Executive summary:

A study was performed by Scantox, Denmark, on behalf of Perstorp Polyols, Sweden (subcontracted through Toxicon AB, Sweden), to determine the potential for eye irritation of the test substance CTF. The study was conducted to GLP and according to OECD Test Guideline 405. The test substance was instilled in the eyes of four rabbits, and observations were taken shortly after exposure, and after 24, 48, and 72 hours, and 7 and 14 days. Slight to moderate reactions were seen at 24, 48, and 72 hours, slight reactions were observed at 7 days, and no reactions were seen at 14 days. It was concluded that the test substance CTF should be classified as irritating to eyes under the CLP Regulation.