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

Endpoint summary

Description of key information

Studies of in vivo skin and eye irritation are available for CTF. Studies of in vivo skin and eye irritation are available for CTF.

 

5 -ethyl-1,3 -dioxane-5 -methanol is irritating to the eyes and requires classification in Category 2 according to the CLP Regulation.

5 -ethyl-1,3 -dioxane does not meet the criteria for classification as skin irritant according to the CLP Regulation.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 June 1992 - 27 Aug 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

: animals not fully observed for reversibility of effects

GLP compliance:

yes

Specific details on test material used for the study:

Batch 9201; clear/colourless liquid

Species:

rabbit

Strain:

other: Russian

Details on test animals or test system and environmental conditions:

TEST ANIMALS
Source: Møllegard Breeding Centre ApS, Ekby, DK-4623 Lille Skensved
Age at study initiation: Not reported
Weight at study initiation: 2.3 - 2.5 kg
Housing: Kept in single PPL cages, 45 x 55 cm, with perforated floor
Diet (e.g. ad libitum): Rabbits had free access to feed pellets "Altromin 2123"
Water (e.g. ad libitum): Free access to drinking water acidified to pH 2.5 with hydrochloric acid
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 per day (from 06h to 18h)

IN-LIFE DATES
From: 22 June 1992
To: 26 June 1992

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
Amount(s) applied (volume or weight with unit): about 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

72 hours. Observations made half an hour after removal of the dressings, and also 24, 48, and 72 hours after application of the test substance.

Number of animals:

4

Details on study design:

TEST SITE
Area of exposure: Two patches 2.5 x 2.5 cm on each animal
Type of wrap if used: Gauze patches were secured with a cross of 1 cm wide adhesive tape, and fixed with Scanpor tape, 4.5 cm width, loosely wound round the trunk. The test site was clipped as closely as possible with an electric clipper on the day before the experiment.

REMOVAL OF TEST SUBSTANCE
Washing (if done): Skin was cleaned with soap and lukewarm water after removal of the dressings
Time after start of exposure: 4 hours

SCORING SYSTEM:
Consistent with system described in OECD test guideline 404.

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

Rabbit no. 5684

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

other: Slight erythema present during 72 hours observation period

Remarks on result:

other: Slight erythema seen in one animal from 24 hours onwards, still observed after 72 hours.

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

Rabbit No. 5685

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: No findings noted up to 72 hours

Remarks on result:

other: No indication of erythema

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

Rabbit No. 5686

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: No findings noted up to 72 hours

Remarks on result:

other: No indication of erythema

Irritation parameter:

erythema score

Basis:

animal #4

Remarks:

Rabbit No. 5689

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: No findings up to 72 hours

Remarks on result:

other: No indication of erythema

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

Rabbit No. 5684

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: No findings up to 72 hours

Remarks on result:

other: No indication of Oedema

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

Rabbit No. 5685

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: No findings up to 72 hours

Remarks on result:

other: No indication of Oedema

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

Rabbit No. 5686

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: No findings up to 72 hours

Remarks on result:

other: No indication of Oedema

Irritation parameter:

edema score

Basis:

animal #4

Remarks:

Rabbit No. 5689

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: No findings up to 72 hours

Remarks on result:

other: No indication of Oedema

Irritant / corrosive response data:

Very slight erythema was seen on one rabbit which persisted for the duration of the observation period; no signs of erythema or oedema were seen in any of the other three rabbits.

Other effects:

No other effects reported.

Interpretation of results:

not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

A very mild irritant response was seen in one rabbit: the substance is not classified according to CLP.

Executive summary:

An acute dermal irritation test was performed by Scantox, Denmark on behalf of Perstorp Polyols, Sweden (subcontracted through Toxicon, Sweden), to determine the skin irritant properties of the test substance CTF to rats. The study was conducted to GLP and according to OECD Test Guideline 404. The neat liquid test substance was applied to the skin of four female rabbits for a period of four hours. Observations of the irritant response were made shortly after the removal of the test substance, and 24, 48, and 72 hours after exposure. Very slight erythema was seen on one rabbit which persisted for the duration of the observation period (24 -72 hours); no signs of erythema or oedema were seen in any of the other three rabbits. It was concluded that CTF should not be classified as irritating to skin under the CLP Regulation.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

4 rabbits used

GLP compliance:

yes

Specific details on test material used for the study:

Batch 9201; clear / colourless liquid

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

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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

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

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation / corrosion

In a rabbit study with 5 -ethyl-1,3 -dioxane-5 -methanol conducted according to OECD Test Guideline 404 (Dyring Jacobsen, 1992), very slight erythema was seen on one rabbit which persisted for the duration of the observation period (24 -72 hours); no signs of erythema or oedema were seen in any of the other three treated rabbits. Based on these findings, 5 -ethyl-1,3 -dioxane does not meet the criteria for classification according to the CLP Regulation.

 

Eye irritation 

The eye irritant potential of 5 -ethyl-1,3 -dioxane-5 -methanol was determined in rabbits in a GLP study conducted according to OECD Test Guideline 405 (Dyring Jacobsen, 1992). 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 5 -ethyl-1,3 -dioxane-5 -methanol is irritating to the eyes and requires classification in Category 2 according to the CLP Regulation.

Justification for classification or non-classification

Based on the data available, CTF does not require classification for skin irritation according to the CLP Regulation. Classification for eye irritation in CLP Category 2 is required.