2,2-dimethyl-1,3-dioxolan-4-ylmethanol

Endpoint summary

Description of key information

Skin irritation : Key study OECD 404, V1, 2009 : not irritating to the rabbit skin
Eye irritation : Key study, OECD 405, V1, 2009 : irritating to the rabbit eye.

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:

From 21 July 2009 to 06 November 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study conducted in compliance with OECD Guideline 404 without any deviation.

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Remarks:

19 November 2008

Specific details on test material used for the study:

Name of test material (as cited in study report): PEX-01; 2,2-Dimetil-4-Hidroximetil-1,3-Dioxolano
- Physical state: Clear liquid
- Analytical purity: 99.5%
- pH of test substance = 6
- Composition of test material, percentage of components: 99.9% 2,2-Dimethyl-1,3-dioxolane-4-methanol; water: 0.02%; Acidity (Acetic acid): 0.0021%
- Lot/batch No.: 081001
- Expiration date of the lot/batch: 01 October 2009
- Stability under test conditions: Stable at room temperature and under normal conditions of use
- Storage condition of test material: at room temperature

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Natanael Alves Ferreira
- Age at study initiation: Approximately 3 months
- Weight at study initiation: At least 1.5 kg
- Housing: galvanized metal cages (Gaiolas Ipanema, 50 x 50 x 50 cm)
- Diet: Commercial diet for the species (Guabi, Santa Fé), ad libitum
- Water: filtered water, ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: from 19ºC to 21ºC
- Humidity: 68%
- Air changes: No data
- Photoperiod: 12 h dark / 12 h light

IN-LIFE DATES: From: 24 August 2009 To: 27 August 2009.

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: Non-treated area of the right flank was used as control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (weight with unit): 0.5 mL
- Concentration (if solution): Undiluted test item

Duration of treatment / exposure:

4h

Observation period:

72h

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: Area of approximately 6 cm2 of the left flank of the animals.
- Type of wrap if used: Test item (0.5 mL) was applied to the shaved skin covered with an aluminum foil and gauze patch held in place with a non-irritating tape.

REMOVAL OF TEST SUBSTANCE
- At the end of 4 hours, residual test substance was removed using deionized water.

SCORING SYSTEM: According to the Draize method (OECD, 2002)

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Neither edema nor erythema was observed during the observation period in the treated areas of all rabbits at 24, 48 and 72 hours.

Other effects:

None

None

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the test substance PEX-01 is not classified for skin irritation according to the Regulation (EC) N° 1272-2008 (CLP) and GHS UN.

Executive summary:

In a primary dermal irritation study performed according to OECD Guideline 404 and in compliance with GLP, three male New Zealand White rabbits were dermally exposed to 0.5 mL of undiluted 2,2-Dimethyl-1,3-dioxolane-4-methanol under a semi-occlusive gauze dressing. The test item was applied to the shaved skin under a gauze patch held in place for 4 hours. Animals were observed at 1, 24, 48 and 72 hours after removal of test substance for signs of erythema and edema.

Neither edema nor erythema was observed during the observation period in the treated areas of all rabbits at 24, 48 and 72 hours. In this study, 2,2-Dimethyl-1,3-dioxolane-4-methanolis not a skin irritant on male rabbits.

 

Under the test conditions, the submitted substance 2,2-Dimethyl-1,3-dioxolane-4-methanol is not classified for skin irritation according to the Regulation (EC) N° 1272-2008 (CLP) and GHS UN.

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:

From to 21 July 2009 06 November 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study conducted in compliance with OECD Guideline 405 without major deviation.

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Remarks:

24 February 2009

Specific details on test material used for the study:

Name of test material (as cited in study report): PEX-01; 2,2-Dimetil-4-Hidroximetil-1,3-Dioxolano
- Physical state: Clear liquid
- Analytical purity: 99.5%
- pH of test substance = 6
- Composition of test material, percentage of components: 99.9% 2,2-Dimethyl-1,3-dioxolane-4-methanol; water: 0.02%; Acidity (Acetic acid): 0.0021%
- Lot/batch No.: 081001
- Expiration date of the lot/batch: 01 October 2009
- Stability under test conditions: Stable at room temperature and under normal conditions of use
- Storage condition of test material: at room temperature

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Natanael Alves Ferreira, São Roque - SP
- Age at study initiation: Approximately 3 months
- Weight at study initiation: At least 1.5 kg
- Housing: galvanized metal cages (Gaiolas Ipanema, 50 x 50 x 50 cm)
- Diet: Commercial diet for the species (Guabi, Santa Fé), ad libitum
- Water: filtered water, ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: from 18ºC to 22ºC
- Humidity: 70%
- Air changes: No data
- Photoperiod: 12 h dark / 12 h light

IN-LIFE DATES: From: 08 September 2009 To: 29 September 2009.

Vehicle:

unchanged (no vehicle)

Controls:

other: The right eye, which remained untreated, was used as the negative control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Undiluted test item

Duration of treatment / exposure:

Washing of treated eyes 24 hours following application

Observation period (in vivo):

21 days

Number of animals or in vitro replicates:

3 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: The treated eye of the animals were rinsed after scoring with deionised water 24 hours following application

SCORING SYSTEM: According to the Draize method (OECD, 2002)

TOOL USED TO ASSESS SCORE:
- Observations at 24 hours, 48 hours, 72 hours, 7 days, 14 days and 21 days were performed with the aid of fluorescein to detect possible corneal abnormalities which are not grossly observable. Following an approximate 15 seconds exposure, both eyes were rinsed with water and further observed.

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48h

Remarks on result:

positive indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 21 days

Remarks on result:

positive indication of irritation

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

2

Reversibility:

fully reversible within: 48 hours

Remarks on result:

positive indication of irritation

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.7

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Remarks on result:

positive indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.3

Max. score:

3

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 21 days

Remarks on result:

positive indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

positive indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

positive indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

- Signs of ocular irritation were observed at 1h, 24h, 48h, 72h, 7d and 14d.
- At 1h of observation, all animals presented opacity, conjunctivae redness and chemosis and two animals presented iritis.
- At 24 hours, all animals presented corneal opacity, conjunctival redness, chemosis and iritis. - At 48 hours, two animals presented opacity, iritis and chemosis and all animals presented conjunctivae redness.
- At 72 hours, all animals presented conjunctivae redness, two animals presented opacity and chemosis and one animal presented iritis.
- On day 7, ocular reactions were reverted in one animal, one animal presented chemosis and conjunctivae redness and one animal presented corneal opacity.
- On day 14, one animal presented conjunctivae redness and one animal presented opacity.
- All ocular reactions reverted on day 21.

Other effects:

None

Table 7.3.2/1: Results of eye irritation

Rabbit Nº	Time	Opacity	Area	Iritis	Conjunctival redness	Chemosis
1	1h	1	1	0	2	3
	24h	1	1	1	2	1
	48h	0	0	0	1	0
	72h	0	0	0	1	0
	7d	0	0	0	0	0
	14d	0	0	0	0	0
	21d	0	0	0	0	0
2	1h	1	1	1	2	3
	24h	1	3	1	2	1
	48h	1	2	1	2	1
	72h	1	1	1	2	1
	7d	0	0	0	1	1
	14d	0	0	0	1	0
	21d	0	0	0	0	0
3	1h	1	1	1	2	3
	24h	1	3	1	2	1
	48h	1	3	1	2	1
	72h	1	2	0	2	1
	7d	1	1	0	0	0
	14d	1	1	0	0	0
	21d	0	0	0	0	0

Interpretation of results:

Category 2A (irritating to eyes) based on GHS criteria

Conclusions:

Under the test conditions, PEX-01 is classified as Category 2 (H319: Causes serious eye irritation) according to the Regulation (EC) N° 1272-2008 (CLP) and Category 2A (H319: Causes serious eye irritation) according to GHS UN.

Executive summary:

In an eye irritation study conducted according to the OECD Guideline 405 and in compliance with GLP, 3 healthy male rabbits of the New Zealand White strain were exposed to 0.1 mL of undiluted submitted substance 2,2-Dimethyl-1,3-dioxolane-4-methanol in their left eye while the right eye remained untreated and served as control. The treated eye of the animals was rinsed after scoring with deionised water 24 hours following application. The eyes were examined and the changes were observed at 1, 24, 48 and 72 h and up to Day 21 after treatment and graded according to the Draize method.

 

Mean scores calculated for each animal over 24, 48 and 72 hours were as follows:

. corneal opacity: 0.3, 1 and 1

. iris lesions: 0.3, 1 and 0.7

. redness of the conjunctiva: 1.3, 2 and 2

. chemosis: 0.3, 1 and 1

Signs of ocular irritation were observed at 1h, 24h, 48h, 72h, 7d and 14d. All ocular reactions reverted on day 21. In this study, 2,2-Dimethyl-1,3-dioxolane-4-methanol is an eye irritant on male rabbits.

 

Under the test conditions, 2,2-Dimethyl-1,3-dioxolane-4-methanol is classified as Category 2 (H319: Causes serious eye irritation) according to the Regulation (EC) N° 1272-2008 (CLP) and Categor 2A (Cause serious eye irritation) according to GHS UN.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In a primary dermal irritation study performed according to OECD Guideline 404 and in compliance with the GLP, three male New Zealand White rabbits exposed for 4 hours to 0.5 mL undiluted 2,2-Dimethyl-1,3-dioxolane-4-methanol under a gauze dressing showed no signs of irritation.

In an eye irritation study conducted according to the OECD Guideline 405 and in compliance with the GLP, undiluted 2,2-Dimethyl-1,3-dioxolane-4-methanol induced reversible eye irritation in three male New Zealand White rabbits. Signs of ocular irritation were observed at 1h, 24h, 48h, 72h, 7d and 14d. All ocular reactions reverted on day 21.

Justification for classification or non-classification

As the submission substance is expected to be not irritating to the skin, it is not classified for skin irritation according to the Regulation (EC) N° 1272-2008 (CLP) and GHS UN.

 

As the submission substance is expected to induce reversible effects on the eyes, it is classified as Category 2 (H319: Causes serious eye irritation) according to the Regulation (EC) N° 1272-2008 (CLP) and as Category 2A (H319: Causes serious eye irritation) according to GHS UN.