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

Skin irritation / corrosion

Administrative data

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.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

202-888-7

EC Name:

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

Cas Number:

100-79-8

Molecular formula:

C6H12O3

IUPAC Name:

(2,2-dimethyl-1,3-dioxolan-4-yl)methanol

Test material form:

liquid

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

Test animals

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.

Test system

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)

Results and discussion

In vivo

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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

Results 5

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

Results 6

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

Any other information on results incl. tables

None

Applicant's summary and conclusion

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.