1,3-Dioxolane-4-methanol, 2-methyl-2-(2-methylpropyl)-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 22 February to 16 August 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD Test guideline and GLP-compliant study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

[2-methyl-2-(2-methylpropyl)-1,3-dioxolan-4-yl]methanol

EC Number:

692-614-6

Cas Number:

5660-53-7

Molecular formula:

C9H18O3

IUPAC Name:

[2-methyl-2-(2-methylpropyl)-1,3-dioxolan-4-yl]methanol

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): PEX-2 (previous public name of the registered substance)
- Storage condition of test material: at room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Coelhario Prospero, Cesario Lange - SP and Coelhario Natanael Alves Ferreira, Sao Roqsue - SP
- Age at study initiation: 2 to 3 months
- Weight at study initiation: 1.8 to 2.7 kg
- Fasting period before study: approximately 12 hours prior to the test substance administration
- Housing: individually in alvanized metal cages ( 50 x 50 x 50 cm)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 24°C
- Humidity (%): 58 to 66%
- Air changes (per hr): not documented
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 22 February 2011 To: 21 April 2011

Test system

Vehicle:

other: non since the substance was tested undiluted

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.1mL
- Concentration (if solution): 100%

Duration of treatment / exposure:

single instillation

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with deionised water
- Time after start of exposure: 24 hours

SCORING SYSTEM: The eyes were examined at various times after application (1 hours, 24h, 48h, 48h and 72h) for signs of irritation in the iris, cornea (opacity and affected area) and conjonctivae (chemosis and conjunctival redness) according to Draize method (OCDE, 2002)

TOOL USED TO ASSESS SCORE: not documented

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Remarks on result:

probability of weak irritation

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48 h

Score:

1.5

Max. score:

2

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48 h

Score:

2

Max. score:

2

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.7

Max. score:

1

Reversibility:

fully reversible within: 72h

Remarks on result:

probability of weak irritation

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48 h

Score:

1

Max. score:

1

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48 h

Score:

1

Max. score:

1

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Remarks on result:

probability of mild irritation

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48 h

Score:

2.5

Max. score:

3

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48 h

Score:

2.5

Max. score:

3

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.3

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Remarks on result:

probability of moderate irritation

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48 h

Score:

2

Max. score:

3

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48 h

Score:

2

Max. score:

3

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Irritant / corrosive response data:

see details in summary Table 7.3.2.1

Any other information on results incl. tables

Table 7.3.2.1: Individual grading of eye reactions (scores)

Rabbit N°	Time	Opacity	Affected area	Iritis	Conjunctival redness	Chemosis
1	1h	1	-	1	2	3
	24h	1	2	1	2	3
	48h	0	0	1	1	1
	72h	0	0	0	0	0
	Mean*	0.3	-	0.7	1.0	1.3
2	1h	1	-	1	1	3
	24h	2	4	1	2	1
	48h**	1	4	1	3	3
3	1h	1	-	1	2	2
	24h	2	4	1	2	1
	48h**	2	4	1	3	3

* mean values calculated as the mean scores of readings at 24, 48 and 72 hours.

** presence of ulcer

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Remarks:

Migrated information

Conclusions:

The registered substance 2-isobutyl-2-methyl-1,3-dioxolane-4-methanol is severely irritating to eyes according to the criteria of this test.

Executive summary:

An acute eye irritation study was performed with 2-isobutyl-2-methyl-1,3-dioxolane-4-methanol in New Zealand White rabbits according to the OECD 405 Guideline and in compliance with the GLP.

Three male rabbits were employed. The test substance (0.1 mL) was applied undiluted into the left eye of each rabbit. The contralateral eye was used as control. The eyes of the rabbits were then evaluated at various times after application (1, 24, 48 and 72 hours for the first animal tested and 1, 24 and 48 hours for the second and third animals tested) for signs of ocular reactions in the iris, cornea and conjunctivae. Irritation was scored according to the Draize method.

No systemic toxicity or abnormality in body weight gain was detected during the observation period.

In the first animal tested, conjunctivae redness, chemosis and iritis were observed during evaluation of 1, 24 and 48 hours. Opacity was observed at 1 hour of evaluation until 24 hours. On day 3, all ocular effects were reverted. In the second and third animals tested, corneal opacity, iritis, chemosis and conjunctival redness were observed during evaluations of 1, 24 and 48 hours. At 48 hours, corneal ulceration, considered irreversible lesion, was observed and the test was terminated.

In conclusion, 2-isobutyl-2-methyl-1,3-dioxolane-4-methanol requires classification as eye corrosive (Category 1; irreversible effects on the eye) according to the Regulation (EC) 1272/2008 (CLP) and GHS UN criteria.