Registration Dossier

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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

Irritant / corrosive response data:
see 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.