Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 15 February 2011 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 404 (Acute Dermal 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

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: PROSPERO, CESARIO Lange-SP
- Age at study initiation: around 3 months
- Weight at study initiation: 1.9 to 2.9 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 23°C
- Humidity (%): 60 to 66%
- Air changes (per hr): not documented
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 15 February 2011 To: 18 February 2011

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: none (substance applied undiluted)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL per animal on a 6 cm2 skin area.
- Concentration (if solution): 100%

Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours after patch removal
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: approximately 6 cm2
- Type of wrap if used: Treated areas were covered with a gauze patch held in place with a non-irritating tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test substance was removed using deionized water
- Time after start of exposure: 4 hours

SCORING SYSTEM:according to Draize scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-48-72h
Score:
0
Max. score:
0
Reversibility:
other: not applicable since no erythema was observed at 24, 48 and 72h
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-48-72h
Score:
0
Max. score:
0
Reversibility:
other: not applicable since no edema was observed at 24, 48 and 72h
Irritant / corrosive response data:
Nor edema nor erythema were seen during the observation period in the treated areas of all rabbits at 1, 24, 48 and 72 hours.

Any other information on results incl. tables

No mortality nor treatment related clinical signs were observed during the observation period.

No effect on body weight gain was reported.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The registered substance 2-isobutyl-2-methyl-1,3-dioxolane-4-methanol is not irritating to skin according to the criteria of this test.
Executive summary:

An acute skin irritation study was performed with 2-isobutyl-2-methyl-1,3-dioxolane-4-methanol in New Zealand White rabbits according to the OECD 404 Guideline and in compliance with the GLP.

Three male rabbits were employed. The test substance (0.5 mL) was applied undiluted to an area of 6 cm2 of the left flank previously shaved and covered with a gauze patch. Adjacent non-treated areas of the right flank were used as control. After 4 hours, residual test substance was removed using deionized water. The animals were observed at 1, 24, 48 and 72 hours after patch removal to assess the signs of erythema and edema according to the Draize method. Additionnal general examinations were performed daily.

No systemic toxicity or abnormality in body weight gain occured during the observation period. No edema or erythema was observed at 1, 24, 48 and 72 hours in any animals. Test was concluded at 72 hours since no reaction was observed.

In conclusion, 2-isobutyl-2-methyl-1,3-dioxolane-4-methanol does not require classification as a skin irritant according to the Regulation (EC) 1272/2008 (CLP) and GHS UN criteria.