1,3-Propanediol, 2-methyl-, reaction products with ethenyltrimethoxysilane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 - 26 Apr 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,3-Propanediol, 2-methyl-, reaction products with ethenyltrimethoxysilane

EC Number:

700-957-0

Cas Number:

1141852-17-6

Molecular formula:

UVCB

IUPAC Name:

1,3-Propanediol, 2-methyl-, reaction products with ethenyltrimethoxysilane

Constituent 2

Reference substance name:

Reaction products of trimethoxy(vinyl)silane and 2-methylpropane-1,3-diol (2:5-6)

IUPAC Name:

Reaction products of trimethoxy(vinyl)silane and 2-methylpropane-1,3-diol (2:5-6)

Details on test material:

- Name of test material (as cited in study report): Y-15866
- Physical state: colourless liquid
- Analytical purity: 72%
- Lot/batch No.: 3710-10
- Expiration date of the lot/batch: 2013-07-16
- Storage condition of test material: at room temperature (20 ± 5 °C) and light-protected
- Other: stability under storage conditions: yes

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories France, L’Arbresle, France and Charles River Deutschland GmbH, Kisslegg, Germany
- Age at study initiation: 20 weeks (male) and 10-13 weeks (females)
- Weight at study initiation: 3815 g (male) and 2290-2314 g (females)
- Housing: animals were housed individually in stainless steel cages equipped with feed hoppers and drinking water bowls.
- Diet: pelleted standard Kliba Nafag 3418 rodent maintenance diet (batch no. 05/10, Provimi Kliba AG, Kaiseraugst, Switzerland), ad libitum. A piece of wood (batch no. 102240, ABEDD® - LAB & VET GmbH, Vienna, Austria) and a haystick 4642 (batch no. 54/09, Provimi Kliba AG, Kaiseraugst, Switzerland) were also provided for each animal.
- Water: community tap water from Füllinsdorf, Switzerland, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 20 Apr 2010 (one female) or 21 Apr 2010 (the male and the second female) To: 26 Apr 2010

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

6 (one male and one female) or 7 days (one female)
Reading time points: 1, 24, 48 and 72 h

Number of animals:

1 male and 2 females

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm on the left flank
- Type of wrap if used: the test substance was placed on a surgical gauze patch, which was held in contact with the skin by means of an adhesive hypoallergenic aerated semiocclusive dressing and a restrainer bandage wrapped around the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing: the skin was flushed with lukewarm tap water.
- Time after start of exposure: 4 h

SCORING SYSTEM: according to the numerical scoring system listed in the Commission Regulation (EC) No. 440/2008, B.4, Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: mean after 24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: mean after 24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

The test item did not elicit any skin reactions at the application site of any animal at any of the observation time points. The individual mean erythema/eschar and edema score for each of the three animals was therefore 0. No staining and no corrosive effects were observed on the treated skin.

Other effects:

No further local or systemic effects were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of an in vivo study, performed according to OECD/EC guidelines, Y-15866 is concluded not to have adverse effects on the skin.

Executive summary:

The skin irritation potential of Y-15866 was investigated in a GLP-conform study according to OECD guideline 404. The undiluted test substance (0.5 mL) was applied for 4 h to the clipped skin of 3 young adult New Zealand White rabbits (1 male and 2 females) under semiocclusive conditions. The scoring of skin reactions (erythema and edema) was performed 1, 24, 48 and 72 h after removal of the dressing. The test item did not elicit any skin reactions at the application site of any animal at any of the observation time points. No signs of systemic toxicity were seen. The mean erythema and edema scores over 24, 48 and 72 h were 0 for all 3 animals.