Trimethoxy(2,4,4-trimethylpentyl)silane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

04 March - 29 April 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

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 (incl. QA statement)

Remarks:

FREIE UND HANSESTADT HAMBURG; BEHÖRDE FÜR ARBEIT, GESUNDHEIT UND SOZIALES, Germany

Test material

Test material information

Constituent 1

Reference substance name:

Trimethoxy(2,4,4-trimethylpentyl)silane

EC Number:

251-995-5

EC Name:

Trimethoxy(2,4,4-trimethylpentyl)silane

Cas Number:

34396-03-7

Molecular formula:

C11H26O3Si

IUPAC Name:

trimethoxy(2,4,4-trimethylpentyl)silane

Test animals

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: LPT Laboratory of Pharmacology and Toxicology KG
- Age at study initiation: 3.5-4 months
- Weight at study initiation: 1.9-2.0 kg
- Housing: Individually in cages measuring 425x600x380 mm
- Diet: ssniff K-H (ssniff Spezialdiäten GmbH, Soest, Germany; analysed for contaminants at least twice a year), ad libitum
- Water: tap water (analysed for contaminants at least twice a year), ad libitum
- Acclimation period: At least 20 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 55±15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From 09 April 2002 to 29 April 2002

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 ml

Duration of treatment / exposure:

4 h

Observation period:

96 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: Semi-occlusive

REMOVAL OF TEST SUBSTANCE
- Washing: No

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1 and #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 2

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 96 h

Results 3

Irritation parameter:

edema score

Basis:

mean

Remarks:

over all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

Animals 1 and 2 showed no signs of irritation at any time point. Animal 3 had an erythema (grade 1) from 60 minutes up to 72 hours after patch removal.

Other effects:

There were no other effects reported.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No. 1272/2008

Conclusions:

The test item was tested for skin irritation/corrosion according to the OECD TG 404 and in complinance with GLP. Minor erythema (score 1) was observed in one out of three animals, which was reversible within 96 hours. Hence, the test item was found to be not irritating and classification according to Regulation (EC) No. 1272/2008 is not warranted.