Dicyclopentyldimethoxysilane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30.06.1995 to 14.07.1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Dicyclopentyldimethoxysilane

EC Number:

404-370-8

EC Name:

Dicyclopentyldimethoxysilane

Cas Number:

126990-35-0

Molecular formula:

C12H24O2Si

IUPAC Name:

dicyclopentyldimethoxysilane

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.39-2.6 kg
- Housing: Individually in suspended metal cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 49-74
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 30.06.1995 to 14.07.1995

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

3 male

Details on study design:

TEST SITE
- Area of exposure: Dorsal flank
- % coverage: Not specified
- Type of wrap if used: Semi-occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with gentle swobbing
- Time after start of exposure: Four hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

24/48/72 h

Score:

4.8

Max. score:

8

Reversibility:

not fully reversible within: 14 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: Crust formation and desquamation on Days 7 and 14, respectively.

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: Crust formation and desquamation on Days 7 and 14, respectively.

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: Crust formation and desquamation on Days 7 and 14, respectively.

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

Well-defined erythema and slight to moderate oedema was noted at all treated skin sites one hour after patch removal and at the 24, 48 and 72 hour observations. The erythema extended up to 4cm beyond two treatment sites one hour after patch removal. The erythema extended up to 9cm beyond all treatment sites at the 24, 48 and 72 hour observations.

Other effects:

Crust formation was noted at all treated skin sites at the 7 day observation, which prevented the accurate evaluation of erythema at one treated skin site at this time. Desquamation was noted at all treated skin sites 14 days after treatment.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

In a skin irritation study conducted according to OECD Test Guideline 404 and in compliance with GLP, dicyclopentyl(dimethoxy)silane was irritating to the skin of rabbits under semiocclusive conditions based on well-defined erythema and desquamation in all three animals tested, and moderate edema in two of the three animals tested.