acrylic acid, 3-(trimethoxysilyl)propyl ester

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

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

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPP 81-5 (Acute Dermal Irritation)

Version / remarks:

1984

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OTS 798.4470 (Acute Dermal Irritation)

Test guideline 3

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

1

Reference substance name:

-

EC Number:

419-560-6

EC Name:

-

Cas Number:

4369-14-6

Molecular formula:

C9H18O5Si

IUPAC Name:

3-(trimethoxysilyl)propyl prop-2-enoate

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., Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-20 weeks old
- Weight at study initiation: 2.25-2.82 kg
- Housing: Individually
- Diet (e.g. ad libitum): STANRAB SQC Rabbit Diet, ad libitum
- Water (e.g. ad libitum): Mains drinking water, ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-19
- Humidity (%): 50-69
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

Up to 7 days

Number of animals:

3M, 3F

Details on study design:

TEST SITE
- Area of exposure: Dorsal/flank area
- % coverage: 2.5 cm x 2.5 cm
- Type of wrap if used: Surgical adhesive tape wrapped in an elasticated corset

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test item was removed by gentle swabbing with cotton wool soaked in 74% industrial methylated spirits
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
At 1 hour following the removal of the patches and approximately at 24, 48 and 72 hours after patch removal, the test site was examined for primary irritation.

SCORING SYSTEM:
- Method of calculation: Draize system

Results and discussion

In vivo

Results

Results 1

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:

Noting, at this timepoint, crust formation and desquamation were noted at all treated skin sites. These reactions extended up to 6 cm at all treatment sites.

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.67

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks:

Noting, at this timepoint, crust formation and desquamation were noted at all treated skin sites. These reactions extended up to 6 cm at all treatment sites.

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks:

Noting, at this timepoint, crust formation and desquamation were noted at all treated skin sites. These reactions extended up to 6 cm at all treatment sites.

Remarks on result:

positive indication of irritation

Results 4

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks:

Noting, at this timepoint, crust formation and desquamation were noted at all treated skin sites. These reactions extended up to 6 cm at all treatment sites.

Remarks on result:

positive indication of irritation

Results 5

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks:

Noting, at this timepoint, crust formation and desquamation were noted at all treated skin sites. These reactions extended up to 6 cm at all treatment sites.

Remarks on result:

positive indication of irritation

Results 6

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks:

Noting, at this timepoint, crust formation and desquamation were noted at all treated skin sites. These reactions extended up to 6 cm at all treatment sites.

Remarks on result:

positive indication of irritation

Results 7

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3.67

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks:

Noting, at this timepoint, crust formation and desquamation were noted at all treated skin sites. These reactions extended up to 6 cm at all treatment sites.

Remarks on result:

positive indication of irritation

Results 8

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks:

Noting, at this timepoint, crust formation and desquamation were noted at all treated skin sites. These reactions extended up to 6 cm at all treatment sites.

Remarks on result:

positive indication of irritation

Results 9

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3.67

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks:

Noting, at this timepoint, crust formation and desquamation were noted at all treated skin sites. These reactions extended up to 6 cm at all treatment sites.

Remarks on result:

positive indication of irritation

Results 10

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks:

Noting, at this timepoint, crust formation and desquamation were noted at all treated skin sites. These reactions extended up to 6 cm at all treatment sites.

Remarks on result:

probability of weak irritation

Results 11

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks:

Noting, at this timepoint, crust formation and desquamation were noted at all treated skin sites. These reactions extended up to 6 cm at all treatment sites.

Remarks on result:

positive indication of irritation

Results 12

Irritation parameter:

edema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

3.67

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks:

Noting, at this timepoint, crust formation and desquamation were noted at all treated skin sites. These reactions extended up to 6 cm at all treatment sites.

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

Well-defined erythema (all animals) and slight (1 female) to severe oedema (3 animals at 1 hour, 5 animals at 24 hours) were noted in animals at 1 and 24 hours after patch removal. Well-defined (5 aninimals) to severe (1 female) erthema and very slight (one female) or severe (other 5 animals) edema were observed at 48 hours. Very slight (1 female) to severe (1 female) erythema and very slight (1 female) to severe ( 1 male and 1 female) oedema were seen at the 72-hour observation. The erythema extended up to 4 cm beyond all treatment sites at 1 hour after patch removal. The erythema extended up to 6 cm beyond for 5 treatment sites at the 24-hour observation, and 4 treatment sites at the 48-hour and 72-hour observations.

Haemorrhage of the dermal capillaries was noted at 1 treated skin site at 1 hour after patch removal and at the 24, 48 and 72-hour observations. Blanching of the skin around the edge of treatment site was noted at one treated skin site at the 24 and 48-hour observations. Light brown discolouration of the epidermis was noted at two treated skin sites at the 24, 48 and 72-hour observations. Skin reactions noted in all treated skin sites at the 7-day observation were crust formation or desquamation, with these reactions extending up to 6 cm beyond all treatment sites at this timepoint.

Applicant's summary and conclusion

Interpretation of results:

Category 1C (corrosive) based on GHS criteria

Remarks:

Annex VI of Regulation (EC) No. 1272/2008 considers the classification to be Category 1B (corrosive), with this classification implemented for the registered substance.

Conclusions:

In the in vivo skin irritation study, conducted according to EPA OPP 81-5 (Acute Dermal Irritation) and in compliance with GLP, the study authors stated that 3-(trimethoxysilyl)propyl acrylate causes severe skin irritation to rabbit skin following 4-hour semi-occluded dermal application. However, the study reviewer concludes that the test substance causes skin corrosion based on the dermal effects still evident at the day 7 observation timepoint. Annex VI of (EC) No. 1272/2008 considers 3-(trimethoxysilyl)propyl acrylate to be corrosive/]h]]]