Triethoxy(3-thiocyanatopropyl)silane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 January 1987 to 19 January 1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

occlusive application (semi-occlusive recommended), temperature of 22 ± 2 °C (20 ± 3 °C recommended)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: 84/449/EEC

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Triethoxy(3-thiocyanatopropyl)silane

EC Number:

252-161-3

EC Name:

Triethoxy(3-thiocyanatopropyl)silane

Cas Number:

34708-08-2

Molecular formula:

C10H21NO3SSi

IUPAC Name:

[3-(cyanosulfanyl)propyl]triethoxysilane

Test animals

Species:

rabbit

Strain:

other: White Russian (Albino)

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: ASTA-Werke AG, D-4800 Bielefeld 14
- Age at study initiation: 5 to 8 months
- Weight at study initiation: 2.20 to 2.45 kg
- Housing: singly in stainless tell cages type ASTA
- Diet: standard diet ad libitum
- Water: ad libitum
- Acclimation period: at least one day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 13 January 1987 To: 30 January 1987

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: one test patch and one untreated control patch was applied to the dorsal area of each animal

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

~6 days (observation times: 1, 24, 48 and 72 hours after patch removal, and 6 days after application)

Number of animals:

3M

Details on study design:

TEST SITE
- Area of exposure: 6.25 cm2
- % coverage: Not specified
- Type of wrap if used: Linen cloth secured by synthetic film glue, with an occlusive bandage wrapped around the trunk

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: no data

SCORING SYSTEM: Draize method (see "Any other information on materials and methods incl. tables")

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 6 days

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 6 days

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 6 days

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Two animals displayed erythema immediately after patch removal. One animal developed erythema 24 hours after patch removal. In all cases, erythema was grade one, except at 24 hours in one of the animals displaying an immediate reaction, when grade 2 erythema was observed. In each case, erythema was still visible at 72 hours, however, not at five days after patch removal.

Grade 1 oedema was seen in one animal 24 hours after patch removal. This was no longer visible 48 hours after patch removal.

Other effects:

There was no evidence of systemic toxicity or mortality throughout the study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In a study conducted according to OECD Test Guideline 404 but not incompliance with GLP (reliability score 2), 0.5 mL of triethoxy(3-cyanatopropyl)silane was slightly irritating (by Draize criteria) to the skin of male rabbits when applied under occlusion for 4 hours. Mean individual 24/48/72-hour erythema scores were 1 to 1.3 (fully reversible within 6 days), with corresponding mean oedema scores of 0 to 0.33 (either no individual findings or, in one animal, fully reversible within 48 hours).