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Toxicological information

Skin irritation / corrosion

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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 guidelineopen allclose all
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)
Qualifier:
according to guideline
Guideline:
other: 84/449/EEC
GLP compliance:
no

Test material

Constituent 1
Chemical structure
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-(triethoxysilyl)propyl thiocyanate

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

Resultsopen allclose all
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
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
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
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
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 hours
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 1-1.3 (fully reversible within 6 days), with corresponding mean oedema scores of 0 (either no individual findings or fully reversible within 48 hours).