Registration Dossier

Administrative data

Description of key information

The key study for skin irritation found very slight irritant effects to the skin of rabbit, below the EU threshold for classification (Asta-Werke AG, 1987). The study was conducted according to OECD 404 and in compliance with GLP.  

The key eye irritation study was conducted according to OECD 405 and in compliance with GLP and found the test material to be a non-irritant when applied undiluted to the eyes of rabbits (Asta-Werke AG, 1987).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
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
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
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:
3 males
Details on study design:
TEST SITE
- Area of exposure: 6.25 cm2
- % coverage: no data
- 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")
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.
Interpretation of results:
GHS criteria not met
Conclusions:
In a study carried out according to OECD Test Guideline 404, (triethoxy(3-cyanatopropyl)silane) was slightly irritating (by Draize criteria) to the skin of rabbits when applied under occlusion for 4 hours, with an overall irritation index of 1.1.
Executive summary:

In a study carried out according to OECD Test Guideline 404, (triethoxy(3-cyanatopropyl)silane) was tested for its skin irritation potential in rabbits.

 

0.5 ml of undiluted test substance was applied under occlusion to the shaved skin of three male rabbits for 4 hours. Patches not containing the test substance were also applied to the skin of the same three males to act as concurrent control regions. Rabbits were then observed at 1, 24, 48 and 72 hours after patch removal, and 6 days after application. Skin reactions were graded according to the Draize system.

 

Very slight erythema was observed in all test animals, starting within 24 hours of patch removal (in two animals, an immediate reaction was observed). In one rabbit, erythema became well-defined at 24 hours, and was accompanied by very slight oedema. Oedema was not seen in any other animal, or at any other time point. All signs of irritation were fully reversible within 6 days of application. There were no signs of systemic toxicity or mortality throughout the study.

Triethoxy(3-cyanatopropyl)silane was judged to be slightly irritating according to Draize criteria (i.e. an irritation index between 0.6 and 3.0), based on an irritation index of approximately 1.1, calculated from the sum of mean scores for erythema (1.0) and oedema (0.8). On the basis of this test the test substance would not be classified as irritating according to EU criteria.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 January 1987 to 29 January 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
temperature of 22 ± 2 °C (20 ± 3 °C recommended).
Qualifier:
according to guideline
Guideline:
other: 84/449/EEC
GLP compliance:
no
Species:
rabbit
Strain:
other: White Russian (Albino)
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: ASTA-Werke AG, D-4800 Bielefeld 14
- Age at study initiation: 6 to 7 months
- Weight at study initiation: 2.40 to 2.85 g
- Housing: singly in stainless steel 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: 20 January 1987 To: 23 January 1987
Vehicle:
unchanged (no vehicle)
Controls:
other: one eye of each animal left untreated
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
3 days
Observation period (in vivo):
3 days (at 1, 24, 48 and 72 hours after application)
Number of animals or in vitro replicates:
1 male, 2 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

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

TOOL USED TO ASSESS SCORE: Cliptrix pencil light
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
sum of evaluation scores for three eye sections - mean over all timepoints
Score:
2
Max. score:
110
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: See "Any other information on materials and methods incl. tables" for information on derivation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.66
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis 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:
No observable effects on the cornea or iris were observed.
Hyperaemia or redness (grade 1 or 2) was seen in the conjunctiva at 1 and 24 h after application. This was resolved within two days of application.
Slight swelling (grade 1) or swelling with partial eversion of lids (grade 2) each occurred in one animal within one hour of treatment and resolved within 24 hours.
Slight discharge was noted in one animal within one hour of application only.
Other effects:
There were no overt signs of systemic toxicity or mortality over the duration of the study.
Interpretation of results:
GHS criteria not met
Conclusions:
In a study carried out to OECD Test Guideline 405, (triethoxy(3-thiocyanatopropyl)silane) was non-irritating when applied undiluted to the eyes of rabbits.
Executive summary:

In a study carried out in accordance with OECD Test Guideline 405, (triethoxy(3-thiocyanatopropyl)silane) was tested for its potential to cause eye irritation in rabbits.

0.1 ml of the undiluted test material was applied to one eye of each of three rabbits (two males and one female), with the other eye left as an untreated control. Observations were made 1, 24, 48 and 72 hours after application.

 

There were no overt signs of systemic toxicity or mortality throughout the course of the study. Application of the test substance had no apparent effect on the cornea or iris. Conjunctival redness and hyperaemia was observed in all treated animals within 24 hours, and was fully resolved within 48 hours. Slight swelling and discharge were seen in the treated eye of one animal, and swelling with partial eversion of lids was seen in another. These effects were only evident during the first 24 hours following application.

 

An overall irritation index of 2 was calculated and the test material was considered to be non-irritation to eyes (according to Draize criteria) under the conditions of the test. It would not be classified as an eye irritant by EU criteria.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The key skin irritation study was conducted according to OECD 404 and in compliance with GLP (Asta-Werke AG, 1987). The test material was noted to be slightly irritating to rabbit skin following occlusive application. Very slight erythema was observed in all test animals, starting within 24 hours of patch removal (in two animals, an immediate reaction was observed). In one rabbit, erythema became well-defined at 24 hours, and was accompanied by very slight oedema. Oedema was not seen in any other animal, or at any other time point. All signs of irritation were fully reversible within 6 days of application. There were no signs of systemic toxicity, or mortality throughout the study.

The key study for eye irritation was conducted according to OECD 405 and in compliance with GLP (Asta-Werke AG, 1987). No apparent effect on the cornea or iris were observed. Conjunctival redness and hyperaemia were observed in all treated animals within 24 hours. However, effects were fully resolved within 48 hours. Slight swelling and discharge were seen in the treated eye of one animal, and swelling with partial eversion of lids was seen in another. These effects were only evident during the first 24 hours following application. There were no overt signs of systemic toxicity or mortality throughout the course of the study.

There is no indication of corrosivity in any of the available studies.

Justification for classification or non-classification

Based on the available information, no classification is required for skin or eye irritation in accordance with Regulation (EC) No. 1272/2008.