Registration Dossier

Diss Factsheets

Administrative data

Description of key information

No in vitro or in vivo skin or eye irritation data are available for 3-(triethoxysilyl)propiononitrile, therefore the available data for the related substance 3-(trimethoxysilyl)propriononitrile have been read across.

In a non-GLP skin irritation study that was similar to OECD Test Guideline 404, the test material was slightly irritating (minor erythema in 6/6 animals and slight oedema in 1/6 animals) to the skin of rabbit (Bushy Run Research Center, 1982).

In a non-GLP eye irritation study that was similar to OECD Test Guideline 405, the test material was slightly irritating (minor corneal injury, iritis, and conjunctival redness and chemosis) to the eyes of rabbits (Bushy Run Research Center, 1982).  

In both cases the irritation was minor and therefore not sufficient to trigger classification. There are no data for respiratory tract irritation; however, based on the skin and eye irritation data, respiratory tract irritation is not expected.


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:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Reversibility was not determined as observations were only made for 7 days, limited information on test material, size of exposure area not specified, sex of animals not given, lack of details on environmental conditions.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: 200-300 g
- Fasting period before study: No
- Housing: No data
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: No data
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
not specified
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
Four hours.
Observation period:
Seven days.
Number of animals:
Six.
Details on study design:
TEST SITE
- Area of exposure: No data
- % coverage: No data
- Type of wrap if used: Impervious sheeting

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: four hours

SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 2 days
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 2 days
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 5 hours
Score:
0
Max. score:
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
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
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
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
This primary skin irritation study resulted in slight erythema all six rabbits (grade 1 in five, grade 2 in one animal) persisting to seven days in one animal only (grade 1), oedema in one animal on days 2 -7 (grade 1), and desquamation in three rabbits after one day, which persisted to day 7.
Other effects:
No other effects reported in the summary report.
Interpretation of results:
GHS criteria not met
Conclusions:
In a primary skin irritation study, not conducted to GLP (reliability score 2), 3-(trimethoxysilyl)propionitrile was slightly irritating (minor erythema in 6/6 animals and slight oedema in 1/6 animals) to the skin of rabbits.
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:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Limited details on TS and environmental conditions.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: 200-300 g
- Fasting period before study: No
- Housing: No data
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: No data
Vehicle:
not specified
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
Eyes not washed.
Observation period (in vivo):
Up to 14 days as necessary.
Number of animals or in vitro replicates:
Six
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: No

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein
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:
0.2
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:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #4
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 #5
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 #6
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:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #6
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
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Corneal injury (grade 1) was observed in one rabbit at six hours, persisting through to 24 hours. Iritis (grade 1) was present at one hour in three of six animals. Conjunctival injury (redness and chemosis: grades 1 and 2) was observed in all six animals and persisted to 24 hours in one animal. There were no signs of irritation by 48 hours.
Other effects:
No other effects included in the study summary.
Interpretation of results:
GHS criteria not met
Conclusions:
In an eye irritation study, not conducted to GLP (reliability score 2), 3-(trimethoxysilyl)propiononitrile was slightly irritating (minor corneal injury, iritis, and conjunctival redness and chemosis) to the eyes of rabbits.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

No in vitro or in vivo skin or eye irritation data are available for 3-(triethoxysilyl)propiononitrile, therefore the available data for the related substance 3-(trimethoxysilyl)propiononitrile have been read across.

In a non-GLP skin irritation study that was similar to OECD Test Guideline 404, minor skin reactions were observed that were not fully reversed in one animal (out of six) at the end of the 7-day observation period. However, it is likely that this would have been reversed if the study had been extended to the standard 14-days specified in current guidelines.

In a non-GLP eye irritation study that was similar to OECD Test Guideline 405, application of 0.1 mL of undiluted 3-(trimethoxysilyl)propiononitrile to the eyes of six New Zealand white rabbits resulted in conjunctival scores (mean of 24, 48 and 72 hours) of between 0 (five animals) and 0.33 (one animal), chemosis scores (mean of 24, 48, 72 hours) between 0 (five animals) and 0.33 (one animal), cornea scores (mean of 24, 48, 72 hours) between 0 (five animals) and 0.33 (one animal). Minor corneal injury, trace iritis, conjunctival redness and chemosis were observed shortly after instillation of the test material but quickly disappeared. It is concluded that the test substance is not irritating to the eye.

Please refer to the RAAF read-across justification document attached to Section 13 for more details.

Justification for classification or non-classification

On the basis of the available in vivo data for the related substance 3-(trimethoxysilyl)propiononitrile, the registered substance

3-(triethoxysilyl)propiononitrile is not classified as a skin or eye irritant according to the criteria of Regulation (EC) No 1272/2008.