Registration Dossier

Administrative data

Description of key information

In the key in vivo skin irritation study, conducted according to OECD Test Guideline 404 and in compliance with GLP, triethoxy(2,4,4-trimethylpentyl)silane was concluded to be not irritating to rabbit skin (BSL Bioservice, 2000a).

In the key in vivo eye irritation study, conducted according to OECD Test Guideline 405 and in compliance with GLP, triethoxy(2,4,4-trimethylpentyl)silane was concluded to be not irritating to the eyes of rabbits (BSL Bioservice, 2001b).

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:
120 hours
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing:ABS - plastic cages, floor 4200 cm2
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Described as 'adequate'.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18± 3
- Humidity (%): 55± 10
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
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:
120 hours
Number of animals:
Three
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- % coverage: Not stated
- Type of wrap if used: gauze patch held in place with non-irritating tape and semi-occlusive dressing.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with water.
- Time after start of exposure: Four hours.


SCORING SYSTEM: As per OECD 404.

Individual reactions of each animal were recorded at each observation time (1, 24, 48, 72, 96 and 120 hours). Nature, severity and duration of all lesions observed were described. Body weight were recorded at the start of the study and 72 hours after patch removal.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 96 hours
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.33
Max. score:
4
Reversibility:
fully reversible within: 120 hours
Remarks on result:
probability of mild irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
probability of weak 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
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
Irritant / corrosive response data:
Very slight to moderate irritant effects (erythema) in all three animals on the intact skin 24 hours after patch removal. Very slight to well-defined skin reactions (erythema) in two animals at 48 and 72 hours. At the 96 hour reading a very slight erythema was still found in one animal. By 120 hours there were no signs of irritation.
Other effects:
There were no significant body weight changes at any point in the study. There were no other signs of toxicity.
Interpretation of results:
GHS criteria not met
Conclusions:
In the in vivo skin irritation study, conducted according to OECD Test Guideline 404 and in compliance with GLP, triethoxy(2,4,4-trimethylpentyl)silane was concluded to be not irritating to rabbit skin.
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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: ABS, plastic cages.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Described as 'adequate'.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±3
- Humidity (%): 55±10
- Air changes (per hr): At least 10
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml


Duration of treatment / exposure:
No washing.
Observation period (in vivo):
72 Hours.
Number of animals or in vitro replicates:
Three
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No washing


SCORING SYSTEM: As per OECD 405.


TOOL USED TO ASSESS SCORE: At the end of the observation period the eyes were examined with the aid of a fluoresceinsolution.

Eyes were examined for signs of irritation at 1, 24, 48 and 72 hours after instillation.
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
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:
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:
One hour after application, redness (grade 1/2) was visible in two animals, and chemosis (grade 1) of the conjunctivae was additionally visible in one animal. No corneal lesions were found upon fluorescein examination at 72 hours. There were no signs of irritation at 24, 48 and 72 hours.
Other effects:
No other clinical signs of toxicity were reported.
Interpretation of results:
GHS criteria not met
Conclusions:
In the in vivo eye irritation study, conducted according to OECD Test Guideline 405 and in compliance with GLP, triethoxy(2,4,4-trimethylpentyl)silane was concluded to be not irritating to the eyes of rabbits.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In the in vivo skin irritation study, conducted according to OECD Test Guideline 404 and in compliance with GLP, triethoxy(2,4,4-trimethylpentyl)silane was applied to one side of the closely clipped backs of three New Zealand white rabbits at a dose of 0.5 ml per application site under a semi-occlusive dressing for 4 hours. The other side of the untreated skin on the backs of the rabbits served as the controls. After the 4-hour application period, the dressing was removed and excess test substance was washed off the skin with water. Observations were recorded and compared to the control sites at 1, 24, 48, 72, 96 and 120 hours after removal of the dressing. Very slight to moderate irritant effects (erythema) were observed in all three animals after 24 hours. Very slight to well-defined skin reactions (erythema) were observed in two animals at 48 and 72 hours. At the 96-hour reading a very slight erythema was still found in one animal. However, by 120 hours there were no signs of irritation. No clinical signs of toxicity were observed. Triethoxy(2,4,4-trimethylpentyl)silane was concluded to be not irritating to rabbit skin (BSL Bioservice, 2000a).

In the key in vivo eye irritation study, conducted according to OECD Test Guideline 405 and in compliance with GLP, triethoxy(2,4,4-trimethylpentyl)silane was applied to the lower conjunctival sac of one eye of three New Zealand white rabbits at a dose of 0.1 ml. The eye was held shut for one second to prevent loss of the test substance. The eyes were not rinsed. The untreated eye of each animal served as a control. At 1, 24, 48 and 72 hours after instillation the eyes were examined for signs of irritation. One hour after application, redness (grade 1/2) was visible in two animals, and chemosis (grade 1) of the conjunctivae was additionally visible in one animal. No corneal lesions were found upon fluorescein examination at 72 hours. There were no signs of irritation at 24, 48 and 72 hours. Triethoxy(2,4,4-trimethylpentyl)silane was concluded to be not irritating to the eyes of rabbits (BSL Bioservice, 2001b).

Justification for classification or non-classification

Based on the available in vivo skin and eye irritation studies, triethoxy(2,4,4 -trimethylpentyl)silane is not classified for skin or eye irritation according to Regulation (EC) No 1272/2008.