2,4-Hexadienoic acid, 3-(trimethoxysilyl)propyl ester, (2E,4E)-

Endpoint summary

Description of key information

The key study for skin irritation for 3-(trimethoxysilyl)propyl-(2E,4E)-hexa-2,4-dienoate concluded that the substance is not irritating to skin. The study was conducted according to OECD TG 404 and in compliance with GLP (BSL Bioservice 2012b).

The key study for eye irritation, conducted according to OECD TG 405 and in compliance with GLP, concluded that the substance is not irritating to eyes (BSL Bioservice 2012c).

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

An in vivo study was conducted because at the time the study was commissioned the available OECD test guidelines for in vitro skin irritation were not validated for silicon-containing substances.

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: Charles River, Germany
- Age at study initiation: 10-11 weeks
- Weight at study initiation: > 2 kg
- Housing: ABS plastic rabbit cages.
- Diet: autoclaved hay and Altromin 2123 maintenance rabbit diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: no data

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

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Remarks:

A dose of 0.5 mL of the test item was applied to each test site.

Controls:

no

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

4 hours

Observation period:

All animals were observed for 72 hours after patch removal.

Number of animals:

3 (male)

Details on study design:

TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: no data
- Type of wrap if used: non-irritating tape, semi-occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: Score 0 in all animals.

Irritation parameter:

erythema score

Basis:

mean

Time point:

48 h

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: Score 0 in all animals

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: Score 0 in all animals

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: Score 0 in all animals.

Irritation parameter:

edema score

Basis:

mean

Time point:

48 h

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: Score 0 in all animals

Irritation parameter:

edema score

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: Score 0 in all animals

Irritant / corrosive response data:

No irritation/ corrosion was observed during the study period.

Other effects:

No changes were observed during the study period.

Interpretation of results:

GHS criteria not met

Conclusions:

The skin irritation/ corrosion toxicity study for 2,4-hexadienoic acid, 3-(trimethoxysilyl)propyl ester concludes that the test material is not irritating or corrosive to the skin.

Executive summary:

The study was performed in order to assess the potential of the test item to induce acute dermal irritation/corrosion when applied directly to the skin of rabbits. Animals were exposed to 0.5 mL of the test item by application onto clipped skin for four hours using a semi-occlusive dressing. The test sites were assessed one, 24, 48, and 72 hours following patch removal. Three male New Zealand White rabbits (Crl: KBL (NZW)) were selected for testing. An initial test was conducted with one of the animals to determine if the test item produced significant irritation. The test item was applied to the two remaining animals selected for testing when the initial test showed that the test item was neither corrosive nor a severe irritant. During the initial test, no irritant or corrosive effects were observed on the intact skin of animal no. 1 immediately after the patch removal. However, very slight erythema was observed 24 and 48 hours after patch removal for this animal. No irritation was observed at any of the scoring intervals for the remaining two animals selected for testing following patch removal. The irritant effects observed were resolved at the end of the 72 hour observation period. No mortalities, significant body weight changes or significant clinical signs of toxicity were observed during the 72 hour observation period. The study was terminated at the end of the 72 hour observation period. As the Total Mean Value for erythema was 0.22 (Maximum Value = 4) and 0.0 for oedema (Maximum Value = 4), under the conditions of this study, the single dermal application of the test item is not expected to produce significant dermal irritation or corrosion.

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:

23 January - 05 July, 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

An in vivo study was conducted because at the time the study was commissioned the available OECD test guidelines for in vitro eye irritation were not validated for silicon-containing substances.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Vehicle:

unchanged (no vehicle)

Controls:

not required

Duration of treatment / exposure:

The test item was applied at a single dose (0.1 mL) in the conjunctival sac of one eye of each test animal after pulling the lower lid away from the eyeball. The lids were then gently held together for about 1 second in order to prevent loss of the material. The untreated contralateral eye served as control.
The treated eye was not rinsed 24 hours after the application.

Observation period (in vivo):

The animals were observed for 72 hours after dosing.

Number of animals or in vitro replicates:

3 (male)

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1 hour

Score:

0

Reversibility:

not specified

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24 h

Score:

0

Reversibility:

not specified

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

48 h

Score:

0

Reversibility:

not specified

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

72 h

Score:

0

Reversibility:

not specified

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 1 hour

Score:

0

Reversibility:

not specified

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24 h

Score:

0

Reversibility:

not specified

Irritation parameter:

chemosis score

Basis:

mean

Time point:

48 h

Score:

0

Reversibility:

not specified

Irritation parameter:

chemosis score

Basis:

mean

Time point:

72 h

Score:

0

Reversibility:

not specified

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 1 hour

Score:

0

Reversibility:

not specified

Irritation parameter:

iris score

Basis:

mean

Time point:

24 h

Score:

0

Reversibility:

not specified

Irritation parameter:

iris score

Basis:

mean

Time point:

48 h

Score:

0

Reversibility:

not specified

Irritation parameter:

iris score

Basis:

mean

Time point:

72 h

Score:

0

Reversibility:

not specified

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1 hour

Score:

0

Reversibility:

not specified

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24 h

Score:

0

Reversibility:

not specified

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

48 h

Score:

0

Reversibility:

not specified

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

72 h

Score:

0

Reversibility:

not specified

Other effects:

none observed.

There were no significant body weight changes during the observation period.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the present study, a single ocular application of the test item2,4-hexadienoic acid, 3-(trimethoxysilyl) propyl ester to rabbits at a dose of 0.1 mL produced no irritant effects.

Executive summary:

The study was performed in order to assess the potential of the test item to induce the irritant and/or corrosive effects on eyes when applied to rabbits. Animals were exposed to 0.1 mL of the test item administered as a single dose in the conjunctival sac of one eye. The lids were gently held together for about 1 second in order to prevent loss of the test item. The eyes were examined 1 hour and then 24, 48, and 72 hours after the application of the test item. Three male New Zealand White rabbits (Crl: KBL (NZW)) were selected for testing. An initial test was conducted with one of the animals to determine if the test item produced significant irritation. The test item was applied to the two remaining animals selected for testing when the initial test showed that the test item was neither corrosive nor a severe irritant. During the initial test, no irritant or corrosive effects were observed for animal no. 1 following the administration of the test item. In addition, no irritation was observed at any of the scoring intervals for the remaining two animals selected for testing. The study was terminated at the end of the 72 hour observation period. Under the conditions of the present study, a single ocular application of the test item 2,4 -hexadienoic acid, 3-(trimethoxysilyl) propyl ester to rabbits at a dose of 0.1 mL produced no irritant effects.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The key study for skin irritation for 3-(trimethoxysilyl)propyl-(2E,4E)-hexa-2,4-dienoate, concluded that the substance is not irritating to skin. The study was conducted according to OECD TG 404 and in compliance with GLP (BSL Bioservice 2012b). Following a 4 -hour application of the test material onto the skin of three rabbits, mild erythema was observed in one animal at 24 hours and 48 hours post treatment. No erythema or oedema was noted in any of the other animals during the 72 hour study period. The mean erythema score was 0.22 out of the maximum 4, and the oedema score was 0 out of the maximum 4.

The key study for eye irritation, conducted according to OECD TG 405 and in compliance with GLP, concluded that the substance is not irritating to eyes (BSL Bioservice 2012c). Under the conditions of the study, a single ocular application of the test item 3-(trimethoxysilyl)propyl-(2E,4E)-hexa-2,4-dienoate to rabbits at a dose of 0.1 mL produced no irritant effects.

Justification for classification or non-classification

Based on the available data for 3-(trimethoxysilyl)propyl-(2E,4E)-hexa-2,4-dienoate, no classification for skin or eye irritation is required according to Regulation (EC) No. 1272/2008.