Trimethoxy(2,4,4-trimethylpentyl)silane

Endpoint summary

Description of key information

Skin irritation/corrosion (OECD 404, GLP, RL1), rabbit: not irritating
Eye irritation (OECD 405, GLP, RL1), rabbit: not irritating

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:

04 March - 29 April 2002

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

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

FREIE UND HANSESTADT HAMBURG; BEHÖRDE FÜR ARBEIT, GESUNDHEIT UND SOZIALES, Germany

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: LPT Laboratory of Pharmacology and Toxicology KG
- Age at study initiation: 3.5-4 months
- Weight at study initiation: 1.9-2.0 kg
- Housing: Individually in cages measuring 425x600x380 mm
- Diet: ssniff K-H (ssniff Spezialdiäten GmbH, Soest, Germany; analysed for contaminants at least twice a year), ad libitum
- Water: tap water (analysed for contaminants at least twice a year), ad libitum
- Acclimation period: At least 20 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 55±15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From 09 April 2002 to 29 April 2002

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 ml

Duration of treatment / exposure:

4 h

Observation period:

96 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: Semi-occlusive

REMOVAL OF TEST SUBSTANCE
- Washing: No

SCORING SYSTEM: Draize scoring system

Irritation parameter:

erythema score

Basis:

animal: #1 and #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 96 h

Irritation parameter:

edema score

Basis:

mean

Remarks:

over all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

Animals 1 and 2 showed no signs of irritation at any time point. Animal 3 had an erythema (grade 1) from 60 minutes up to 72 hours after patch removal.

Other effects:

There were no other effects reported.

Interpretation of results:

other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No. 1272/2008

Conclusions:

The test item was tested for skin irritation/corrosion according to the OECD TG 404 and in complinance with GLP. Minor erythema (score 1) was observed in one out of three animals, which was reversible within 96 hours. Hence, the test item was found to be not irritating and classification according to Regulation (EC) No. 1272/2008 is not warranted.

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:

22 October - 01 November 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventionell bred
- Age at study initiation: 3-5 months
- Weight at study initiation: 3.1-3.3 kg
- Housing: in individual cages (battery housing)
- Diet: Altromin 2123 Haltungsdiät - Kaninchen (Altromin GmbH, Lage/Lippe, Germany), ad libitum; and 15 g hay daily
- Water: deionised and chlorised water, ad libitum, provided in automated drinking troughs

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±3
- Humidity (%): 55±20
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 22 October 1991 to: 01 November 1991

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 ml

Duration of treatment / exposure:

24 h

Observation period (in vivo):

Reading time points: 1, 24, 48, and 72 h

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: with physiol. NaCl solution at 37 °C
- Time after start of exposure: after 24 h and at every reading time point, when dicharge was observed or the eyes were determined for corneal damage using fluorescein

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

over all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritation parameter:

iris score

Basis:

mean

Remarks:

over all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

over all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

One hour after exposure the conjunctivae had diffuse redness and partial eversion of the eyelids. After 24 hours two animals had marked hyperaemia. After 48 hours the irritation had reversed.

Other effects:

None reported.

Interpretation of results:

other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No. 1272/2008

Conclusions:

The test item was tested for eye irritation according to OECD TG 405 and in compliance with GLP. One hour after exposure the conjunctivae had diffuse redness and partial eversion of the eyelids. After 24 hours two animals had marked hyperaemia (grade 1). One animal fully recovered within 24 h, the other two animals fully recovered within 48 h. Based on these findings classification according to Regulation (EC) No. 1272/2008 is not warranted.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation/corrosion:

In the available key study the test item (91.5% pure) was tested for eye irritation according to the OECD TG 404 and in compliance with GLP (LPT, 2002). 0.5 ml of the test material was applied to the shaved, intact skin of three Himalayan rabbits and was covered using a semi-occlusive dressing for four hours. After four hours the dressing was removed and no washing was required. An erythema (grade 1) was observed in one animal from 60 minutes up to 72 hours after the patch removal. There were no substance-related changes at the examination time points of 1, 24, 48 and 72 hours for the other two animals. There were no signs of systemic toxicity. Hence, the test item was considered non-irritating to the skin.

Eye irritation:

In the available key study the test item was tested for eye irritation according to the OECD TG 405 and in compliance with GLP (Hoechst, 1991). Three New Zealand White rabbits received the unchanged test material, which was rinsed off the eyes 24 hours after instillation. One hour after exposure the conjunctiva had diffuse redness and partial eversion of the eyelids (conjunctival score = 2) in all animals. After 24 hours two animals still had marked hyperaemia (conjunctival score = 1) that were fully reversible within 48 h. Thus, the mean score over 24, 48 and 72 h out of all 3 animals for conjunctival redness is 0.2. Scores for cornea, iris, and chemosis were 0 at any reading time points in all animals. Based on these findings classification for eye irritation is not warranted.

Justification for classification or non-classification

The available data on skin irritation/corrosion and eye irritation of the test substance do not meet the criteria for classification according to Regulation (EC) No. 1272/2008, and are therefore conclusive but not sufficient for classification.