Diethoxy(methyl)silane

Endpoint summary

Description of key information

Skin (OECD 404): not irritating 
Eye (OECD 405): 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:

11 Feb - 16 Feb 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(2002)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Version / remarks:

(1998)

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:

Bayrisches Landesamt für Arbeitsschutz, Arbeitsmedizin und Sicherheitstechnik

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Weight at study initiation: 3800 - 4500 g
- Housing: Animals were caged in plastic rabbit cages (4200 cm² floor)
- Diet: Altromin 2123 maintenance diet for rabbits, ad libitum
- Water: (tap/filtered) water, ad libitum
- Acclimation period: adequate period

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)

Controls:

other: untreated sites of the same animal served as control

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

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

Number of animals:

3 females

Details on study design:

TEST SITE
- Area of exposure: 6 cm² on one site of the dorsal area
- Type of wrap if used: The treated skin was covered with a gauze patch, which was held in place with non-irritating tape. The patch was fixed with a semi-occlusive dressing.

SCORING SYSTEM: Draize scoring system

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

Based on the results of the study the test item is non-irritant.

Other effects:

There were no remarkable body weight changes during the contact and observation period.

Interpretation of results:

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

Conclusions:

In the reliable skin irritation study performed according to OECD TG 404 and in compliance with GLP, the mean values for erythema and edema in rabbits were 0.0 and 0.0, respectively. Therefore, the test substance does not need to be classified for skin irritation according to Regulation (EC) No 1272/2008.

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:

18 Feb - 23 Feb 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(2002)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

(2002)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Version / remarks:

(1998)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Bayerisches Landesamt fuer Arbeitsschutz, Arbeitsmedizin und Sicherheitstechnik, Munich, Germany

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen
- Weight at study initiation: animal #1: 3.2 kg, #2: 3.3 kg, #3: 3.4 kg
- Housing: in ABS-Plastic rabbit cages, floor 4200 cm²
- Diet: Altromin 2123 maintenance diet for rabbit, rich in crude fibre, totally pathogen free (TPF), ad libitum
- Water: tap water (drinking water, municipal residue control, microbiol. controlled periodically), ad libitum
- Acclimation period: at least 5 days

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

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

72 hours
reading time points: 1, 24, 48 and 72 hours

Number of animals or in vitro replicates:

3 females

Details on study design:

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

over all three animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

iris score

Basis:

mean

Remarks:

over all three animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

over all three animals

Time point:

24/48/72 h

Score:

0.11

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

over all three animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

Animal No. 1 and 3 showed redness grade 1 of the conjunctivae 1 hour post instillation. 24 hours post instillation until the end of the observation period no signs of irritation were recorded.
Animal No. 2 showed redness grade 1 of the conjunctivae 1 hour, as well as 24 hours post instillation. 48 hours, as well as 72 hours post instillation no signs of irritation were recorded.

Other effects:

Throughout the observation period no weight loss was observed for the test animals.

Interpretation of results:

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

Conclusions:

In conclusion, under the conditions chosen for the present study (according to OECD 405 and GLP) the test substance did not show eye irritating potential. Only one animal showed a slight redness of the conjunctivae which was fully reversed after 48 hours. Therefore, the stest substane does not need to be classified for eye irritation.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation/corrosion

Two skin irritation studies with diethoxy(methyl)silane (CAS 2031-62-1) are available.

In the key skin irritation study performed according to OECD TG 404 and in compliance with GLP three female New Zealand White rabbits were exposed to 0.5 mL of the neat test material (CAS 2031-62-1) for 4 hours applied onto the clipped skin via semi-occlusive dressing (BSL, 2007). Skin reactions were evaluated 1, 24, 48 and 72 hours post-application. Neither erythema nor edema formation were observed during the study period. There were no remarkable body weight changes during the contact and observation period.

In a supporting skin irritation study performed according to OECD TG 404 and in compliance with GLP three New Zealand White rabbits of each sex were exposed to 0.5 mL of the neat test material for 4 hours applied onto the clipped skin via semi-occlusive dressing (WIL, 1996). Skin reactions were evaluated 1, 24, 48 and 72 hours as well as 4, 5, 6 and 7 days post-application. No mortalities occurred during the study period. Five rabbits showed very slight to slight erythema formation (grade 2) one hour and 24 to 72 hours (grade 1 and 2) post-application. The mean score for erythema was 0.83. Only very slight edema formation was noted in one male animal one hour post application (grade 1), which was fully reversible within 24 hours post-application. No remarkable body weight changes were noted during the study period. Based on the above study results and according to EU classification criteria, the test substance is considered to be not-irritating.

Eye irritation

Two eye irritation studies with diethoxy(methyl)silane (CAS 2031-62-1) are available.

In the key eye irritation study performed according to OECD TG 405 and in compliance with GLP 0.1 mL of diethoxy(methyl)silane (CAS 2031-62-1) was instilled in the eye of three female New Zealand White rabbits (BSL, 2007). The eyes were examined and the changes were graded according to the Draize scoring system 1, 24, 48 and 72 hours post-application. All animals showed redness (grade 1) of the conjunctivae 1 hour post-application which was fully reversible within 48 hours post-application. No further signs of irritation and mo remarkable body weight changes were noted during the study period.

In a supporting eye irritation study performed according to OECD TG 405 and in compliance with GLP 0.1 mL of the test substance was instilled in the eye of six male New Zealand White rabbits (WIL, 1996). The eyes were examined and the changes were graded according to the Draize scoring system 1, 24, 48 and 72 hours as well as 4 and 7 days post-application. There were no corneal or iridal findings during the study period. All animals showed redness (grade 1 or 2) of the conjunctivae 1 hour post-application which was fully reversible within 4 days or earlier. Chemosis (grade 1) was noted in all animals 1 hour post-application, but was fully reversible within 24 hours post-application. The calculated mean value for conjunctiva was 0.56. No mortalities occurred and no remarkable changes or differences in body weights were observed during the study period. Based on the above study results and according to EU classification criteria, the test substance is considered to be not-irritating.

Justification for classification or non-classification

The available data on skin and eye irritation of Diethoxy(methyl)silane (CAS 2031-62-1) do not meet the criteria for classification according to Regulation (EC) No 1272/2008 and are therefore conclusive but not sufficient for classification.