Silicon boride oxide

Endpoint summary

Description of key information

Skin irritation: erythema score 0, edema score 0
Eye irritation: cornea score 0, iris score 0, conjunctiva score 0.6, chemosis score 0.1

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:

March - April 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline- and GLP study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Qualifier:

according to guideline

Guideline:

other: Japan MAFF 8147

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
- Age at study initiation: approx. 5 months
- Sex: Females
- Weight at study initiation: 3.38 - 3.80 kg
- Housing: Single
- Diet (e.g. ad libitum): STANRAB (P) SQC; SDS Special Diets Services, 67122 Altrip, Germany (ad libitum)
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 5 days before application

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 30 – 70%
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Remarks:

The solid test item was minimally moistened with a suitable amount of highly deionized water to guarantee skin contact immediately before test-item application.

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

4 hours

Number of animals:

3

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24h

Score:

0

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 48h

Score:

0

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72h

Score:

0

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24h

Score:

0

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 48h

Score:

0

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 72h

Score:

0

Interpretation of results:

not irritating

Remarks:

Migrated information

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:

March - April 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study according to OECD testing guideline and under GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Qualifier:

according to guideline

Guideline:

other: Japan MAFF 8147

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River
- Age at study initiation: Approx. 3 months
- Sex: Females
- Weight at study initiation: 2.45 kg – 3.01 kg
- Housing: Single
- Diet (e.g. ad libitum): STANRAB (P) SQC; SDS Special Diets Services, 67122 Altrip, Germany (ad libitum)
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: at least 5 days before application

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 30 – 70%
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL bulk volume (about 16 mg of the comminuted test item)

Duration of treatment / exposure:

24 hours

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): About 24 hours after application of the test item the treated eye of the animal(s) was rinsed with 3 to 6 mL of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe.

SCORING SYSTEM: The evaluation of eye irritation was performed according to the quoted guidelines. In addition to specific observations recommended by the regulatory authorities, evaluations were made of discharge from the eye and the area of cornea affected by the lesions.

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24h

Score:

0

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 48h

Score:

0

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 72h

Score:

0

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24h

Score:

0

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 48h

Score:

0

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 72h

Score:

0

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24h

Score:

0.3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 48h

Score:

0.7

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 72h

Score:

0.7

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24h

Score:

0.3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 48h

Score:

0

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 72h

Score:

0

Irritant / corrosive response data:

Slight conjunctival redness (grade 1) was noted in all animals from 1 hour up to 24 or 48 hours after application, respectively.
Slight conjunctival chemosis (grade 1) was noted in two out of three animals 1 hour after application and in the third animal 24 hours after application.
Slight discharge (grade) was noted in two out of three animals 1 hour after application.
Additional findings like injected scleral vessels in a circumscribed area were noted in one animal from hour 1 until hour 48 after application. Test item residues were observed in two out of three animals 1 hour after application only.
The ocular reactions were reversible in all animals within 72 hours after application at the latest.

Interpretation of results:

not irritating

Remarks:

Migrated information

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin irritation/corrosion:

An in vitro skin corrosion test showed no corrosive effect for silicon boride oxide (tissue viability 95% after 3min, 125% after 1h). Irritating effects of the substance were tested in a skin irritation test according to OECD TG 404. No effects were observed.

Eye irriation/corrosion:

Corrosive properties of the test substance were assessed in a HET-CAM assay; the test substance did not produce changes indicative for serious eye damage. The potential for eye irritation was tested in an eye irritation test in vivo according to OECD TG 405. Slight reddening of the conjunctiva as well as minimal chemosis was observed; all effects were reversible within 72h.

Justification for selection of skin irritation / corrosion endpoint:
Guideline and GLP study

Justification for selection of eye irritation endpoint:
Guideline and GLP study

Justification for classification or non-classification

Based on the data available, silicon boride oxide does not fulfill the criteria for classification layed out in EC 1272/2008 (CLP). Therefore, non-classification is warranted.