SDBR

Endpoint summary

Description of key information

Based on the results of reliable in vivo tests it is concluded that SDBR is not irritant (or corrosive) to the skin and eye.

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:

April 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Specific details on test material used for the study:

Stability: stable
Solubility: toluene, methylene chloride
Storage Conditions: Room temperature

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Eastern Rabbit Breeding Laboratory, Taunton, MA, USA
- Age at study initiation: 10-12 weeks
- Weight at study initiation: 2-3 kg
- Housing: individual housing using suspended stainless steel cages. Hardwood chips were used as bedding material
- Diet: controlled diet of a commercial rabbit ration (Agway Prolab, Waverly, NY)
- Water: municipal tap water, ad libitum
There were no known contaminants present in the feed, bedding or water expected to interfere with the test results.
- Acclimation period: minimum of 3 days

ENVIRONMENTAL CONDITIONS (SET CONDITIONS)
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Air changes (per hr): minimum 10-13
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 08 April To: 11 April 1994

Type of coverage:

occlusive

Preparation of test site:

clipped

Remarks:

The skin site was not abraded, either deliberately, or accidentally during clipping of the fur.

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

4 h

Observation period:

Animals were observed for signs of erythema and edema at 30-60 minutes, and then at 24, 48 and 72 hours after the 4 hour exposure period. observations were scored according to the "Draize scale for Scoring Skin Reactions".

Number of animals:

3 males and 3 females

Details on study design:

The test substance was applied under gauze patches measuring 1 square inch. The patches were applied to an intact skin site on each animal. The test substance was kept in contact with the skin for 4 hours by wrapping with an impervious, non-irritating bandage, Vetrap (3M, St. Paul, MN).
At the end of the exposure period, the wrapping was removed and the skin wiped to remove any residual test substance.
Clinical observations were conducted daily, for all clinical signs.

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No signs of erythema or edema were noted in any of the test or control sites during the observation period.

Other effects:

There was no evidence of pain and suffering during the observation period. No overt signs of toxicity were evident during the course of the study. All animals survived the test and exhibited a gain in body weight during the observation period

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of a reliable in vivo test it is concluded that SDBR is not irritant (or corrosive) to the 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

Study period:

08 April - 11 April 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other: TSCA, 40 CFR, part 798, subpart E guideline section 798.000 (1989)

GLP compliance:

yes

Specific details on test material used for the study:

Stability: stable
Solubility: toluene, methylene chloride
Insoluble: water
Storage conditions: Room temperature

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Eastern Rabbit Breeding Laboratory, Taunton, MA, USA
- Age at study initiation: 10-12 weeks
- Weight at study initiation: 2-3 kg
- Housing: Individually housed in suspended stainless steel cages with hardwood chips as bedding material
- Diet: commercial rabbit ration (Agway Prolab, Waverly, NY), ad libitum
- Water: municipal tap water, ad libitum
- Acclimation period: minimum of 3 days

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

IN-LIFE DATES: From: 08 April To: 11 April 1994

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

100 mg; The test substance was grounded to a fine powder. The weight of 0.1 mL volume of the powder was greater than 100 mg.

Duration of treatment / exposure:

Single instillation

Observation period (in vivo):

Eyes were examined at 1, 24, 48, and 72 hours after treatment using the Draize scale. Fluorescein staining was used during each examination, excluding the 1 hour exam. Reading of reactions was facilitated by the use of a hand held slit-lamp.

Number of animals or in vitro replicates:

3 males and 3 females

Details on study design:

Both eyes of each rabbit were examined for macroscopic findings with a fluorescein dye procedure before the experimental start.

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #3

Time point:

24 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

cornea opacity score

Basis:

animal: 1, 2, 3, 4, 5 and 6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal: 1, 2, 3, 4, 5 and 6

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal: 1, 2, 4, 5 and 6

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal: 1, 2, 3, 4, 5 and 6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No positive signs of irritation were noted in the treated or control eyes at any of the observation points. No fluorescein staining was observed in the treated or control eyes at any observation point. No fluorescein staining was performed at the 1 hr observation point.

Other effects:

All animals exhibited an increase in body weight during the course of the study.
No overt signs of toxicity were evident during the course of the study, in any of the animals.

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of an in vivo eye irritation study with 6 rabbits it is concluded that SDBR has no adverse effects on the eye.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the available data, the test substance is not classified for irritant or corrosive properties to the skin and eye according to Regulation (EC) No 1272/2008.