[No public or meaningful name is available]

Endpoint summary

Description of key information

Skin irritation/corrosion: OECD 404 (Acute Dermal Irritation)

Rabbit, 4h semiocclusive treatment of clipped intact skin with 0,5 g NA-70 moistened with 0.5 ml water: no effects observed.

 

Eye irritation: OECD 405 (Acute Eye Irritation)

0.027 g NA-70 instilled in rabbit eyes (3 animals), eyes kept unwashed. Observation time points: 1, 24, 48, 72 h after instillation. Slight irritation after application disappeared within 72 hours.

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

24. April 2002

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Albino New Zealand White rabbits
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Weight at study initiation: 2.0 - 3.5 kg
- Age at study initiation: 12 - 20 weeeks
- Housing: individually in suspended metal cages, with environmental enrichment items
- Diet (e.g. ad libitum): Certified Rabbit Diet (Code 5322), BCM IPS Limited, London, UK
- Water (e.g. ad libitum): mains drinking water ad libitum
- Acclimation period: 5 days
- Temperature (°C): 17 - 23
- Humidity (%): 30 to 70

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0,5 g test material

VEHICLE
- Amount applied: 0,5 ml distilled water

- Purity:

NEGATIVE CONTROL
- Amount(s) applied (volume or weight):
- Concentration (if solution):

POSITIVE CONTROL
- Amount(s) applied (volume or weight):
- Concentration (if solution):

Duration of treatment / exposure:

4 hours

Observation period:

1 hours - 4 hours; 24, 48 and 72 hours

Number of animals:

3 (2 male, 1 female)

Details on study design:

TEST SITE
- Area of exposure: 2,5 cm x 2,5 cm
- Type of wrap if used: cotton gauze patch secured with surgical adhesive tape on the skin. To prevent animal interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4 h

SCORING SYSTEM: according to the Draize scheme (Draize, J.H. 1959)

Irritation parameter:

erythema score

Basis:

animal: 99

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

animal: 100

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

animal: 101

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal: 99

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal: 100

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal: 101

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

no erythema, no edema observed

Interpretation of results:

other: not irritant

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

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:

24. April 2002

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Albino New Zealand White rabbits
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Weight at study initiation: 2.0 - 3.5 kg
- Age at study initiation: 12 - 20 weeeks
- Housing: individually in suspended metal cages, with environmental enrichment items
- Diet (e.g. ad libitum): Certified Rabbit Diet (Code 5322), BCM IPS Limited, London, UK
- Water (e.g. ad libitum): mains drinking water ad libitum
- Acclimation period: 5 days
- Temperature (°C): 17 - 23
- Humidity (%): 30 to 70

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1-ml of the test material (0.027 g) was administered into the conjunctival sac of one eye per rabbit. The other eye remained untreated to serve as a control.

Duration of treatment / exposure:

Eyes kept unwashed.

Number of animals or in vitro replicates:

3 male rabbits

Details on study design:

SCORING SYSTEM: Irritation was graded and scored according to the Draize technique (Draize, J. H. 1977). Classification of the ocular irritancy potential was done according to a modified system (Kay, J. H. and Calandra, J. C., 1962).

TOOL USED TO ASSESS SCORE: The light source of a standard ophtalmoscope facilitated eye examination.

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 h

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Corneal irritation or opacity was not evident during the study

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Corneal irritation or opacity was not evident during the study

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Corneal irritation or opacity was not evident during the study

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: iridal changes were not evident during the study

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible within: 24 h

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: iridal changes were not evident during the study

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Irritant / corrosive response data:

The test material produced iridal inflammation and moderate conjunctival irritation when instilled into the eyes of three rabbits.
Two treated eyes appeared normal at the 48-hour observation and the remaining eye appeared normal at the 72-hour observation.

Interpretation of results:

other: not irritating according to European Regulation (EC) 1272/2008.

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

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the data, classification concerning skin irritation/corrosion and eye irritation is not warranted.