Registration Dossier

Administrative data

Description of key information

The substance was not irritating to both skin and eyes when tested with rabbits.

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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
occlusive conditions
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GMBH, Biberach/Riss
- Age at study initiation: approx. 12-14 weeks old
- Weight at study initiation: 2350 - 2580 g
- Housing: individually
- Diet (e.g. ad libitum): ad libitum standard rabbit pellet - Nafag, No. 814, Gossau, Switzerland
- Water (e.g. ad libitum): fresh water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 hours/12 hours
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: A control gauze patch moistened with distilled water was applied to the contralateral flank.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
4 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 12-16 cm2
- Type of wrap if used: The patches were loosely covered with an aluminum foil (approx. 36 cm2 ) and held by an adhesive tape (Isoplast).

SCORING SYSTEM: OECD scoring system
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: Very slight erythema was observed one hour after exposure
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: Very slight erythema was observed one hour after exposure
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant, no findings
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 7 days
Interpretation of results:
GHS criteria not met
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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GMBH, Biberach/Riss
- Age at study initiation: approx. 12-14 weeks old
- Weight at study initiation: 2500 to 2770 g
- Housing: individually
- Diet (e.g. ad libitum): standard rabbit pellet (Nafag, No. 814, Gossau, Switzerland), ad libitum
- Water (e.g. ad libitum): fresh water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 hours/12 hours
Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye remained untreated and served as a control.
Amount / concentration applied:
0.1 ml
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: OECD scoring system
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not relevant
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: Slight redness after one hour.
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: Slight chemosis after one hour.
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: Slight chemosis after one hour.
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

A GLP conform in vivo study was performed to assess the acute dermal irritation or corrosion potential of the test substance in White New Zealand rabbits according to the OECD guideline 404 (1989). An amount of 0.5 ml of the test substance was once topical applied for 4 hours to the intact skin of three rabbits, using a patch of 12-16 cm2, covered with occlusive dressing. The average score (24 to 72 hours) for irritation effects was calculated to be 0.3 for erythema and 0 for edema. Signs of skin irritation were reversible within 7 days after removal of the patches. Considering the described skin reactions, the test substance does not show a skin irritation potential under the test conditions chosen.

 

Eye irritation

To assess the acute eye irritation potential of the test substance in vivo a GLP conform eye irritation test in White New Zealand rabbits was performed according to the method described in OECD guideline 405 (1989). An amount of 0.1 ml of the test substance was single ocular applied to three rabbits. The average score (24 to 72 hours) for irritation was calculated to be 0.0 for corneal opacity and iris, 0.67 for conjunctivae redness and 0.22 for chemosis. The findings were reversible in all animals within 14 days after application, thus the study was terminated. Symptoms observed and described in the respective observation table in detail together with the average score for irritation do not indicate an irritant property of the test substance to the eye.

Respiratory irritation

no data

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. The substance is not considered to be classified for irritation under Regulation (EC) No 1272/2008.