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Administrative data

Description of key information

In the key skin irritation study, conducted according to appropriate OECD test guidelines and in compliance with GLP, the test material was reported to be not irritating to skin (RCC, 2004).

In the key eye irritation study, conducted according to appropriate OECD test guideline and in compliance with GLP, the test material was reported to be not irritating to eyes (RCC, 2004).

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:
29 June 2004 to 08 July 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
2002
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature, protected from light
- Stability under test conditions: stable under test conditions
- Solubility and stability of the test substance in the solvent/vehicle: not applicable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test material was applied undiluted.
- Preliminary purification step (if any): none
- Final dilution of a dissolved solid, stock liquid or gel: not applicable
- Final preparation of a solid: not applicable
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage Scientifique des Dombes, France
- Age at study initiation: 10 weeks
- Weight at study initiation: not specified
- Housing: individually in stainless steel cages
- Diet: pelleted standard rabbit maintenance diet, ad libitum
- Water: community tap water, ad libitum
- Acclimation period: Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70%
- Air changes (per hour): 10-15
- Photoperiod (hours dark / hours light): 12/12
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): not applicable

VEHICLE
The test material was applied undiluted.

NEGATIVE CONTROL
Not used.

POSITIVE CONTROL
Not used.
Duration of treatment / exposure:
4 hours
Observation period:
at 24, 48 and 72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: left flank
- % coverage: 10 % (10cm x 10cm)
- Type of wrap if used: The patch was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes. The skin was flushed with lukewarm water.
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
The animals were observed daily from acclimatisation period till study termination for mortality, viability and clinical signs of toxicity. Body weights were recorded at start of acclimatisation, on the day of application and at termination of observation.

SCORING SYSTEM:
- Method of calculation: Draize
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No clinical signs of systemic toxicity were observed in any of the test animals during the study and no mortality occurred. Neither alterations of the treated skin were observed nor were corrosive effects evident on the skin. Body weight of all rabbits were considered to be within the normal range of variability.
Other effects:
None
Interpretation of results:
GHS criteria not met
Conclusions:
In the skin irritation study, conducted according to appropriate OECD test guidelines and in compliance with GLP, the test material was reported to be not irritating to 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:
20 July 2004 to 30 July 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2002
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
2002
Deviations:
no
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature, protected from light
- Stability under test conditions: stable under test conditions
- Solubility and stability of the test substance in the solvent/vehicle: not applicable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test material was applied undiluted.
- Preliminary purification step (if any): none
- Final dilution of a dissolved solid, stock liquid or gel: not applicable
- Final preparation of a solid: not applicable
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage Scientifique des Dombes, France
- Age at study initiation: 12 weeks males and 11-12 weeks females
- Weight at study initiation: not specified
- Housing: Individually in stainless steel cages.
- Diet: pelleted standard rabbit maintenance diet, ad libitum
- Water: community tap water, ad libitum
- Acclimation period: Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23°C
- Humidity (%): 30-70%
- Air changes (per hour): 10-15
- Photoperiod (hours dark / hours light): 12/12

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): not applicable

VEHICLE
The test material was applied undiluted.
Duration of treatment / exposure:
Single instillation
Observation period (in vivo):
at 1 and 24 hours
Duration of post- treatment incubation (in vitro):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done
- Time after start of exposure: not applicable

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: Varta Cliptrix diagnostic-lamp
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No abnormal findings were observed in the cornea or iris of any animal at any of the measurement intervals. Slight reddening of the conjuctivae was observed in all animals at the 1-hour examination. Slight swelling at the conjuctivae was observed in all animals at 1-hour examination. Slight reddening of the sclerae was present in all animals at 1-hour post instillation. Slight ocular discharge was noted in all animals at the 1-hour examination. All finding were fully reversible within 24 hours after treatment.
Other effects:
- Lesions and clinical observations: All finding were fully reversible within 24 hours.
- Ophthalmoscopic findings: Slight reddening of the conjuctivae, slight swelling at the conjuctivae
- Histopathological findings: Not examined
- Effects of rinsing or washing: No washing performed
Interpretation of results:
GHS criteria not met
Conclusions:
In the eye irritation study, conducted according to appropriate OECD test guideline and in compliance with GLP, the test substance was reported to be not irritating to eyes.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In the key skin irritation study, conducted according to appropriate OECD test guidelines and in compliance with GLP, the test material was reported to be not irritating to skin (RCC, 2004).

Following a 4-hour dermal application on clipped flanks of 3 rabbits, skin reactions were evaluated at 24, 48 and 72 hours after patch removal. The mean erythema scores for each animal were calculated to be 0.33, 0.33 and 0.67, respectively. The mean oedema score was 0.0 for all the animals. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals. No clinical signs of toxicity were noted in any of the animals.

In the key eye irritation study, conducted according to appropriate OECD test guideline and in compliance with GLP, the test material was reported to be not irritating to eyes (RCC, 2004).

Following a single instillation of 0.1 mL of undiluted test substance to the eyes of 3 rabbits, no abnormal findings were observed in the cornea or iris of any animal at any of the measurement intervals. Slight reddening and swelling of the conjunctivae, slight reddening of the sclerae and slight ocular discharge were observed in all animals at the 1-hour examination. All finding was fully reversible within 24 hours after treatment. The individual mean scores from the observations at 24, 48 and 72 hours for corneal opacity, iris, conjunctivae or chemosis were 0.0 for all the animals.

Justification for classification or non-classification

Based on the available data for the submission substance, no classification is required for skin and eye irritation according to Regulation (EC) No 1272/2008.