Registration Dossier

Administrative data

Description of key information

Skin irritation according to OECD 404: No corrosion no irritation.

Eye irritation according to OECD 405: average scores do not warrant classification.

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)
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Moston, Cheshire, UK.
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2000 - 3500 g
- Housing: Metal Cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


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


Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:
4 hours
Observation period:
24, 48 and 72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: Shorn Skin
- Type of wrap if used: Elasticated corset and surgical adhesive


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Gentle swabbing with cotton wool soaked in distilled water



SCORING SYSTEM: Draize scoring system
0: Non-irritant
>0–2: mild irritant
>2–5: Moderate irritant
>5–8: Severe irritant
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Other effects:
None
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Conclusions:
The test material produced a primary irritation index of 0.0 and was classified as NON-IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
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 (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Moston, Cheshire, UK.
- Age at study initiation: 12 - 20 weeks
- Weight at study initiation: 2000 - 3500 g
- Housing: Suspended metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


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


Vehicle:
unchanged (no vehicle)
Controls:
other: The left was used for control purposes
Amount / concentration applied:
Amount applied: 0.1 ml
Observation period (in vivo):
after 1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
Not rinsed


SCORING SYSTEM: Draize Scoring System


TOOL USED TO ASSESS SCORE: Standard opthalmoscope
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 24 hrs
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 24 hrs
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 24 hrs
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 24 hrs
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 24 hrs
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 48 hrs
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 hrs
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 hrs
Irritant / corrosive response data:
Dulling of the normal lustre of the cornea was noted in one treated eye one hour after treatment. Scattered or diffuse areas of corneal opacity were noted in two treated eyes 24 hours after treatment. Iridial inflammation was noted in all treated eyes 1 and 24 hours after treatment. Moderate conjunctival irritation was noted in all treated eyes 1, 24 and 48 hours after treatment with minimal conjunctival irritation noted 72 hours after treatment.

AVERAGE SCORE (24,48,72 hours) per animal 1 / 2 / 3
- Cornea: 0.0 / 0.3 / 0.3
- Iris: 0.3 / 0.3 / 0.3
- Conjuntivae (Redness): 1.7 / 1.7 / 1.7
- Conjuntivae (Chemosis): 0.7 / 1.0 / 1.0

All treated eyes appeared normal after 7 days.

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Conclusions:
The test material produced a maximum group mean score of 24.3 and was classified as a MODERATE IRRITANT (CLASS 5 ON A 1 TO 8 SCALE) to the rabbit eye according to a modified Kay and Calandra classification system. The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation study was performed according to or according to OECD 404. The test material produced a primary irritation index of 0.0 and was classified as NON-IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

Eye irritation study was performed according to or according to OECD 405. The test material produced a maximum group mean score of 24.3 (Draize) and was classified as a MODERATE IRRITANT (CLASS 5 ON A 1 TO 8 SCALE) to the rabbit eye according to a modified Kay and Calandra classification system.

Justification for classification or non-classification

No irritation was observed in a OECD 404 type study and no classification is warranted for skin irritation.

Slight irritation of the eye was observed in a OECD 405 study. The effects do not warrant a classification as irritant.