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EC number: 947-930-1 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Effects on skin irritation/corrosion:slightly irritating.
However, not sufficient for classification under GHS
Effects on eye irritation:moderately irritating. However, not
sufficient for classification under GHS
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-05-22 to 2003-05-25
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- New Zealand Albino, one male 2 female young adults. They were housed singly. Temperature 20-22 C with 12/12 hour light/dark cycle.
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL to 6cm2 per animal
- Duration of treatment / exposure:
- After 4 hours the pads and collars were removed and the test sites cleansed of any residue substance
- Observation period:
- 1, 24, 48 and 72 hours after removal of patch
- Number of animals:
- 3
- Details on study design:
- Individual dose sites were scored according to the Draize scoring system. The classification of irritancy was obtained by adding the average erythema and edema scores for the 1, 24, 48 and 72-hour scoring intervals and dividing by the number of evaluation intervals (4). The resulting Primary Dermal Irritation Index (PDII) was classified as follows:
0 - Non-irritiating
>0-2.0 - Slightly irritating
2.1-5.0 - Moderately irritating
>5.0 - Severely irritating - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- no data
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Primary Dermal Irritation Index
- Conclusions:
- Under the conditions of this study, the test substance is classified as slightly irrritating to the skin.
- Executive summary:
3 New Zealand Albino rabbits had 0.5mL of the test substance topically applied to a clipped 6cm2 area of skin which was then covered semi-occlusively for 4 hours. No edema was noted for any treated site during the study.
At one and 24 hours after the patch removal slight erythema was evident at all 3 treated sites in all animals. All animals were free from dermal irritation at 48 hours. The Primary Dermal Irritation Index was 0.5. Under the conditions of this study, the test substance is classified as slightly irrritating to the skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-05-29 to 2003-06-01
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- New Zealand Albino, three male young adults. They were housed singly. Temperature 18-22 C with 12/12 hour light/dark cycle
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 mL was instilled into the conjunctival sac of the right eye of 3 healthy rabbits by pulling the lower lid way from the eyeball. The upper and lower lids were then gently held together for about one second before releasing to minimise loss of the test subtsance. The left eye remained untreated and served as a control.
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 1, 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Ocular irritation was evaluated using a high-intensity white ligh in accordance with Draize et al. at 1, 24, 48 and 72 hours post-installation. The time interval with the highest mean score (Maximum Mean Total Score - MMTS) for all rabbits was used to classify the test substance by the system of Kay and Calandra.
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 13.3
- Max. score:
- 110
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 13.3
- Max. score:
- 110
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 13.3
- Max. score:
- 110
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 80
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 80
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 80
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 1h
- Score:
- 14
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 10
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 4
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 1h
- Score:
- 14
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 10
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 4
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 1 h
- Score:
- 12
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 10
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 4
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Executive summary:
0.1 mL of the test substance was instilled into the right eye of 3 healthy rabbits by pulling the lower lid way from the eyeball. The upper and lower lids were then gently held together for about one second before releasing to minimise loss of the test subtsance. The left eye served as a control. Occular irritation was evaluated by the Draize et al. method. Ocular irritation was evaluated using a high-intensity white ligh in accordance with Draize et al. at 1, 24, 48 and 72 hours post-installation. The time interval with the highest mean score (Maximum Mean Total Score - MMTS) for all rabbits was used to classify the test substance by the system of Kay and Calandra.
All animals appeared active and healthy. Apart from the eye irritation described below, there were no signs of gross toxicity, adverse phamacologic effects or abnormal behaviour.
No corneal opacity ot iritis was noted for any treated eye during the study. One hour after test substance installation, all three treated eyes exhibited conjunctivitis. The overall severity of irritation decreased with time. All animals were free of occular irritiation within 72 hours.
The Maximum Mean Total Score was 13.3 and is therefore classified as mildly irritating to the eye under these study conditions.
Reference
Incidence of Irritation
|
| Time Post Instillation (Hours) | Severity of Irritation - Mean Score |
| 1 | 13.3 |
| 24 | 10.0 |
| 48 | 4.0 |
| 72 | 0.0 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Effects on eye irritation: moderately irritating. However, not sufficient for classification under GHS
Justification for classification or non-classification
Effects on skin irritation/corrosion:slightly irritating.
However, not sufficient for classification under GHS
Effects on eye irritation:moderately irritating. However, not
sufficient for classification under GHS
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