Registration Dossier
Registration Dossier
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EC number: 205-860-2 | CAS number: 156-60-5
Endpoint summary
Administrative data
Description of key information
Skin Irritation: Equivalent or similar to OECD 404; rabbit; not an irritant. Reliability = 2
Eye Irritation: Equivalent or similar to OECD 405; rabbit; irritating. Reliability = 1
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- animals exposed for 24 hours
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: rabbits weighed from 2942 to 3217 grams on the day of treatment
- Housing: housed singly in suspended, stainless steel, wire-mesh cages
- Diet: Purina Certified Rabbit Chow® #5322, ad libitum
- Water: ad libitum
- Acclimation period: approximately 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): targeted for a temperature of 20°C ± 2°C
- Humidity (%): 50% ± 10%
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL aliquot - Duration of treatment / exposure:
- Approximately 24 hours
- Observation period:
- 24, 48 and 72 hours after application of the test substance
- Number of animals:
- 1 female and 5 male
- Details on study design:
- TEST SITE
- Area of exposure: approximately one square inch
- % coverage: 100%
- Type of wrap if used: A 1-inch gauze square was held in place with tape. Rubber sheeting was then wrapped around the animal and secured with clips to retard evaporation and to keep the test substance in contact with the skin without undue pressure.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Basis:
- other: range
- Time point:
- other: 1 hour to 72 hours
- Score:
- > 1 - <= 3
- Max. score:
- 4
- Reversibility:
- other: 4 of 6 animals had score of 2 at 72 hours
- Irritation parameter:
- edema score
- Basis:
- other: range
- Time point:
- other: 1 hour to 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 1
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- 3
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 2
- Irritant / corrosive response data:
- By 24 hours following application of the test substance, no to mild erythema was observed in the treated rabbits. At 48 hours, no to moderate erythema was observed. No or mild erythema was observed at 72 hours. No edema was observed throughout the study.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- This study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
Under the conditions of this study, the test substance is not a skin irritant. - Executive summary:
The test substance was evaluated for acute skin irritation potential in 1 female and 5 male rabbits. A 0.5 mL aliquot was applied to the clipped test site then covered with gauze and rubber sheeting. After 24 hours the test site was washed then scored according to the Draize scale. Erythema was observed in 5 of the 6 animals. Draize scores ranged from 0 to 2.3 across 24, 48, and 72 hours. No edema was observed throughout the study.
Reference
Table 1: Individual Animal Dermal Effects |
|||
ERYTHEMA |
|||
Rabbit Number |
Evaluation after Removal of Test Substance |
||
24 Hours |
48 Hours |
72 Hours |
|
22334 |
0 |
2 |
2 |
22337 |
0 |
0 |
2 |
22338 |
2 |
0 |
0 |
22340 |
0 |
0 |
0 |
22341 |
1 |
2 |
2 |
22368 |
2 |
3 |
2 |
|
|||
EDEMA |
|||
Rabbit Number |
Evaluation after Removal of Test Substance |
||
24 Hours |
48 Hours |
72 Hours |
|
22334 |
0 |
0 |
0 |
22337 |
0 |
0 |
0 |
22338 |
0 |
0 |
0 |
22340 |
0 |
0 |
0 |
22341 |
0 |
0 |
0 |
22368 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- one eye washed after 20 seconds
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 2806 and 3289 grams
- Housing: housed singly in suspended, stainless steel, wire-mesh cages
- Diet: Purina Certified Rabbit Chow® #5322 (ad libitum)
- Water: ad libitum
- Acclimation period: approximately 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): targeted for a temperature of 20°C ± 2°C
- Humidity (%): 50% ± 10%
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye of each rabbit was not treated and served as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.01 mL aliquot - Duration of treatment / exposure:
- single exposure
- Observation period (in vivo):
- 1 and 4 hours and 1, 2, and 3 days following administration
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): one rabbit had eyes washed
- Time after start of exposure: 20 seconds
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: biomicroscope, fluorescein, Hemastix® reagent strips - Irritation parameter:
- other: discharge
- Basis:
- other: range
- Time point:
- other: 1 hour to 72 hours
- Score:
- >= 0 - <= 3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: unwashed
- Irritation parameter:
- iris score
- Basis:
- other: range
- Time point:
- other: 1 hour to 72 hours
- Score:
- >= 0 - <= 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: washed eye
- Irritation parameter:
- conjunctivae score
- Basis:
- other: range
- Time point:
- other: 1 hour to 72 hours
- Score:
- >= 0 - <= 2
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: washed eye
- Irritation parameter:
- chemosis score
- Basis:
- other: range
- Time point:
- other: 1 hour to 72 hours
- Score:
- >= 0 - <= 3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: washed eye
- Irritation parameter:
- other: discharge
- Basis:
- other: range
- Time point:
- other: 1 hour to 72 hours
- Score:
- >= 0 - <= 3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: washed eye
- Irritation parameter:
- cornea opacity score
- Basis:
- other: range
- Time point:
- other: 1 hour to 72 hours
- Score:
- >= 0 - <= 4
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: washed eye
- Irritation parameter:
- cornea opacity score
- Basis:
- other: range
- Time point:
- other: 1 hour to 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: unwashed
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- Unwashed Eye
- Time point:
- other: 1 Hour
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- Unwashed Eye
- Time point:
- other: 4 Hours
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- Unwashed Eye
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- Unwashed Eye
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- Unwashed Eye
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- other: range
- Time point:
- other: 1 hour to 72 hours
- Score:
- >= 0 - <= 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: unwashed
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- Unwashed Eye
- Time point:
- other: 1 Hour
- Score:
- 1
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- Unwashed Eye
- Time point:
- other: 4 Hours
- Score:
- 1
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- Unwashed Eye
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- Unwashed Eye
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- Unwashed Eye
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- other: range
- Time point:
- other: 1 hour to 72 hours
- Score:
- >= 0 - <= 2
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: unwashed
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- Unwashed Eye
- Time point:
- other: 1 Hour
- Score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- Unwashed Eye
- Time point:
- other: 4 Hours
- Score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- Unwashed Eye
- Time point:
- 24 h
- Score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- Unwashed Eye
- Time point:
- 48 h
- Score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- Unwashed Eye
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- other: range
- Time point:
- other: 1 hour to 72 hours
- Score:
- >= 0 - <= 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: unwashed
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- Unwashed Eye
- Time point:
- other: 1 Hour
- Score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- Unwashed Eye
- Time point:
- other: 4 Hours
- Score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- Unwashed Eye
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- Unwashed Eye
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- Unwashed Eye
- Time point:
- 72 h
- Score:
- 0
- Irritant / corrosive response data:
- The test substance produced severe corneal opacity in the washed eye. In addition, it produced moderate iritis and conjunctival redness and copious blood-tinged discharge (confirmed with Hemastix® reagent strips) in both treated eyes, and moderate and mild chemosis in the washed and unwashed eye, respectively. Fluorescein stain examinations were positive for corneal injury in the washed eye and negative in the unwashed eye. Biomicroscopic examinations revealed moderate to severe corneal injury in the washed eye and no corneal injury in the unwashed eye. The treated eyes of both rabbits were normal by 3 days after treatment.
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- This study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
Under the conditions of this study, the test item was an eye irritant. - Executive summary:
The test substance was evaluated for acute eye irritation potential in 2 young adult New Zealand white rabbits. An aliquot of 0.01 mL of the test substance was administered to 1 eye of each animal. The eyes of one rabbit were washed following treatment. The untreated eye served as a control. The conjunctiva, iris, and cornea of each treated eye were evaluated and scored according to the Draize scale approximately 1 and 4 hours and 1, 2, and 3 days following administration.
The substance produced severe corneal opacity in the washed eye. In addition it produced moderate iritis and conjunctival redness and copious blood-tinged discharge (confirmed with Hemastix® reagent strips) in both treated eyes, and moderate and mild chemosis in the washed and unwashed eye, respectively. Fluorescein stain examinations were positive for corneal injury in the washed eye and negative in the unwashed eye. Biomicroscopic examinations revealed moderate to severe corneal injury in the washed eye and no corneal injury in the unwashed eye. The treated eyes of both rabbits were normal by 3 days after treatment. Under the conditions of this study, the test item was an eye irritant.
Reference
Unwashed Rabbit Eye |
|||||
Time |
1 Hour |
4 Hours |
1 Day |
2 Days |
3 Days |
Corneal Opacity |
0 |
0 |
0 |
0 |
0 |
Iris |
1 |
1 |
0 |
0 |
0 |
Redness |
1 |
2 |
2 |
1 |
0 |
Chemosis |
2 |
2 |
0 |
0 |
0 |
Discharge |
3(H+) |
2(H+) |
0 |
0 |
0 |
Biomic of Cornea |
- |
- |
0 |
0 |
0 |
H+ = Hemastix® evaluation positive for blood. |
|||||
Fluorescein examinations: negative for corneal injury at all intervals |
|||||
Washed Rabbit Eye |
|||||
Time |
1 Hour |
4 Hours |
1 Day |
2 Days |
3 Days |
Corneal Opacity |
1 |
2 |
4 |
1 |
0 |
Iris |
1 |
1 |
1 |
0 |
0 |
Redness |
1 |
2 |
2 |
1 |
0 |
Chemosis |
3 |
3 |
1 |
1 |
0 |
Discharge |
3(H+) |
3(H+) |
0 |
0 |
0 |
Biomic of Cornea |
- |
- |
4 |
2 |
0 |
H+ = Hemastix® evaluation positive for blood. |
|||||
Fluorescein examinations: positive for corneal injury 1 day after treatment. |
|||||
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
An aliquot of 0.01 mL of the test substance was administered to one eye of a rabbit. The untreated eye served as a control. The conjunctiva, iris, and cornea of each treated eye were evaluated and scored according to the Draize scale approximately 1 and 4 hours and 1, 2, and 3 days following administration. Iritis, conjunctival redness, blood-tinged discharge, and chemosis were observed in the treated eye. The treated eyes were normal by 3 days after treatment.
The test substance was evaluated for acute skin irritation potential in 1 female and 5 male rabbits. A 0.5 mL aliquot was applied to the clipped test site then covered with gauze and rubber sheeting. After 24 hours the test site was washed then scored according to the Draize scale. Erythema was observed in 5 of the 6 animals. Draize scores ranged from 0 to 2.3. No edema was observed throughout the study.
Justification for selection of skin irritation / corrosion endpoint:
Equivalent or similar to OECD Guideline
Justification for selection of eye irritation endpoint:
Equivalent or similar to OECD Guideline
Effects on eye irritation: irritating
Justification for classification or non-classification
Draize score for skin irritation was 0 to 2.3, therefore no classification is required for skin irritation according to the EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
The test substance produced corneal opacity, iritis, conjunctival redness, and discharge, which cleared by 3 days after treatment. Therefore, the test substance is classified Cat 2 (H319: Causes serious eye irritation) according to EU Classification, Labelling, and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 and Xi; R36 (irritating to eyes) according to EU Directive 67/548/EEC.
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