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EC number: 279-505-5 | CAS number: 80584-91-4
Endpoint summary
Administrative data
Description of key information
Conclusion: The test article caused slight ocular reactions below the level of regulatory significance and is therefore considered as not irritating.
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:
- 11.3.80 - 14.3.80
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions. No analytical purity of the test substance was given. The animals were treated on intact and abraded skin for 24 h under occlusive conditions, and no reading was performed after 48 h.
- Qualifier:
- according to guideline
- Guideline:
- other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (adopted 2002)
- Deviations:
- yes
- Remarks:
- Six animals were used (intact and abraded skin); 24 h treatment under occlusive conditions; No reading after 48 hours
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Californian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hylyne Commercial Rabbits Ltd.
- Age at study initiation: 12-16 weeks
- Average weight at study initiation: 2.41 kg (males), 2.21 kg (females)
- Housing: single housing
- Diet: commercial diet (Labsure, Christopher Hill Group), ad libitum
- Water: sterile filtered water, ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 ± 1
- Humidity (%): 50-70
- Photoperiod: artificial light from 08.00-18.00 hours. - Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved, intact and abraded skin
- Vehicle:
- other: Polyethylene glycol (50% aqueous solution)
- Controls:
- not specified
- Amount / concentration applied:
- 1 mL (corresponding to 500 mg test substance)
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 14 days intended, however study was terminated after 72 h because of negative results
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: back, 2.5 cm x 2.5 cm
- % coverage: 10%
- Type of wrap if used: gauze pad covered with aluminum foil (covered by "COBAN" self adhesive bandage)
REMOVAL OF TEST SUBSTANCE
- Washing: no
- Time after start of exposure: 24 h
SCORING SYSTEM:
Draize scheme
SCORING TIME POINTS:
24 h: directly after patch removal
72 h: 48 h after patch removal - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- intact skin
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- intact skin
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- intact skin
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- intact skin
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- abraded skin
- Time point:
- 24 h
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- abraded skin
- Time point:
- 72 h
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- abraded skin
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- abraded skin
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No dermal reactions were recorded when tested on intact skin, all scores for erythema and edema were zero in all six animals. One animal showed minimal redness after 24 hours (score = 1) when treated on abraded skin, reversible within 72 hours.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- The test article did not cause any signs of irritation when applied occlusively for 4 hours to the intact rabbit skin.
- Executive summary:
The test article's potential to cause dermal irritation was assessed with an in vivo irritation study performed with six Californian rabbits. All animals were treated occlusively with 500 mg test material for 24 hours on either intact or abraded skin. The dermal reactions were recorded after 24 and 72 hours. All scores for erythema and edema were zero in all animals at all time points when treated on intact skin. Similar results were observed on abraded skin, only one animal showed minimal erythema formation at the 24 hour time point reversible within 72 hours. Therefore, based on the result of this study, the test article is not considered to be a skin irritant.
Reference
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
- Study period:
- 11.3.80 - 14.3.80
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions. No data on purity.
- Qualifier:
- according to guideline
- Guideline:
- other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (adopted 2002)
- Deviations:
- yes
- Remarks:
- Six rabbits were used (in 3 rabbits eyes were washes 30 seconds after instillation of test substance).
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Californian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hylyne Commercial Rabbits Ltd.
- Age at study initiation: 12-16 weeks
- Average weight at study initiation: 2.41 kg (males), 2.21 kg (females)
- Housing: single housing
- Diet: commercial diet (Labsure, Christopher Hill Group); ad libitum
- Water: sterile filtered water; ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 ± 1
- Humidity (%): 50-70
- Photoperiod: Artificial light from 08.00-18.00 hours. - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: right untreated eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 100 mg - Duration of treatment / exposure:
- 3 rabbits: single application, washing after 30 seconds with 200 mL warm water.
3 rabbits: single application, no washing was performed - Observation period (in vivo):
- 72 hours (termination of study because of negative results after 72 h)
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- PERFORMED OBSERVATIONS:
- 1, 24, 48, and 72 hours after instillation of test substance
REMOVAL OF TEST SUBSTANCE
- Washing:
3 rabbits: single application, washing with 200 mL warm water
3 rabbits: single application, no washing was performed
- Time after start of exposure: 30 seconds
SCORING SYSTEM:
Draize score
TOOL USED TO ASSESS SCORE:
Fluorescein for assessment of corneal damage. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: unwashed eyes
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: unwashed eyes
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.9
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: unwashed eyes
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: unwashed eyes
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: washed eyes
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: washed eyes
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.4
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: washed eyes
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: washed eyes
- Irritant / corrosive response data:
- Very slight conjunctival reactions (redness and chemosis) were seen in 3/3 washed eyes and slight to mild reactions in 3/3 unwashed eyes one hour after compound application, reversible within 72 hours. Slight corneal opacity with damage to the surface epithelium was seen in 3/3 unwashed eyes at one hour, fully reversible within 48 hours the latest. No effects on the iris were observed in the eyes of the animals.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- The test article caused slight ocular reactions below the level of regulatory significance and is therefore considered as not irritating.
- Executive summary:
The test article's potential to induce ocular irritation was investigated in six Californian rabbits. 100 mg of the test material was instilled into the left eye of each animal and ocular reactions were assessed according to the Draize scoring scheme after 1, 24, 48 and 72 hours. The eyes of three rabbits were washed 30 seconds after substance application while the other three eyes were not rinsed. The test material caused minimal to slight swelling and reddening of the conjunctiva in all six animals, with slightly increased severity in the unrinsed eyes. These effects were reversible back to normal within 72 hours the latest. Additionally, in the unrinsed eyes minimal effects to the cornea were observed, which was fully reversible within 48 hours in all animals. No other effects were observed. Based on these results, and under the test conditions chosen here, the test article is not considered to be irritating to the rabbit eye and does not require classification.
Reference
Table 1: Individual and average irritation scores 1, 24, 48, and 72 hours after instillation of test substance (unwashed eyes)
Rabbit #
|
Time [h]
|
conjunctivae
|
iris
|
cornea
|
|
conjunctivae
|
iris
|
cornea
|
||
redness |
swelling |
redness |
swelling |
|||||||
1
|
1 |
2 |
2 |
0 |
1 |
|
||||
24 |
2 |
1 |
0 |
1 |
||||||
48 |
1 |
0 |
0 |
0 |
||||||
72 |
0 |
0 |
0 |
0 |
||||||
average |
1 |
0.3 |
0 |
0.3 |
Time to reversion |
72 h |
48 h |
- |
48 h |
|
2
|
1 |
2 |
2 |
0 |
1 |
|
|
|||
24 |
1 |
0 |
0 |
0 |
||||||
48 |
1 |
0 |
0 |
0 |
||||||
72 |
0 |
0 |
0 |
0 |
||||||
average |
0.7 |
0 |
0 |
0 |
Time to reversion |
72 h |
24 h |
- |
24 h |
|
3
|
1 |
2 |
1 |
0 |
0 |
|
|
|||
24 |
2 |
2 |
0 |
0 |
||||||
48 |
1 |
0 |
0 |
0 |
||||||
72 |
0 |
0 |
0 |
0 |
||||||
average |
1 |
0.7 |
0 |
0 |
Time to reversion |
72 h |
48 h |
- |
- |
|
average score |
1 |
2 |
1.6 |
0 |
0 |
|
||||
24 |
1.6 |
1 |
0 |
0.3 |
||||||
48 |
1.0 |
0 |
0 |
0 |
||||||
72 |
0 |
0 |
0 |
0 |
||||||
24+48+72 |
0.9 |
0.3 |
0.0 |
0.1 |
||||||
Table 2: Individual and average irritation scores 1, 24, 48, and 72 hours after instillation of test substance (washed eyes)
Rabbit #
|
Time [h]
|
conjunctivae
|
iris
|
cornea
|
|
conjunctivae
|
iris
|
cornea
|
||
redness |
swelling |
redness |
swelling |
|||||||
4
|
1 |
1 |
1 |
0 |
0 |
|
||||
24 |
1 |
0 |
0 |
0 |
||||||
48 |
1 |
0 |
0 |
0 |
||||||
72 |
0 |
0 |
0 |
0 |
||||||
average |
1 |
0.3 |
0 |
0.3 |
Time to reversion |
72 h |
24 h |
- |
48 h |
|
5
|
1 |
1 |
1 |
0 |
0 |
|
|
|||
24 |
0 |
0 |
0 |
0 |
||||||
48 |
0 |
0 |
0 |
0 |
||||||
72 |
0 |
0 |
0 |
0 |
||||||
average |
0.7 |
0 |
0 |
0 |
Time to reversion |
24 h |
24 h |
- |
- |
|
6
|
1 |
1 |
1 |
0 |
0 |
|
|
|||
24 |
1 |
0 |
0 |
0 |
||||||
48 |
1 |
0 |
0 |
0 |
||||||
72 |
0 |
0 |
0 |
0 |
||||||
average |
1 |
0.7 |
0 |
0 |
Time to reversion |
72 h |
24 h |
- |
- |
|
average score |
1 |
1 |
1.0 |
0 |
0 |
|
||||
24 |
0.7 |
0 |
0 |
0 |
||||||
48 |
0.7 |
0 |
0 |
0 |
||||||
72 |
0 |
0 |
0 |
0 |
||||||
24+48+72 |
0.4 |
0 |
0 |
0 |
||||||
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
key study
Justification for selection of eye irritation endpoint:
key study
Conclusion: The test article caused slight ocular reactions below the level of regulatory significance and is therefore considered as not irritating.
Justification for classification or non-classification
According to the criteria of Regulation (EC) No.: 1272/2008, the substance is not classified with regard to Skin corrosion/Irritation and Serious damage to eyes/eye irritation. Also, according to the criteria specified by Directive 67/548/EEC the substance is not classified with regard to these hazard classes.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
