Registration Dossier
Registration Dossier
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EC number: 911-254-5 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Skin irritation: Key study: Experimental result: Test according to OECD guideline 404 and EU method B.4. GLP study.
The results obtained, under these experimental conditions, enable to conclude that the test item is irritant to skin.
Skin irritation: Data waiving: An in vitro study does not need to be conducted since adequate data from an in vivo skin irritation study are available.
Eye irritation: Key study: Experimental result: Test according to OECD guideline 405 and EU method B.5. GLP study.
The results obtained, under these experimental conditions, enable to conclude that the test item is irritating to eyes.
Eye irritation: Data waiving: An in vitro study does not need to be conducted since adequate data from an in vivo eye irritation study are available.
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:
- Between 26 January 2010 and 16 February 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Meets the requirements of GLP. There are no deviations from the recommended guideline.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gérome (Quartier Labaste -F40260 Linxe)
- Age at study initiation: 11 or 12 weeks old
- Weight at study initiation: between 2.42 kg and 2.62 kg
- Housing: individual box installed in conventional air conditioned animal husbanding
- Diet (e.g. ad libitum): foodstuff (SDS - CI5) was supplied freely.
- Water (e.g. ad libitum): Drinking water (tap-water from public distribution system) was supplied freely.
- Acclimation period: minimum 5-day acclimatization period
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): approximately fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (07.00 to 19.00) and twelve hours darkness - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- 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 - Duration of treatment / exposure:
- 4 hours
- Observation period:
- The skin reactions were appreciated 1 hour and then 24, 48 and 72 hours after removal of the patch.
If no reaction is observed 72 hours after the treatment, the study is terminated. In case of persistent reactions, additional observations can be carried out from D4 to D14 in order to determine the reversible character of the lesions observed. - Number of animals:
- 3 male
- Details on study design:
- TEST SITE
- Area of exposure: about 6 cm2 per patch
- Type of wrap if used: the patch was secured in position with a strip of surgical adhesive tape under semi-occlusive dressing.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): after the removal of the patch, the treated area was rinsed with distilled water.
SCORING SYSTEM: Erythema and Eschar formation (0 to 4) and Oedema (0 to 4) - Irritation parameter:
- erythema score
- Remarks:
- (and eschar)
- Basis:
- animal #1
- Remarks:
- animal A9980
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- erythema score
- Remarks:
- (and eschar)
- Basis:
- animal #2
- Remarks:
- animal A9981
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- erythema score
- Remarks:
- (and eschar)
- Basis:
- animal #3
- Remarks:
- animal A9982
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- animal A9980
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- animal A9981
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- animal A9982
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Interpretation of results:
- other: skin irritant (Cat 2) (CLP Regulation EC no. 1272/2008)
- Conclusions:
- The results obtained, under these experimental conditions, enable to conclude that the test item is irritant to skin.
- Executive summary:
The test item was applied, as supplied, at the dose of 0.5 mL, under semi-occlusive dressing during 4 hours on an undamaged skin area of 3 rabbits. The experimental protocol was established from the O.E.C.D. guideline n° 404 and the test method B.4 of the Council regulation No 440/2008. A well defined to moderate erythema, associated with a slight to moderate oedema, was noted on the treated area of three animals, 1 hour after the patch removal. The oedematous and erythematous reactions were totally reversible between day 4 and day 5. On the cutaneous structure, slight dryness to roughness was noted from day 2 or day 3 and was totally reversible between day 9 and day 14. The results obtained, under these experimental conditions, enable to conclude that the test item is irritant to skin.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
An in vitro study does not need to be conducted since adequate data from an in vivo skin irritation study are available.
Referenceopen allclose all
A well defined to moderate erythema, associated with a slight to moderate oedema, was noted on the treated area of three animals, 1 hour after the patch removal. The oedematous and erythematous reactions were totally reversible between day 4 and day 5. On the cutaneous structure, slight dryness to roughness was noted from day 2 or day 3 and was totally reversible between day 9 and day 14.
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:
- Between 22 February 2010 and 11 March 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Meets the requirements of GLP. There are no deviations from the recommended guideline.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gérome (Quartier Labaste - F40260 Linxe)
- Age at study initiation: 12 or 13 weeks old
- Weight during the test: between 2.53 kg and 3.38 kg
- Housing: individual box installed in conventional air conditioned animal husbanding
- Diet (e.g. ad libitum): foodstuff (SDS - C15) was supplied freely
- Water (e.g. ad libitum): Drinking water (tap-water from public distribution system) was supplied freely
- Acclimation period: minimal 5-day acclimatisation period
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): approximately fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (07.00 to 19.00) and twelve hours darkness - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Exposure: one instillation
- Observation period (in vivo):
- Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following treatment.
If no reaction is obsetyed 72 hours after instillation, the study is terminated. In case of persistent reactions, additional obsetvations can be carried out from D4 to D21 in order to determine the reversible character of the lesions observed. - Number of animals or in vitro replicates:
- 3 female animals
- Details on study design:
- SCORING SYSTEM: Eye examinations are carried out using the scale of lesion scores In the following order: chemosis, discharge, redness, iris, cornea (degree and extent of opacity).
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- animal A0016
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- animal A0022
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- animal A0024
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- animal A0016
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 11 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- animal A0022
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- animal A0024
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- iris score
- Remarks:
- lesion
- Basis:
- animal #1
- Remarks:
- animal A0016
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- iris score
- Remarks:
- lesion
- Basis:
- animal #2
- Remarks:
- animal A0022
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- iris score
- Remarks:
- lesion
- Basis:
- animal #3
- Remarks:
- animal A0024
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #1
- Remarks:
- animal A0016
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #2
- Remarks:
- animal A0022
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #3
- Remarks:
- animal A0024
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Interpretation of results:
- other: Eye irritant (Cat 2) (CLP Regulation EC no. 1272/2008)
- Conclusions:
- In conclusion, the results obtained, under these experimental conditions, enable to conclude that the test item is irritating to eyes.
- Executive summary:
The test item was instilled as supplied, into the eye of threeNew Zealandrabbits at the dose of 0.1 mL. The experimental protocol was established on the basis of the official method as defined in the O.E.C.D. guideline n° 405 and the test method B.5 of the council regulation n° 440/2008. The ocular reactions observed during the study have been moderate and totally reversible:
- at the conjunctivae level: a moderate redness noted 1 hour after the test item instillation and totally reversible between days 10 and 11 associated with a moderate chemosis noted 24 hours after the test item instillation and totally reversible between days 8 and 10.
- at the iris level: a congestion, noted 24 hours after the test item instillation, and totally reversible between days 2 and 7.
- at the corneal level: a moderate corneal opacity, noted 24 hours after the test item instillation, and totally reversible at day 7.
Furthermore, a corneal neovascularisation was noted at day 1 in one animal, between day 1 and day 3 in a second animal and between day 2 and day 8 in the last one.
In conclusion, the results obtained, under these experimental conditions, enable to conclude that the test item is irritating to eyes.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
An in vitro study does not need to be conducted since adequate data from an in vivo eye irritation study are available.
Referenceopen allclose all
The ocular reactions observed during the study have been moderate and totally reversible:
- at the conjunctivae level: a moderate redness noted 1 hour after the test item instillation and totally reversible between days 10 and 11 associated with a moderate chemosis noted 24 hours after the test item instillation and totally reversible between days 8 and 10.
- at the iris level: a congestion, noted 24 hours after the test item instillation, and totally reversible between days 2 and 7.
- at the corneal level: a moderate corneal opacity, noted 24 hours after the test item instillation, and totally reversible at day 7.
Furthermore, a corneal neovascularisation was noted at day1 in one animal, between day 1 and day 3 in a second animal and between day 2 and day 8 in the last one.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation: Key study: Experimental result: Test according to OECD guideline 404 and EU method B.4.
The test item was applied at the dose of 0.5 mL, under semi-occlusive dressing during 4 hours on an undamaged skin area of 3 rabbits. The results obtained, under these experimental conditions, enable to conclude that the test item is irritant to skin.
Skin irritation: Data waiving: An in vitro study does not need to be conducted since adequate data from an in vivo skin irritation study are available.
Eye irritation: Key study: Experimental result: Test according to OECD guideline 405 and EU method B.5.
The test item was instilled into the eye of threeNew Zealandrabbits at the dose of 0.1 mL. The results obtained, under these experimental conditions, enable to conclude that the test item is irritating to eyes.
Eye irritation: Data waiving: An in vitro study does not need to be conducted since adequate data from an in vivo eye irritation study are available.
Justification for selection of skin irritation / corrosion endpoint:
Only one study available. Klimisch 1. This study was carried out in accordance with internationally valid GLP principles.
Justification for selection of eye irritation endpoint:
Only one study available. Klimisch 1. This study was carried out in accordance with internationally valid GLP principles.
Effects on skin irritation/corrosion: irritating
Effects on eye irritation: irritating
Justification for classification or non-classification
Based on the results observed in the skin irritation study, the substance is classified as "Skin irritant Category 2".
Based on the results observed in the eye irritation study, the substance is classified as "Eye irritant Category 2".
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.
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