Registration Dossier
Registration Dossier
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EC number: 814-233-8 | CAS number: 444649-70-1
Endpoint summary
Administrative data
Description of key information
The test substance is not considered to be irritating to skin and eyes.
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:
- From May 14, 2001 to May 18, 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Batch no.: F016143 05
Appearance: Light-yellow, clear viscous liquid - Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- females
- Details on test animals or test system and environmental conditions:
- Source: Charles River Wiga, D-97633
Acclimatization: 5 days
Body weight: 2.0-2.4 kg
Temperature: ca. 20.3°C, relative humidity : ca. 58.8% and light regimen: 12-hour light /12-hour dark cycle
Diet: laboratory food Altromin 2123, ad libitum
Water: tap water for human consumption, ad libitum - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 1, 24, 48 and 72 h after patch removal
- Number of animals:
- 3
- Details on study design:
- - Hair was clipped on the dorsal areas of the trunks one day before the application of the test substance. The test sites were median on the dorsal thoracal region. 0.5 mL of the test substance was applied via a cellulose patch to a site of about 2.5 cm x 2.5 cm of the intact skin of each of 3 rabbits and covered by a semi-occlusive dressing.
- The skins were examinated for local alterations one day before the administration of the test substance (after clipping of the hair) and immediately before the administration. The treated areas and the surrounding untreated skin (control area) of the animals were examinated (using a cold light source KL 1500 electronic) for erythema/eschar and oedema as well as for other local alterations approximately 1, 24, 48 and 72h after patch removal. The animals were analysed once daily.
- Primary irritation index was calculated according to EPA: all scores for erythema and oedema for the 3 animals and the 4 reading times were added and divided by 12. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Max. score:
- 0
- Reversibility:
- other: no effects were seen
- Remarks:
- no effects were seen
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Max. score:
- 0
- Reversibility:
- other: no effects were seen
- Remarks:
- no effects were seen
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Max. score:
- 0
- Reversibility:
- other: no effects were seen
- Remarks:
- no effects were seen
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Max. score:
- 0
- Reversibility:
- other: no effects were seen
- Remarks:
- no effects were seen
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Max. score:
- 0
- Reversibility:
- other: no effects were seen
- Remarks:
- no effects were seen
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Max. score:
- 0
- Reversibility:
- other: no effects were seen
- Remarks:
- no effects were seen
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- All exposed skin sites were normal at each examination term; neither erythema/eschar nor oedema were observed. The primary irritation index was 0.0. The test substance was considered not irritating to the skin.
- Other effects:
- No general toxic effects of the test substance were observed.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- does not need to be classified
- Conclusions:
- Under the study conditions, the test substance was considered not irritating to rabbit skin.
- Executive summary:
An in vivo study was conducted to determine the skin irritation potential of the test substance according to OECD Guideline 404, EU Method B.4 and EPA-Guideline OPPTS 870.2500, in compliance with GLP. Hair of 3 female rabbits (New-Zealand White) was clipped on the dorsal areas of the trunks one day before the application of the test substance. 0.5 mL of the test substance was applied via a cellulose patch to a site of about 2.5 cm x 2.5 cm of the intact skin of each of 3 rabbits and covered by a semi-occlusive dressing. The skins were examined for local alterations one day before the administration of the test substance (after clipping of the hair) and immediately before the administration. The treated areas and the surrounding untreated skin (control area) of the animals were examined for erythema/eschar and oedema as well as for other local alterations approximately 1, 24, 48 and 72h after patch removal. The animals were analysed once daily. Primary irritation index was calculated according to EPA: all scores for erythema and oedema for the 3 animals and the 4 reading times were added and divided by 12. No general toxic effects of the test substance were observed. All exposed skin sites were normal at each examination term; neither erythema/eschar nor oedema was observed. The primary irritation index was 0.0. Under the study conditions, the test substance was considered not irritating to the skin (Wolf, 2001).
- 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
- Reason / purpose for cross-reference:
- data waiving: supporting information
Referenceopen allclose all
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:
- From May 14, 2001 to May 25, 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Batch no.: F016143 05
Appearance: Light-yellow, clear viscous liquid - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Source: Charles River Wiga, D-97633
Acclimatization: 5 days
Body weight: 2.1-2.3 kg
Temperature: ca. 20.3°C, relative humidity : ca. 58.8% and light regimen: 12-hour light /12-hour dark cycle
Diet: laboratory food Altromin 2123, ad libitum
Water: tap water for human consumption, ad libitum - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- one application
- Observation period (in vivo):
- 1, 24, 48 and 72h after application
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- - 0.1 mL of the test substance was administered per animal into the conjunctival sacs of the right eyes by gently pulling the lower lids away from the eyeballs for instillation. The eyes were held closed for about one second to prevent loss of the test substance. The left eyes remained untreated and served as a control.
- Both eye were examinated within 24h before the instillation and approximately 1, 24, 48 and 72h after the application. The whole eyes, especially the corneas, the irises and the conjunctivae were examinated using an otoscope lamp.
- Mean data of the eye examination scores of each animal (means of the 24, 48 and 72h) for cornea opacity, iris lesions, conjunctival redness and conjunctival oedema were calculated and were classified according to the EEC Ocular Evaluation Criteria. For each group, ocular scores for each parameter (corneal opacity x area, iritis and conjunctival redness + swelling + discharge) were multiplied by the appropriate factor and totals added for each animals per interval according to the method of Draize. The group mean irritation scores were calculated at each scoring interval. The 24, 48 and 72h mean irritation scores were added and the sum divided by 3 to obtain the overall irritation score.
- In addition, the animals were observed for other than local changes at all observation times. Body weights were rmeasured at the start and at the end of the test. Genral signs of toxicity were recorded once daily. - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Max. score:
- 0
- Reversibility:
- other: no effects were seen
- Remarks:
- no effects were seen
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Max. score:
- 0
- Reversibility:
- other: no effects were seen
- Remarks:
- no effects were seen
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Max. score:
- 0
- Reversibility:
- other: no effects were seen
- Remarks:
- no effects were seen
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Max. score:
- 0
- Reversibility:
- other: no effects were seen
- Remarks:
- no effects were seen
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Max. score:
- 0
- Reversibility:
- other: no effects were seen
- Remarks:
- no effects were seen
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Max. score:
- 0
- Reversibility:
- other: no effects were seen
- Remarks:
- no effects were seen
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Max. score:
- 0
- Reversibility:
- other: no effects were seen
- Remarks:
- no effects were seen
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Max. score:
- 0
- Reversibility:
- other: no effects were seen
- Remarks:
- no effects were seen
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Max. score:
- 0
- Reversibility:
- other: no effects were seen
- Remarks:
- no effects were seen
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Max. score:
- 0
- Reversibility:
- other: no effects were seen
- Remarks:
- no effects were seen
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Max. score:
- 0
- Reversibility:
- other: no effects were seen
- Remarks:
- no effects were seen
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Max. score:
- 0
- Reversibility:
- other: no effects were seen
- Remarks:
- no effects were seen
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- All eyes treated with the test substance were normal before the instillation and at any observation time. The mean scores of all parameters investigated were 0.0 for each animal and the overall irritation score was 0.0 at any observation time. All untreated eyes were normal throughout the test.
- Other effects:
- No general toxic effects of the test substance were observed.
- Interpretation of results:
- other: CLP criteria not met
- Remarks:
- does not need to be classified
- Conclusions:
- Under the study conditions, the test substance was considered not irritating to rabbit eye.
- Executive summary:
An in vivo study was conducted to determine the eye irritation of the test substance according to OECD Guideline 405, EU Method B.5 and EPA OPPTS 870.2400, in compliance with GLP. 0.1 mL of the test substance was administered per rabbit (New-Zealand White females) into the conjunctival sacs of the right eyes by gently pulling the lower lids away from the eyeballs for instillation. The left eyes remained untreated and served as a control. Both eye were examined within 24h before the instillation and approximately 1, 24, 48 and 72h after the application. The whole eyes, especially the corneas, the irises and the conjunctivae were examined. Mean data of the eye examination scores of each animal (means of the 24, 48 and 72h) for cornea opacity, iris lesions, conjunctival redness and conjunctival oedema were calculated and were classified according to the EEC Ocular Evaluation Criteria. For each group, ocular scores for each parameter (corneal opacity x area, iritis and conjunctival redness + swelling + discharge) were multiplied by the appropriate factor and totals added for each animals per interval according to the method of Draize. The group mean irritation scores were calculated at each scoring interval. The 24, 48 and 72h mean irritation scores were added and the sum divided by 3 to obtain the overall irritation score. In addition, the animals were observed for other than local changes at all observation times. Body weights were measured at the start and at the end of the test. General signs of toxicity were recorded once daily. No general toxic effects of the test substance were observed. All eyes treated with the test substance were normal before the instillation and at any observation time. The mean scores of all parameters investigated were 0.0 for each animal and the overall irritation score was 0.0 at any observation time. All untreated eyes were normal throughout the test. Under the study conditions, the test substance was considered not irritating to rabbit eye (Wolf, 2001).
- 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
- Reason / purpose for cross-reference:
- data waiving: supporting information
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
An in vivo study was conducted to determine the skin irritation potential of the test substance according to OECD Guideline 404, EU Method B.4 and EPA-Guideline OPPTS 870.2500, in compliance with GLP. Hair of 3 female rabbits (New-Zealand White) was clipped on the dorsal areas of the trunks one day before the application of the test substance. 0.5 mL of the test substance was applied via a cellulose patch to a site of about 2.5 cm x 2.5 cm of the intact skin of each of 3 rabbits and covered by a semi-occlusive dressing. The skins were examined for local alterations one day before the administration of the test substance (after clipping of the hair) and immediately before the administration. The treated areas and the surrounding untreated skin (control area) of the animals were examined for erythema/eschar and oedema as well as for other local alterations approximately 1, 24, 48 and 72h after patch removal. The animals were analysed once daily. Primary irritation index was calculated according to EPA: all scores for erythema and oedema for the 3 animals and the 4 reading times were added and divided by 12. No general toxic effects of the test substance were observed. All exposed skin sites were normal at each examination term; neither erythema/eschar nor oedema was observed. The primary irritation index was 0.0. Under the study conditions, the test substance was considered not irritating to the skin (Wolf, 2001).
Eye irritation:
An in vivo study was conducted to determine the eye irritation of the test substance according to OECD Guideline 405, EU Method B.5 and EPA OPPTS 870.2400, in compliance with GLP. 0.1 mL of the test substance was administered per rabbit (New-Zealand White females) into the conjunctival sacs of the right eyes by gently pulling the lower lids away from the eyeballs for instillation. The left eyes remained untreated and served as a control. Both eye were examined within 24h before the instillation and approximately 1, 24, 48 and 72h after the application. The whole eyes, especially the corneas, the irises and the conjunctivae were examined. Mean data of the eye examination scores of each animal (means of the 24, 48 and 72h) for cornea opacity, iris lesions, conjunctival redness and conjunctival oedema were calculated and were classified according to the EEC Ocular Evaluation Criteria. For each group, ocular scores for each parameter (corneal opacity x area, iritis and conjunctival redness + swelling + discharge) were multiplied by the appropriate factor and totals added for each animals per interval according to the method of Draize. The group mean irritation scores were calculated at each scoring interval. The 24, 48 and 72h mean irritation scores were added and the sum divided by 3 to obtain the overall irritation score. In addition, the animals were observed for other than local changes at all observation times. Body weights were measured at the start and at the end of the test. General signs of toxicity were recorded once daily. No general toxic effects of the test substance were observed. All eyes treated with the test substance were normal before the instillation and at any observation time. The mean scores of all parameters investigated were 0.0 for each animal and the overall irritation score was 0.0 at any observation time. All untreated eyes were normal throughout the test. Under the study conditions, the test substance was considered not irritating to rabbit eye (Wolf, 2001).
Justification for classification or non-classification
Based on the results of in vivo skin and eye irritation/corrosion studies, the test substance does not meet the criteria for classification for this endpoint according to CLP (Regulation 1272/2008/EC).
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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