Registration Dossier
Registration Dossier
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EC number: 207-821-5 | CAS number: 496-46-8
Endpoint summary
Administrative data
Description of key information
Skin irritation:
An in vivo study was conducted, according to OECD TG 404 (1999), to assess the acute dermal irritation or corrosion potential of the test substance. The study was conducted on three rabbits (New Zealand White). 0.5g of test substance was applied by a single topical application to the intact skin of the animal, for 4 hours under semi-occlusive dressing. The average score (24 -72 hours) for irritation was calculated to be 0.4 for erythema and 0.0 for oedema. The skin findings were reversible in all animals within 72 hours after the removal of the patches; as such the study was terminated after this period. Under the test conditions and the findings, it can be concluded that the test substance does not cause irritating properties to the skin and therefore is unclassified under Regulation 1272/2008.
Eye irritation:
An in vivo eye irritation test was carried out, according to OECD TG 405 (1999), to assess the eye irritation potential of the test substance. The study was conducted on three rabbits (New Zealand White). The test substance was applied to one eye in a single ocular application of 0.1mL bulk volume (~46mg) while the other was used as a negative control for each rabbit. The rabbits were observed for any sign of eye irritation. The average score (24 -72 hours) for irritation was calculated to be 0.0 for corneal opacity, iris, and chemosis whilst 0.2 for conjunctival redness. These clinical observations were reversible in all animals within 48 hours after the application of the test substance; as such the study was terminated after 72 hours. Under the test conditions and the findings, it can be concluded that the test substance does not cause irritating properties to the eye and therefore is unclassified under Regulation 1272/2008.
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:
- 1999
- 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
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Batch number: Zwischenprodukt aus Partie 692.
Date of manufacturing: 27 July 1998. - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Test animals
Source: Boehringer Ingelheim Pharma KG.
Age: Young Adults.
Housing: Single Housing.
Diet: Kliba-Labordiaet, Klingentalmuehle AG Kaiseraugst, Switzerland (about 130g/animal/day)
Water: Tap water, ~250mL/day.
Acclimatisation Period: At least 1 week.
Environmental Conditions
Temperature (C): 20 - 24.
Humidity (%): 30-70.
Air changes (per hour): Not Reported.
Photoperiod (hrs dark/hrs light): 12/12. - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The test substance was moistened with aqua bidest (because of the natural moisture of the skin, distilled water was used so that the test has been carried out under as physilogical conditions as possible).
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- Amount applied was 0.5g of the unchanged solid test substance in a single dose to the intact untreated skin. Application site was the upper third of the back or flanks of the animals.
- Duration of treatment / exposure:
- Duration: 4 hours.
Date of application: 05 October 1998. - Observation period:
- 72 Hours
- Number of animals:
- 3 (1 male, 2 females)
- Details on study design:
- At least 24 hours before the test, the fur was removed via clipping of the dorsal part of the trunk of each of the animals, those with healthy intact skin have been used.
The test substance was applied in a single dose and the test patch was secured in position with a semiocclusive dressing (test patch: Idealbinde, Pfaelzische Verbandstoff-Fabrik, Kaiserslautern; adhesive fleece: Fixomull(R) stretch, Beiersdorf AG). The test substance was then removed at the end of the exposure period with Lutrol (r) and Lutrol(R)/water (1:1) (Lutrol(R) E 400 = Polyethylenglycol DAB, BASF Aktiengesellschaft). - Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 0.7
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is non-irritating to the skin.
- Executive summary:
An in vivo study was conducted, according to OECD TG 404 (1999), to assess the acute dermal irritation or corrosion potential of the test substance. The study was conducted on three rabbits (New Zealand White). 0.5g of test substance was applied by a single topical application to the intact skin of the animal, for 4 hours under semi-occlusive dressing. The average score (24 -72 hours) for irritation was calculated to be 0.4 for erythema and 0.0 for oedema. The skin findings were reversible in all animals within 72 hours after the removal of the patches; as such the study was terminated after this period. Under the test conditions and the findings, it can be concluded that the test substance does not cause irritating properties to the skin and therefore is unclassified under Regulation 1272/2008.
- Endpoint:
- skin corrosion: 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:
- In accordance with REACH Regulation (EC) No. 1907/2006 Annex VII, column 2 section 8.1.1 (as amended by Commission Regulation (EU) 2016/863) the in vitro skin corrosion (OECD TG 431) study does not need to be conducted based on the available information allowing a definitive conclusion on the classification of the substance. An available in vivo (OECD TG 404) skin irritation study is available and data in other endpoints (such as skin sensitisation and/or acute dermal toxicity) indicates that the substance is not skin corrosive and a definitive conclusion on the classification can be made. Furthermore, in accordance with section 1.2 of REACH Regulation (EC) No. 1907/2006 Annex XI the weight of evidence indicates that the substance is not skin corrosive and therefore in vitro testing may be omitted. According to ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.2, July 2017) the study does not need to be conducted.
Referenceopen allclose all
Exposure Period 4 hours |
|||
| Reading | Animal | Erythema | Edema |
| 1 hr | 1 | 1 | 0 |
| 2 | 1 | 0 | |
| 3 | 0 | 0 | |
| 24 hrs | 1 | 1 | 0 |
| 2 | 0 | 0 | |
| 3 | 1 | 0 | |
| 48 hrs | 1 | 1 | 0 |
| 2 | 0 | 0 | |
| 3 | 1 | 0 | |
| 72 hrs | 1 | 0 | 0 |
| 2 | 0 | 0 | |
| 3 | 0 | 0 | |
| Mean | 1 | 0.7 | 0 |
| 2 | 0 | 0 | |
| 3 | 0.7 | 0 | |
| Mean | 0.4 | 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
- Study period:
- 1999
- 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:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Batch number: Zwischenprodukt aus Partie 692.
Date of manufacturing: 27July 1998. - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Test Animals
Source: Boehringer Ingelheim Pharma KG.
Age: Young Adults.
Housing: Single Housing.
Diet: Kliba-Labordiaet, Klingentalmuehle AG Kaiseraugst, Switzerland (about 130g/day).
Water: Tap water, ~250mL/day.
Acclimatisation period: at least 1 week.
Environmental Conditions
Temperature (C): 20 - 24.
Humidity (%): 30-70.
Air changes (per hour): Not Reported.
Photoperiod (hrs dark/hrs light): 12/12. - Vehicle:
- not specified
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- Amount was 0.1mL bulk volume (about 46mg of the comminuted test substance).
Date of application: Animal 1: 05 October 1998; Animals 2 & 3: 12 October 1998. - Duration of treatment / exposure:
- 24 hours.
- Observation period (in vivo):
- 72 hours.
- Number of animals or in vitro replicates:
- 3 (females).
- Details on study design:
- Both eyes of the animals were assessed for abnormalities which would confound the study prior to application of test material.
The test substance was applied in a single dose to the conjunctival sac of the right eyelid; the test substance was washed out about 24 hours after application (before 24 hours reading). - Irritation parameter:
- conjunctivae score
- Remarks:
- Redness.
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 0.3
- Reversibility:
- fully reversible within:
- Remarks:
- 48 hours after application.
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 48 hours after application.
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 48 hours after application.
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 48 hours after application.
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness.
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 48 hours after application.
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 48 hours after application.
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 48 hours after application.
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 48 hours after application.
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness.
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 0.3
- Reversibility:
- fully reversible within: 48 hours after application.
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 48 hours after application.
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 48 hours after application.
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 48 hours after application.
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is a non-irritant to the eye.
- Executive summary:
An in vivo eye irritation test was carried out, according to OECD TG 405 (1999), to assess the eye irritation potential of the test substance. The study was conducted on three rabbits (New Zealand White). The test substance was applied to one eye in a single ocular application of 0.1mL bulk volume (~46mg) while the other was used as a negative control for each rabbit. The rabbits were observed for any sign of eye irritation. The average score (24 -72 hours) for irritation was calculated to be 0.0 for corneal opacity, iris, and chemosis whilst 0.2 for conjunctival redness. These clinical observations were reversible in all animals within 48 hours after the application of the test substance; as such the study was terminated after 72 hours. Under the test conditions and the findings, it can be concluded that the test substance does not cause irritating properties to the eye and therefore is unclassified under Regulation 1272/2008.
- 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:
- In accordance with REACH Regulation (EC) No. 1907/2006 Annex VII, column 2 section 8.1.2 (as amended by Commission Regulation (EU) 2016/863) the serious eye damage / eye irritation (OECD TG 437 or OECD TG 438) study does not need to be conducted based on the available information allowing a definitive conclusion on the classification of the substance. An available in vivo (OECD TG 405) eye irritation study is available that indicates that the substance is not eye irritating and a definitive conclusion on the classification can be made. According to ECHA Guidance on Information Requirements and Chemical Safety Assessment (Chapter R.7a: Endpoint Specific Guidance, R.7.2, July 2017) the study does not need to be conducted.
Referenceopen allclose all
24 hour exposure |
|||||||
| Reading | Animal | Cornea (opacity) | Cornea (area) | Iris | Conjunctiva (redness) | Conjuctiva (swelling) | Conjuctiva (discharge) |
| 1 hr | 1 | 0 | 0 | 0 | 2 | 1 | 1 |
| 2 | 0 | 0 | 0 | 1 | 0 | 0 | |
| 3 | 0 | 0 | 0 | 2 | 1 | 0 | |
| 24 hrs | 1 | 0 | 0 | 0 |
1 | 0 | 0 |
| 2 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 3 | 0 | 0 | 0 | 1 | 0 | 0 | |
| 48 hrs | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 3 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 72 hrs | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 3 | 0 | 0 | 0 | 0 | 0 | 0 | |
| Mean | 1 | 0 | 0 | 0.3 | 0 | ||
| 2 | 0 | 0 | 0 | 0 | |||
| 3 | 0 | 0 | 0.3 | 0 | |||
| Mean | 0 | 0 | 0.2 | 0 | |||
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
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.
