Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 403-830-5 | CAS number: 89331-94-2 B 290; BK 400; CK 34; DIBUTYL-N-102; DX-20; FAT NR. 40391/A; FLUORAN BLACK BD 869; FLUORAN SCHWARZ BD 869; NOIR FLUORANE BD 869; ODB-2; PSD-290; SENOR-2; TG-31; TH-108; WINCON-2
Endpoint summary
Administrative data
Description of key information
Skin:
In a skin irritation assay according to EU method B.4 in rabbit (Huntingdon, ECHA RSS, 2017), no skin irritating properties were determined.
Eye:
In an eye irritation assay according to EU method B.5 in rabbit (Huntingdon, ECHA RSS, 2017), no eye irritating properties were determined.
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:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- as cited in 84/449/EEC
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 500 mg - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- 500 mg test substance was moistened with 0.5 mL of distilled water and was covered with a 6.25 cm² gauze pad.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of skin irritation were observed at any time during the study.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance did not show any dermal irritation after a single semi occlusive application to the intact rabbit skin for 24 hours.
- Executive summary:
In a primary dermal irritation study according to EU method B.4 (Huntingdon, ECHA RSS, 2017), young adult New Zealand White rabbits were dermally exposed to 0.5 mg of the unchanged test substance under a semi occlusive dressing for 24 hours. Animals were then observed for 72 hours. Irritation was scored by the method of Draize et al. (1960). No signs of skin irritation were observed at any time during the study. In this study, the test substance is not a dermal irritant.
- 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 vivo study was performed before 1 June 2008 for the registration of WinCon-2 under the old chemical legislation. This data is no longer protected and therefore it was retrieved from ECHA in 2017 as an Article 25(3) request.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Adjacent eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL (equivalent to 40 mg) - Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: According to Draize et al. (1960)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- 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:
- 4
- 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:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- In all three animals a very slight conjunctival irritation was observed after 1 h. This effect was fully reversible within 24 h.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was considered to be not irritating to the eye of New Zealand White rabbits in a eye irritation test according to EU Method B.5.
- Executive summary:
In a primary eye irritation study according to EU method B.5 (Huntingdon, ECHA RSS, 2017), 0.1 mL (equivalent to 40 mg) of the test substance was instilled into the conjunctival sac of the eye of three young adult New Zealand White rabbits. Animals were then observed for 72 hours. Irritation was scored by the method of Draize et al. (1960).
Very slight conjunctival irritation was observed at one hour after treatment, but had resolved by the end of the first day. No other eye effects were noticeable at the end of the observation period. In this study the test substance is not regarded as eye irritant.
- 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 vivo study was performed before 1 June 2008 for the registration of WinCon-2 under the old chemical legislation. This data is no longer protected and therefore it was retrieved from ECHA in 2017 as an Article 25(3) request.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In accordance with Article 25(3) of the REACH Regulation the robust study summaries submitted 12 years previously, are used for the purpose of the registration.
Skin irritation
Key study
In a primary dermal irritation study according to EU method B.4 (Huntingdon, ECHA RSS, 2017), young adult New Zealand White rabbits (3 animals) were dermally exposed to 0.5 mg of the unchanged test substance under a semi-occlusive dressing for 24 hours. Animals were then observed for 72 hours. Irritation was scored by the method of Draize et al. (1960). No signs of skin irritation were observed at any time during the study. In this study, the test substance did not show skin irritating properties.
Supporting study
In a primary dermal irritation study according to EU method B.4 (Pharmaco-LSR, ECHA RSS, 2017), young adult New Zealand White rabbits were dermally exposed to 0.5 mg of the unchanged test substance under a semi occlusive dressing for 4 hours. Animals were then observed for 72 hours. Irritation was scored by the method of Draize et al. (1960). No signs of skin irritation were observed at any time during the study. In this study, the test substance did not show skin irritating properties
Eye irritation
Key study
In an eye irritation assay according to EU method B.5 in rabbit (New Zealand White) (Huntingdon, ECHA RSS, 2017), the eye irritating properties of the test substance were determined. The test substance was tested on three animals. Iris and cornea opacity score were 0.0 (no signs of irritation). In all three animals a very slight conjunctival irritation was observed after 1 h. This effect was fully reversible within 24 h. Accordingly, the test substance was considered to be not irritating to the eye.
Supporting study
In a primary eye irritation study according to EU method B.5 (Pharmaco-LSR, ECHA RSS, 2017), 100 mg of the test substance was instilled into the conjunctival sac of one eye of three young adult New Zealand White rabbits. Animals were then observed for 8 days. Irritation was scored by the method of Draize et al. (1960).
Animal No 1 showed slight conjunctivae redness as well as diffuse areas of opacity. Furthermore slight effects on the iris and some swelling of the eye above the normal were observed. In addition to the effects scored, 2 animals showed slight conjunctival discharge during the first 24 hours post administration. There were no effects noticeable by study day 8. Thus, the test substance is not regarded as eye irritant.
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on eye and skin irritation/corrosion, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.
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.
