Registration Dossier
Registration Dossier
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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
No skin sensitising properties were observed in two available GPMT studies in guinea pigs (Toxicol. Lab. Ltd., Huntingdon, ECHA RSS, 2017).
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This study was conducted due to non-REACH regulatory requirements. With the existing data from this study not only being acceptable but of good quality (Klimisch Score 2), this study precludes the need for an additional LLNA study. In addition, a supplementary LLNA study would violate the ECHA objectives with regards to animal welfare.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
- Route:
- intradermal
- Vehicle:
- coconut oil
- Remarks:
- Alembicol D.
- Concentration / amount:
- 0.05 % w/w
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, open
- Vehicle:
- coconut oil
- Remarks:
- Alembicol D.
- Concentration / amount:
- 50 % w/w
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- coconut oil
- Remarks:
- Alembicol D.
- Concentration / amount:
- 50 % w/w
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, open
- Vehicle:
- coconut oil
- Remarks:
- Alembicol D.
- Concentration / amount:
- 25 % w/w
- No. of animals per dose:
- Test group: 20
Negative control group: 10 - Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was considered to be not sensitising to the skin of guinea pigs.
- Executive summary:
In a dermal sensitisation study according to EU method B.6 (Huntingdon, ECHA RSS, 2017), young adult Dunkin Hartley guinea pigs (20 animals) were tested using the guinea pig maximisation method (GPMT). The test substance was applied in coconut oil (Alembicol D.). Induction was performed via intradermal injection (0.05 % concentration of test substance) or epicutaneously with a test substance concentration of 50 %. Challenge was performed at 25 % and 50 % concentration.
In a separate preliminary study with guinea pigs of the same strain from the same source, the intradermal dose induced a well-defined erythema and slight oedema. The topical dose had no irritant effect.
None of the 10 tested animals showed a positive response in the negative control group. No irritation or skin reactions were observed in any animal of the test group. One of the test animals was found dead prior to exposure. The autopsy showed autolysis of the organs. The cause of the disease could not be observed but was not considered to be treatment-related.
The tests substance is not regarded as skin sensitiser under the above described experimental conditions.
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Referenceopen allclose all
In a separate preliminary study with guinea pigs of the same strain from the same source, the intradermal dose induced a well defined erythema and slight oedema. The topical dose had no irritant effect.
One of the test animals was found dead
prior to exposure. The autopsy showed autolysis of the organs. The cause
of the disease could not be observed but was not considered to be
treatment-related.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- 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.
Key study
In a dermal sensitisation study according to EU method B.6 (Huntingdon, ECHA RSS, 2017), young adult Dunkin Hartley guinea pigs (20 animals) were tested using the guinea pig maximisation method (GPMT). The test substance was applied in coconut oil (Alembicol D.). Induction was performed via intradermal injection (0.05 % concentration of test substance) and epicutaneously with a test substance concentration of 50 %. Challenge was performed at 25 % and 50 % concentration.
In a separate preliminary study with guinea pigs of the same strain from the same source, the intradermal dose induced a well-defined erythema and slight oedema. The topical dose had no irritant effect.
None of the 10 tested animals showed a positive response in the negative control group. No irritation or skin reactions were observed in any animal of the test group. One of the test animals was found dead prior to exposure. The autopsy showed autolysis of the organs. The cause of the disease could not be observed but was not considered to be treatment-related.
The test substance is not regarded as skin sensitiser under the above described experimental conditions.
Supporting study
In a dermal sensitisation study according to EU method B.6 (Toxicol. Lab. Ltd., ECHA RSS, 2017), young adult Dunkin Hartley guinea pigs (20 animals) were tested using the guinea pig maximisation method (GPMT). The test substance was applied in coconut oil (Alembicol D.). Induction was performed via intradermal injection (2 % concentration of test substance) and epicutaneously with a test substance concentration of 60 %. Challenge was performed at 60 % concentration.
In a separate preliminary study with guinea pigs of the same strain from the same source, 60 % was identified as the top dose not causing any irritant effects. The concentration of the test substance used at topical induction (60%) was the maximum attainable in the vehicle chosen.
No irritation or skin reactions were observed in any animal of the test group.
The test substance is not regarded as skin sensitiser under the above described experimental conditions.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
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 skin sensitisation, 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.
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