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
Skin sensitisation
Administrative data
- 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
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guideline
- 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.
Test material
- Reference substance name:
- 6'-(dibutylamino)-3'-methyl-2'-(phenylamino)spiro[isobenzofuran-1(3H),9-(9H)-xanthen]-3-one
- EC Number:
- 403-830-5
- EC Name:
- 6'-(dibutylamino)-3'-methyl-2'-(phenylamino)spiro[isobenzofuran-1(3H),9-(9H)-xanthen]-3-one
- Cas Number:
- 89331-94-2
- Molecular formula:
- C35H36N2O3
- IUPAC Name:
- 6'-(dibutylamino)-3'-methyl-2'-(phenylamino)-3H-spiro[2-benzofuran-1,9'-xanthen]-3-one
- Test material form:
- solid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- 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
Challengeopen allclose all
- 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
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- 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
Any other information on results incl. tables
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.
Applicant's summary and conclusion
- 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.
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