Registration Dossier
Registration Dossier
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EC number: 696-038-6 | CAS number: 135452-43-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test was conducted according to EU Method B.6 and compliant with GLP. Read-across from supporting substance (structure analogue or surrogate). Test substance (source substance): EC No. 402-990-3
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 989
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
Test material
- Reference substance name:
- Reaction mass mainly based on 2,3-dihydro-6-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene and 2,3-dihydro-5-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene
- IUPAC Name:
- Reaction mass mainly based on 2,3-dihydro-6-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene and 2,3-dihydro-5-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene
- Reference substance name:
- A mixture mainly based on: 2,3-dihydro-6-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene; 2,3-dihydro-5-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene
- EC Number:
- 402-990-3
- EC Name:
- A mixture mainly based on: 2,3-dihydro-6-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene; 2,3-dihydro-5-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene
- IUPAC Name:
- 402-990-3
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: albino guinea pigs
Study design: in vivo (non-LLNA)
Induction
- Concentration / amount:
- Concentration of test material and vehicle used at induction: intradermal - 0.1% test article in liquid paraffin in 0.1 ml of preparation and 0.2% of test article in preparation.
Cutaneous - 0.5 ml of test article in form of paste 60% w/w in steril liquid paraffin (occlusive topical route)
Concentration of test material and vehicle used for each challenge: 0.5 ml of test article in form of paste 60% w/w in steril liquid paraffin (occlusive topical route)
Challenge
- Concentration / amount:
- Concentration of test material and vehicle used at induction: intradermal - 0.1% test article in liquid paraffin in 0.1 ml of preparation and 0.2% of test article in preparation.
Cutaneous - 0.5 ml of test article in form of paste 60% w/w in steril liquid paraffin (occlusive topical route)
Concentration of test material and vehicle used for each challenge: 0.5 ml of test article in form of paste 60% w/w in steril liquid paraffin (occlusive topical route)
- No. of animals per dose:
- In test group: 20
In negative control group: 20
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Any other information on results incl. tables
Signs of irritation duiring induction:
Injection provoked a weak to moderate irritation during the preliminary study. Topical occlusive route provoked a weak to moderate irritation due probably by tearing.
Evidence of sensitisation of each challenge concentration: None
Other observations:
Positive control group with positive effect due to DNCB.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is not a skin sensitiser under the test conditions of the this study.
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