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Toxicological information

Skin sensitisation

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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:
1989

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

Constituent 1
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
Constituent 2
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

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.