Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

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:
other: GLP compliance, not OECD guideline

Data source

Reference
Reference Type:
other: inquiry result from ECHA
Title:
Unnamed
Year:
2014

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex V (Maximisation test)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
400-820-2
EC Name:
-
Cas Number:
84268-33-7
Molecular formula:
C20H23N3O3
IUPAC Name:
methyl 3-[3-(2H-1,2,3-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl]propanoate

In vivo test system

Test animals

Species:
other: Guinea-pig

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration of test material and vehicle used at induction:
Intradermal: 1% in sesame oil and in adjuvant mixture
Epidermal: 20% in vaseline
Concentration of test material and vehicle used for each challenge:
10% in vaseline
Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:
Intradermal: 1% in sesame oil and in adjuvant mixture
Epidermal: 20% in vaseline
Concentration of test material and vehicle used for each challenge:
10% in vaseline
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 10

Results and discussion

Positive control results:
LLNA

Any other information on results incl. tables

Signs of irritation during induction:

None

Evidence of sensitisation of each challenge concentration:Signs of irritation during induction:

None

Applicant's summary and conclusion

Interpretation of results:
other: not classified