Registration Dossier
Registration Dossier
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EC number: 406-040-9 | CAS number: 125643-61-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not specified
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP (taken from SNIF file). Registrant referring to studies >12 years old at the permission of ECHA.
Data source
Reference
- Reference Type:
- other: body responsible for the test.
- Title:
- Unnamed
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 84/449/EWG, B.6 , OECD 406 (1981) (guinea pig maximization test (GPMT))
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- -
- EC Number:
- 406-040-9
- EC Name:
- -
- Cas Number:
- 125643-61-0
- Molecular formula:
- C17 H25 O3 R, Where R = (C7 H15) or (C8 H17) or (C9 H19)
- IUPAC Name:
- Reaction mass of C7-9-alkyl 3-(3,5-di-trans-butyl-4-hydroxyphenyl)propionate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright Tif:DHP
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Vaseline
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) intradermale lnduction: 1 % in Sesamol
b) epidennale lnduction: 30% in Vaseline
Concentration of test material and vehicle used for each challenge:
a) 10 % in Vaseline
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: Vaseline
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) intradermale lnduction: 1 % in Sesamol
b) epidennale lnduction: 30% in Vaseline
Concentration of test material and vehicle used for each challenge:
a) 10 % in Vaseline
- No. of animals per dose:
- Number of animals In test group: 20
Number of animals in negative control group: 10 - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% in Vaseline
- 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: 10% in Vaseline. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% in Vaseline
- 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: 10% in Vaseline. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
In vivo (LLNA)
Results
- Parameter:
- SI
- Remarks on result:
- other: Determined by means of preliminary tests: erythema occurred at 30% in vaseline, 10% was the highest non-irritant concentration. Consequently, the epidermal induction was performed with 30% and the challenge with 10% substance in vaseline.
Any other information on results incl. tables
Determined by means of preliminary tests: erythema occurred at 30% in vaseline, 10% was the highest non-irritant concentration. Consequently, the epidermal induction was performed with 30% and the challenge with 10% substance in vaseline.
No signs of irritation where noted at induction. No signs of sensitisation where noted at challenge.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No signs of irritation where noted at induction. No signs of sensitisation where noted at challenge.
- Executive summary:
No signs of irritation where noted at induction. No signs of sensitisation where noted at challenge.
No classification is applicable.
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