Registration Dossier
Registration Dossier
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EC number: 202-090-9 | CAS number: 91-68-9
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:
- other: scientifically acceptable and valid study, limited documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 957
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Method: Skin Painting test
- GLP compliance:
- no
- Type of study:
- skin painting test
- Justification for non-LLNA method:
- Study was performed before LLNA was formally validated and available as OECD guideline in 2002.
Test material
- Reference substance name:
- 3-diethylaminophenol
- EC Number:
- 202-090-9
- EC Name:
- 3-diethylaminophenol
- Cas Number:
- 91-68-9
- Molecular formula:
- C10H15NO
- IUPAC Name:
- 3-(diethylamino)phenol
- Details on test material:
- - Name of test material (as cited in study report): Diäthyl-m-aminophenol
- Physical state: solid
- Analytical purity: 99 %
- Other: soluble in acetic acid, alcohol, lutrol, ethylenechloride, unsoluble in soda solution and vegetable oil
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 340 - 790 g
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: alcohol
- Concentration / amount:
- - 50 % Induction
- 5% Challenge
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: alcohol
- Concentration / amount:
- - 50 % Induction
- 5% Challenge
- No. of animals per dose:
- - test group: 10 guinea pigs
- control: 2 animals control - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 14 days
- Site: left flank
- Frequency of applications: once daily on 10 consecutive working days
- Duration: 10 x continuously
- Concentrations: 50 % in alcohol
B. CHALLENGE EXPOSURE
- No. of exposures: 1 x
- Day of challenge: day 27
- Exposure period: 24 h
- Test groups: 10 animals
- Control group: 2 animals (no induction)
- Site: right flank
- Concentrations: 5 % in alcohol
- Evaluation (hr after challenge): 24 h - Challenge controls:
- 2 animals treated with 5 % test substance in alcohol at challenge (no induction)
- 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:
- 5 % in alcohol
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5 % in alcohol. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5 % in alcohol
- No. with + reactions:
- 0
- Total no. in group:
- 2
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5 % in alcohol. No with. + reactions: 0.0. Total no. in groups: 2.0.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
