Registration Dossier
Registration Dossier
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EC number: 202-185-5 | CAS number: 92-74-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Full report available, GLP-compliant, Standard method
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Naphtol AS-PH
- IUPAC Name:
- Naphtol AS-PH
- Reference substance name:
- 2'-ethoxy-3-hydroxy-2-naphthanilide
- EC Number:
- 202-185-5
- EC Name:
- 2'-ethoxy-3-hydroxy-2-naphthanilide
- Cas Number:
- 92-74-0
- Molecular formula:
- C19H17NO3
- IUPAC Name:
- N-(2-ethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White
- Sex:
- female
- Details on test animals and environmental conditions:
Light: 12 h
Temperature: 22 C
Humidity: 55 %
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- paraffin oil
- Concentration / amount:
- intradermal induction: 0,2 %
epidermal induction: 25 %
challenge: 25 %
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- intradermal induction: 0,2 %
epidermal induction: 25 %
challenge: 25 %
- No. of animals per dose:
- Treatment: 10
Control: 5 - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Test groups: 1
- Control group: 1
- Site: back
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: 24 h
- Test groups: 1
- Control group: 1
- Site: Back
- Concentrations: 25 %
- Evaluation (hr after challenge): 24 h - 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:
- 25 % ( 500 mg)
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- sligt to moderate erythema and edema, dry skin, eschar
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 % ( 500 mg). No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: sligt to moderate erythema and edema, dry skin, eschar.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- 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: 5.0. Clinical observations: none.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- Classification: sensitizing
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