Registration Dossier
Registration Dossier
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EC number: 243-039-0 | CAS number: 19406-86-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000-2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: performed in accordance with OECD and GLP guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 3-amino-p-toluamide
- EC Number:
- 243-039-0
- EC Name:
- 3-amino-p-toluamide
- Cas Number:
- 19406-86-1
- Molecular formula:
- C8H10N2O
- IUPAC Name:
- 3-amino-p-toluamide
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Remarks:
- de-ionized
- Concentration / amount:
- intradermal induction: 5 %
epidermal induction: 25 %
challenge: 25 %
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- de-ionized
- Concentration / amount:
- intradermal induction: 5 %
epidermal induction: 25 %
challenge: 25 %
- No. of animals per dose:
- Treatment: 10
Control: 5 - Details on study design:
- TEST ANIMALS
-strain: HsdPoc:DH
- Source: Harlan Winkelmann, Germany
- Age at study initiation: no data
- Weight at study initiation(main group): 347g to 407g (mean. 379g)
- Housing: 5 animals/cage, Makrolon Type 5, granulated soft wood bedding
- Diet (e.g. ad libitum): ssniffID Ms-H (V2233), ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: yes
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 50 +/-20%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
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 (after challenge (patch removal)): 24 h + 48 h - Positive control substance(s):
- yes
- Remarks:
- 25% alpha-hexyl cinnamic aldehyde in polyethylene glycol 400
Results and discussion
- Positive control results:
- Based on the results of this study (Buehler test) alpha-hexyl cinnamic aldehyde may cause sensitization by skin contact. The test system used in this study proved to be suitable for the determination of dermal sensitizers.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% (0.5ml)
- 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: 25% (0.5ml). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% (0.5ml)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% (0.5ml). 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:
- 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.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- 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: 5.0. Clinical observations: none.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item was found to be not a skin sensitiser in the maximization test.
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