Registration Dossier
Registration Dossier
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EC number: 227-645-2 | CAS number: 5921-65-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 6-phenyl-1,3,5-triazine-2,4-diyldiamine
- EC Number:
- 202-095-6
- EC Name:
- 6-phenyl-1,3,5-triazine-2,4-diyldiamine
- Cas Number:
- 91-76-9
- IUPAC Name:
- 6-phenyl-1,3,5-triazine-2,4-diamine
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- No additional information available
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source:Harlan Laboratories, NL
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 15-25 g
- Housing: group housing (Makrolon Type III)
- Diet (e.g. ad libitum): pelleted standard diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 °C
- Humidity (%): 45-65 %
- Air changes (per hr): no information available
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 2.5%, 5%, 7.5%
- No. of animals per dose:
- 4
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- Group 1 (control group)
- Key result
- Parameter:
- SI
- Value:
- 1.44
- Test group / Remarks:
- Group 2 (2.5%)
- Key result
- Parameter:
- SI
- Value:
- 1.11
- Test group / Remarks:
- Group 3 (5%)
- Key result
- Parameter:
- SI
- Value:
- 1.09
- Test group / Remarks:
- Group 4 (7.5%)
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Group 1 (control group): 225.6 Group 2 (2.5%): 325.5 Group 3 (5%): 251.0 Group 4 (7.5%): 245.5
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The presented guideline study is reliable and adequate for the chemical safety assessment of 6-phenyl-1,3,5-triazine-2,4-diyldiamine. Based on the findings of the study the test substance is classified as not sensitising.
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