Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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:
other: The study was performed according to OECD guideline study with GLP compliance.
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)
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

Vehicle:
dimethyl sulphoxide
Concentration:
2.5%, 5%, 7.5%
No. of animals per dose:
4
Parameter:
SI
Remarks on result:
other: Group 1 (control group): 1.00 Group 2 (2.5%): 1.44 Group 3 (5%): 1.11 Group 4 (7.5%): 1.09
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
Interpretation of results:
not sensitising
Remarks:
Migrated information
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Migrated from Short description of key information:
Negative result in LLNA (OECD 429) study.

Justification for selection of skin sensitisation endpoint:
The study was performed according to OECD guideline study with Klimisch score 1.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

The presented substance has no indication for skin sensitisation and is therefore not a respiratory sensitiser either (REACH technical guidance document: scheme of R7A, Fig 7.3-2).

The uptake after direct inhalation of the substance may be of low relevance due to the high mean diameter of particles, which significantly exceeds the maximum inhalable particle diameter of 100 µm. Uptake by inhalation after evaporation is unlikely, the substance is solid at room temperature and has a very high boiling point together with a very low vapour pressure.


Migrated from Short description of key information:
Not respiratory sensitising

Justification for classification or non-classification

The findings in the presented OECD 429 guideline study are conclusive but not sufficient for a classification according Regulation (EC) No. 1272/2008.