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Toxicological information

Skin sensitisation

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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:
other: The study was performed according to OECD guideline study with GLP compliance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010

Materials and methods

Test guideline
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)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
solid

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
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

Applicant's summary and conclusion

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.