N,N',N'',N'''-tetrakis(4,6-bis(butyl-(N-methyl-2,2,6,6-tetramethylpiperidin-4-yl)amino)triazin-2-yl)-4,7-diazadecane-1,10-diamine

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

EU Method B.6 (Skin Sensitisation)

GLP compliance:

yes

Type of study:

guinea pig maximisation test

Species:

guinea pig

Strain:

Pirbright-Hartley

Sex:

not specified

Concentration / amount:

Concentration of test material and vehicle used at induction:
First induction (intradermal injection): 1% in sesame oil and adjuvant saline mixture.

Second induction (epidermal application): 10% in vaseline

Concentration of test material and vehicle used for each challenge: 0.3 % in vaseline

Concentration / amount:

Concentration of test material and vehicle used at induction:
First induction (intradermal injection): 1% in sesame oil and adjuvant saline mixture.

Second induction (epidermal application): 10% in vaseline

Concentration of test material and vehicle used for each challenge: 0.3 % in vaseline

No. of animals per dose:

Number of animals in test group: 20
Number of animals in negative control group: 10

Reading:

other: each challenge

Group:

test chemical

Total no. in group:

20

Clinical observations:

Evidence of sensitisation of each challenge concentration: 60- 75% of the animals were sensitized under the experimental conditions employed.

Remarks on result:

other: Reading: other: each challenge. Group: test group. Total no. in groups: 20.0. Clinical observations: Evidence of sensitisation of each challenge concentration: 60- 75% of the animals were sensitized under the experimental conditions employed..

At one hour a score of one was seen in one animal. No inflammation was observed between 24 and 72 hours.

Interpretation of results:

sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance is classified as a skin sensitizer.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

Evidence of sensitisation of each challenge concentration: 60- 75% of the animals were sensitized under the experimental conditions employed.

The test substance required the classification as sensitiser.

It is classified in the Annex VI of Regulation no.1272/2008 with the reference number 613-078-00-1.

Migrated from Short description of key information:
The sensitisation potential was investigated following the EU Method B.6, performed more than 12 years ago, under GLP conditions.

Justification for selection of skin sensitisation endpoint:
Only one study available

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

Justification for selection of respiratory sensitisation endpoint:
Endpoint not requested for the registered tonnage band .

Justification for classification or non-classification

Since 60- 75% of the animals showed evidence of sensitisation of each challenge concentration, under the experimental conditions

employed, the test substance need to be classified as skin sensitiser.