Registration Dossier

Administrative data

Description of key information

SPE1415 gave a negative result in a reliable LLNA. This finding is consistent with the negative result from a reliable GPMT on the structural analogue ATMP (acid). Additional supporting data on another confidential analogue substance is discussed in Additional 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:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Qualifier:
according to
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
other: CBA/Ca (CBA/CaOlaHsd)
Sex:
female
Vehicle:
other: Water
Concentration:
5, 10 and 25% w/w
No. of animals per dose:
4
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Positive control results:
A recent study using a positive control substance gave a positive result (SI = 8.16)
Parameter:
SI
Remarks on result:
other: 5% = 1.12 10% = 1.23 25% = 1.20
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: 5% = 9854.31 10% = 10831.87 25% = 10553.27
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance gave a negative ie non-sensitising result in the LLNA.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The substance and its structural analogues consistently demonstrated negative results in reliable in vivo sensitisation assays. Therefore there is no justification for classification of the substance.