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Administrative data

Description of key information

Supporting study. Test method similar to OECD guideline 406. The substance was no sensitizing.

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:
supporting study
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
(A scientific review (peer reviewed). No data on GLP)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
A human maximization study was carried out with 5% (3450 µg/cm2) fenchyl acetate in petrolatum on 25 (10 male:15 female) healthy volunteers. The author of the study report is Dr. Klingman - coauthor of the maximization test adopted by OECD.
GLP compliance:
not specified
Type of study:
other: Human maximization test
Species:
human
Sex:
not specified
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
5 % (3450 µg/cm2)
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
5 % (3450 µg/cm2)
No. of animals per dose:
25 (10 male:15 female) healthy volunteers.
Details on study design:
Application was under occlusion to the same site on the forearms of all subjects for five alternate-day 48-hour periods. Patch sites were pretreated for 24 h with 5% aqueous sodium lauryl sulfate (SLS) under occlusion. Following a 10 day rest period, challenge patches were applied under occlusion to fresh sites for 48 h. Challenge applications were preceded by 1-hour applications of 10% aqueous SLS under occlusion. Challenge sites were read on removal of the patch and 24 h thereafter.
Reading:
1st reading
Hours after challenge:
0
Group:
test chemical
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
24
Group:
test chemical
Remarks on result:
no indication of skin sensitisation

No sensitization reactions (0/25) were observed.

Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
The substance was no sensitizing.
Executive summary:

A human maximization (Kligman, 1966) study was carried out with 5% (3450 µg/cm2) fenchyl acetate in petrolatum on 25 (10 male:15 female) healthy volunteers. Application was under occlusion to the same site on the forearms of all subjects for five alternate-day 48-hour periods. Patch sites were pretreated for 24 h with 5% aqueous sodium lauryl sulfate (SLS) under occlusion. Following a 10 day rest period, challenge patches were applied under occlusion to fresh sites for 48 h. Challenge applications were preceded by 1-hour applications of 10% aqueous SLS under occlusion. Challenge sites were read on removal of the patch and 24 h thereafter. No sensitization reactions (0/25) were observed.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Supporting study. A human maximization (Kligman, 1966) study was carried out with 5% (3450 µg/cm2) fenchyl acetate in petrolatum on 25 (10 male:15 female) healthy volunteers. Application was under occlusion to the same site on the forearms of all subjects for five alternate-day 48-hour periods. Patch sites were pretreated for 24 h with 5% aqueous sodium lauryl sulfate (SLS) under occlusion. Following a 10 day rest period, challenge patches were applied under occlusion to fresh sites for 48 h. Challenge applications were preceded by 1-hour applications of 10% aqueous SLS under occlusion. Challenge sites were read on removal of the patch and 24 h thereafter. No sensitization reactions (0/25) were observed.

Justification for classification or non-classification

One of the impurities of this multiconstituent substance, dipentene, is included in Table 3 of Annex VI of CLP Regulation (harmonised classification and labelling) and it is classified as:

Skin Sensitizer Category 1, H317.

Taking into account that the concentration of this impurity is higher than 1%, the substance is classified as:

Skin Sensitizer Category 1, H317.

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