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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

A maximization test was carried out on 29 human volunteers to assess the dermal sensitization potential of test chemical. The test chemical was applied to the skin of human volunteers at a dose of 2% in petrolatum and observed for effects (duration not specified). The chemical neither caused any dermal reactions nor dermal sensitizing effects. Hence, the test chemical can be considered as not sensitizing to skin.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
data is from peer reviewed journals
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To assess the dermal sensitization potential of test chemical in humans.
GLP compliance:
not specified
Type of study:
other: Human Maximization test
Justification for non-LLNA method:
Currently no LLNA study is available for assessment. The Human Maximization test has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.
Species:
other: humans
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
2% in petrolatum
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
2% in petrolatum
Adequacy of challenge:
not specified
No. of animals per dose:
29 human volunteers
Details on study design:
No data
Challenge controls:
No data
Positive control substance(s):
not specified
Positive control results:
No data
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
2% in petrolatum
No. with + reactions:
0
Total no. in group:
29
Clinical observations:
no reactions observed
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
other: not sensitizing
Conclusions:
The test chemical did not cause any dermal reactions and no dermal sensitizing effects were observed.Hence, the test chemical can be considered to be not sensitizing to skin.
Executive summary:

A maximization test was carried out on 29 human volunteers to assess the dermal sensitization potential of test chemical.The test chemical was applied to the skin of human volunteers at a dose of 2% in petrolatum and observed for effects (duration not specified). The chemical neither caused any dermal reactions nor dermal sensitizing effects. Hence, the test chemical can be considered as not sensitizing to skin.

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

Various studies have been reviewed to determine the sensitization potential of the test chemical in living organisms. These include in vivo experimental studies performed on humans for the test chemical.

A maximization test was carried out on 29 human volunteers to assess the dermal sensitization potential of test chemical. The test chemical was applied to the skin of human volunteers at a dose of 2% in petrolatum and observed for effects (duration not specified). The chemical neither caused any dermal reactions nor dermal sensitizing effects. Hence, the test chemical can be considered as not sensitizing to skin.

This is supported by another maximization test carried out to assess the sensitization potential of the test chemical in humans 4% test chemical [2760 µg/cm2] in petrolatum was applied under occlusion to the same site on the forearms of 25 healthy male volunteers for five alternate days, 48 hours periods. The patch sites were pre-treated for 24 h with 5% aqueous sodium lauryl sulfate (SLS) under occlusion. Following a 10 day rest period, challenge patches were applied to fresh sites on the back for 48 h under occlusion. The challenge site was pre-treated for 1 h with 10% SLS. The challenge site was evaluated at 48 and 72 hours. On evaluation of the challenge site at 48 and 72 hours, no sensitization reactions were observed. Hence, the test chemical was considered to be non-sensitizing to skin in humans.

The above maximization test results are further supported by a similar human maximization test carried out to assess the dermal sensitization potential of the test chemical. The test chemical 8% in petrolatum was applied to the skin of 25 human volunteers and observed for signs of dermal sensitization (duration of exposure, observation period not specified). The test chemical 8% in petrolatum did not induce any sensitization reactions on the skin of 25 human volunteers. Hence, the test chemical was considered to be not sensitizing to skin.

Based on the available studies and applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin. It can be further classified under the category “Not Classified” as per CLP Regulation.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available studies and applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin. It can be further classified under the category “Not Classified” as per CLP Regulation.