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Administrative data

Description of key information

 

A human maximization test was carried out to assess the dermal sensitization potential of the test chemical.

The test chemical 1% in petrolatum did not induce any sensitization reactions on the skin of 30 human volunteers.

Hence, the test chemical was considered to be 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)
Type of information:
experimental study
Adequacy of study:
key study
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:
other: Maximization test
Principles of method if other than guideline:
A human maximization test was carried out to assess the dermal sensitization potential of the test chemical.
GLP compliance:
not specified
Type of study:
other: Maximization test
Justification for non-LLNA method:
Currently no LLNA Study is available for assessment.
Species:
other: humans
Strain:
not specified
Sex:
not specified
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
1% in petrolatum
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
1% in petrolatum
Adequacy of challenge:
not specified
No. of animals per dose:
25
Positive control substance(s):
not specified
Key result
Reading:
1st reading
Group:
test group
Dose level:
1% in petrolatum
No. with + reactions:
0
Total no. in group:
25
Clinical observations:
The test chemical 1% in petrolatum did not induce any sensitization reactions on the skin of 25 human volunteers
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
other: not sensitizing
Conclusions:
The test chemical 1% in petrolatum did not induce any sensitization reactions on the skin of 30 human volunteers.
Hence, the test chemical was considered to be not sensitizing to skin.
Executive summary:

A human maximization test was carried out to assess the dermal sensitization potential of the test chemical. The test chemical 1% 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 1% in petrolatum did not induce any sensitization reactions on the skin of 30 human volunteers.

Hence, the test chemical was considered to be not sensitizing to skin.

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

Various studies have been reviewed to determine the allergic potential of the test chemical in living organisms. These include in vivo experimental studies in humans, guinea pigs as well as estimated data for the test chemical. The results are summarized as follows:

 

A human maximization test was carried out to assess the dermal sensitization potential of the test chemical. The test chemical 1% 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 1% in petrolatum did not induce any sensitization reactions on the skin of 30 human volunteers.

Hence, the test chemical was considered to be not sensitizing to skin.

This is supported by the results of a maximization test performed on male guinea pigs to determine the allergic potential of the test chemical.

Intradermal injections of 0.1 ml of 0.1% suspension (w/v) of the test chemical in a mixture of containing 1 volume of propylene glycol and 29 volume of saline were given in the induction phase to 10 male guinea pigs. After a suitable rest period, ten test guinea pigs received and challenged with 0.1% solution of the test chemical. Ten test guinea pigs were induced and challenged with 0.1% solution of the positive control [DNCB]. Positive control [DNCB] produced a marked sensitization reaction in 10/10 guinea pigs.

Challenge doses of the test chemical(last intradermal injection) did not produce a sensitization effect.

The test chemical did not produce a sensitization reaction under these test conditions and is not expected to cause sensitization reaction to humans.

Hence, the test chemical was considered to be not sensitizing to skin.

Skin sensitization effects were also estimated by three different models i.e, Battery, Leadscope and SciQSAR used within Danish QSAR database for the test chemical

Based on estimation, no skin sensitization reactions were observed in guinea pigs and humans. Therefore, the test chemical was considered to be not sensitizing.

The experimental and estimated results are in agreement with each indicating a very strong possibility the test chemical can be considered to lack the potential to cause dermal sensitization. Hence, the test chemical can be considered to be not sensitizing to skin.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The experimental and estimated results are in agreement with each indicating a very strong possibility the test chemical can be considered to lack the potential to cause dermal sensitization. Hence, the test chemical can be considered to be not sensitizing to skin.