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Description of key information

Various studies have been reviewed to ascertain the degree of dermal sensitization caused by the test chemical in living organisms. These include in vivo experimental studies on humans, guinea pigs for the test chemicals. The results are mentioned below:

A human maximization test was carried out to assess the dermal sensitization potential of the test chemical. The test chemical 8% in petrolatum was applied to the skin of 24 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 24human 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: Human 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: Human Maximization test
Justification for non-LLNA method:
Currently no LLNA study is available for assessment. The Guinea Pig Maximization Test (GPMT) 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
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
8% in petrolatum
Day(s)/duration:
no data available
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
8% in petrolatum
Adequacy of challenge:
not specified
No. of animals per dose:
24 hours
Details on study design:
No data available
Challenge controls:
No data available
Positive control substance(s):
not specified
Key result
Reading:
1st reading
Group:
test group
Dose level:
8% in petrolatum
No. with + reactions:
0
Total no. in group:
24
Clinical observations:
no signs of dermal reactions observed
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
other: not sensitizing
Conclusions:
The test chemical 8% in petrolatum did not induce any sensitization reactions on the skin of 24 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 8% in petrolatum was applied to the skin of 24 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 24human 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 ascertain the degree of dermal sensitization caused by the test chemical in living organisms. These include in vivo experimental studies on humans, guinea pigs for the test chemicals. The results are mentioned below:

A human maximization test was carried out to assess the dermal sensitization potential of the test chemical. The test chemical 8% in petrolatum was applied to the skin of 24 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 24human volunteers.

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

Skin sensitization effects were also estimated by four different models i.e, Battery, Leadscope, SciQSAR and CASE Ultra 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.

These results are supported by an Open Epicutaneous Test (OET) performed on guinea pigs to assess the skin sensitization potential of test chemical.

On day 1 during induction, 0.1 ml of the test chemical was applied at concentrations of 100%, 30%, 10%, 3%, 1%, or 0.3% in vehicle to an area measuring 8 cm2 on the clipped flank skin of the guinea pigs. The applications are repeated daily for 3 weeks or done 5 times weekly during 4 weeks, usually on the same skin sites. The application sites were left uncovered and the reactions, if continuous daily applications were performed, can be read 24 h after each application, or at the end of each week.

To determine whether or not contact sensitization was induced, all groups of guinea pigs previously treated for 21 days, as well as 10 untreated, or only pretreated with the vehicle, controls are tested on days 21 and 35 on the contralateral flank with the test material. This test was performed by applying with a pipette 0.025 ml of each concentration to skin areas measuring 2 cm2. The reactions were read after 24,48 and/or 72h.

It was observed that none of the guinea pigs induced contact sensitization at challenge concentration of 2%.Thus the test chemical was considered to be not sensitizing on skin of guinea pigs at concentration of 2% in an Open Epicutaneous Test (OET).

The above results are further supported by a maximization test carried out with 4% (2760 microgram/cm2) test chemical in petrolatum on 25 healthy male patients. Application was under occlusion to the same site on the forearms of all subjects for five alternate day, 48 h periods. The patch sites were pretreated for 24 hours 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 hour with 10% SLS. The challenge site was evaluated at 48 and 72 hours. No sensitization reactions were observed after the challenge exposure. Hence, the test chemical was considered to be not sensitizing to skin.

 

Available results for the test chemical indicate a possibility that the test chemical is not likely to cause any dermal reactions to the skin. 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

Available results for the test chemical indicate a possibility that the test chemical is not likely to cause any dermal reactions to the skin. Hence, the test chemical can be considered to be not sensitizing to skin.