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Description of key information

The skin sensitization potential of test chemical was assessed in various experimental studies conducted on human subjects. Based on the available data for the test chemical and supporting studies, it can be concluded that the test chemical is unable to cause skin sensitization and thus can be considered as not sensitizing. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “non-Skin Sensitizer”.

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
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 chemical
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.

In another study,the test chemical is added to 1% aqueous cream and hydrous ointment as a preservative. A standard patch testing series was performed with the ingredients of aqueous cream in 2736 patients to identify potential skin sensitizers present in the formulation. 1% test chemical in petrolatum failed to induce any signs of irritation or sensitization at 2 or 4 days after application. Hence the test chemical can be considered to be not sensitizing to human skin.

The above results are further supported by a human repeated insult patch test (HRIPT) which was conducted on 39 volunteers to assess the contact sensitization potential of test chemical.Each subject was induced with 1.2% of test chemical in EtOH three times per week for 3 weeks under occlusive condition. After induction, all the treated subjects were challenged at same concentration used in induction and later observed for skin reactions after 24 hours. None of the volunteers showed any signs of skin sensitization. Hence the test chemical was considered to be not sensitizing to the skin of human subjects.

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

The skin sensitization potential of test substance was observed in various studies. The results obtained from these studies concluded that the chemical is not likely to cause skin sensitization and hence can be classified as non-skin sensitizer.

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