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Administrative data

Description of key information

Based on the QSAR prediction done using the Danish (Q)SAR Database, the skin sensitization for test chemical was estimated to be not sensitizing  on guinea pig and humans. Thus it can be concluded that the substance, the test chemical has no skin sensitization effects.

Hence, test chemical can be considered to be not sensitizing to skin.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
calculation (if not (Q)SAR)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
accepted calculation method
Justification for type of information:
data is from authoritative database
Qualifier:
according to guideline
Guideline:
other: Modelling Database
Principles of method if other than guideline:
To estimate the allergenic potential of the test chemical in guinea pigs and humans
GLP compliance:
not specified
Type of study:
other: estimated data
Specific details on test material used for the study:
- Name of test material (as cited in study report): Phenetole
- Molecular Formula: C8H10O
- Molecular Weight: 122.17 g/mol
- Substance type: Organic
- Physical state: Liquid
Species:
other: human
Strain:
not specified
Sex:
not specified
Route:
other: no data
Vehicle:
no data
Adequacy of induction:
not specified
No.:
#1
Route:
other: no data
Vehicle:
no data
Adequacy of challenge:
not specified
No. of animals per dose:
no data available
Details on study design:
no data available
Challenge controls:
no data available
Positive control substance(s):
not specified
Vehicle:
unchanged (no vehicle)
Reading:
1st reading
Group:
test chemical
Clinical observations:
No signs of sensitization observed
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
other: not sensitizing
Conclusions:
Based on the QSAR prediction done using the Danish (Q)SAR Database, the skin sensitization for test chemical was estimated to be not sensitizing on guinea pig and humans. Thus it can be concluded that the substance, the test chemical has no skin sensitization effects.
Hence, test chemical can be considered to be not sensitizing to skin.
Executive summary:

Based on the QSAR prediction done using the Danish (Q)SAR Database, the skin sensitization for test chemical was estimated to be not sensitizing  on guinea pig and humans. Thus it can be concluded that the substance, the test chemical has no skin sensitization effects.

Hence, test chemical can be considered to be not sensitizing to skin.

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

Skin Sensitization

The dermal sensitization potential of the test chemical was assessed based on the available results from the various test chemicals.

Based on the QSAR prediction done using the Danish (Q)SAR Database, the skin sensitization for test chemical was estimated to be not sensitizing  on guinea pig and humans. Thus it can be concluded that the substance, the test chemical has no skin sensitization effects.

Hence, test chemical can be considered to be not sensitizing to skin.

This is supported by the results of a human maximization test conducted to assess the potential of contact allergy caused by the chemical under occlusive condition. The test material was mixed into petrolatum N.F. at 4% concentration and applied to the same forearm sites under occlusion for five alternate-day 48-hour periods. Each application of the test material was preceded by treatment of the patch site with 5% aqueous sodium lauryl sulfate under occlusion.

Following a ten day rest period challenge patches of the test material were applied to fresh sites on the scapular backs under occlusion for 48 hours. The challenge sites were pretreated for one hour with 10% aqueous sodium lauryl sulfate. Clinical evaluations were made at 48 and 72 hours.

The test chemical failed to induce any signs of dermal sensitization after 72 hours of observation. Hence, the test chemical can be considered to be not sensitizing to skin.

The above results are further supported by a study performed on the ingredients of an aqueous cream formulation to detect potential sensitizers present. 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.

By applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Not Classified".

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

By applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Not Classified".