Registration Dossier

Administrative data

Description of key information

Skin Sensitization:

Available data for test material  indicates that it is not likely to cause any dermal sensitization to skin. So test material

can be considered to be not sensitizer to skin and can be classified under the category “Not Classified” as per CLP regulation.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
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 auhtoritative databases
Qualifier:
according to
Guideline:
other: Estimated data
Principles of method if other than guideline:
To estimate the sensitizing potential of test material in guinea pig and human skin.
GLP compliance:
not specified
Type of study:
other: Allergic Contact Dermatitis in Guinea Pig and Human
Species:
other: Guinea Pig and Human
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data available.
Route:
other: No data available.
Vehicle:
not specified
Adequacy of induction:
not specified
No.:
#1
Route:
other: No data available.
Vehicle:
not specified
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
Statistics:
No data available.
Reading:
1st reading
Group:
test group
Clinical observations:
No sensitization observed
Remarks on result:
no indication of skin sensitisation

Table showing allergic dermatitis estimation by three different models i.e, Leadscope, battery and SciQSAR & CASE Ultra,the average results was given by the fourth model i.e, Battery model.

DK

Battery

SciQSAR

CASE Ultra

Leadscope

Allergic dermatitis in humans and guinea pigs

NEG

NEG

NEG

NEG

Domain

IN

IN

IN

IN

                                                                      

Where,

IN = inside applicability domain, NEG = Negative

Interpretation of results:
other: Not sensitizing
Conclusions:
Based on the QSAR prediction done using the Danish (Q)SAR Database, the skin sensitization for test material was estimated to be not sensitizing on guinea pig and humans. Thus it can be concluded that the substance, has non skin sensitization effects and based on the CLP criteria for classification it cannot be classified as sensitizer for skin sensitization effects.
Executive summary:

Skin sensitization effects were estimated by four different models i.e, Battery, Leadscope, SciQSAR and CASE Ultra used within Danish QSAR database for test material. Based on estimation, no skin sensitization reactions were observed in guinea pigs and humans. Therefore, test material was considered to be not sensitizing.

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

Skin Sensitization:

 Various studies have been summarized to determine the ability of the test chemical to cause dermal sensitization in living organisms. These studies include in vivo experimental results on Guinea Pig and Human for the test chemical.

Skin sensitization effects were also estimated by four different models i.e, Battery, Leadscope, SciQSAR and CASE Ultra used within Danish QSAR database for test material .Based on estimation, no skin sensitization reactions were observed in guinea pigs and humans. Therefore, test material was considered to be not sensitizing.

The results from the estimated data are in agreement with indicating a possibility of test material being not sensitizing to skin

A maximization test (Kligman, 1966; Kligman and Epstein, 1975) was carried out with 10% (6900 µg/cm2) test material in petrolatum on 26 male volunteers. Test material was applied under occlusion to the same site on the forearms of 26 male subjects for five alternate day, 48-h periods. Patch sites were pre-treated for 24 h with 5% aqueous sodium lauryl solution (SLS) under occlusion for the initial patch only. After 10–14 day rest period, a challenge patch was applied to a fresh site for 48 h under occlusion.Challenge applications were preceded by 30 minute applications of 5% aqueous SLS under occlusion on the left side whereas is test material was applied without SLS treatment on the right side. No sensitization reactions were observed. Hence, test material was considered to be not sensitizing to skin.

Test material was used to evaluate skin sensitization potential by human maximization test. Test material 16% in petrolatum was applied to skin of 25 human volunteers and observed for dermal reactions (duration of exposure and observation period not mentioned). No skin reactions were observed. Hence,t est material can be considered as not skin sensitizer for human skin.

Available studies for the test chemical indicate a possibility that it is not likely to cause any sensitization to skin. Hence, 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

Available data for test material  indicates that it is not likely to cause any dermal sensitization to skin. So test material

can be considered to be not sensitizer to skin and can be classified under the category “Not Classified” as per CLP regulation.