Registration Dossier

Administrative data

Description of key information

Skin sensitisation

Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be concluded that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
experimental data from various test chemicals
Justification for type of information:
Data is summarized based on the available information from various test chemicals.
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
WoE report is based on 2 skin sensitization studies as- WoE-2 and WoE-3.
Skin sensitization test was conducted on humans to determine the potential of skin sensitization caused by the chemical.
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
not specified
Species:
other: Human
Strain:
other: not applicable
Sex:
not specified
Details on test animals and environmental conditions:
not specified
Route:
epicutaneous, occlusive
Vehicle:
other: soap plus borate solution
Remarks:
2
Concentration / amount:
3% of the test chemical
Day(s)/duration:
21 Days
Adequacy of induction:
not specified
Route:
epicutaneous, occlusive
Vehicle:
other: detergent base solution
Remarks:
3
Concentration / amount:
The test material (a 0.5% aqueous solution of a detergent mixture containing 10% chemical) was applied.
Day(s)/duration:
3 week
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: soap plus borate
Remarks:
2
Concentration / amount:
Not Specifed
Day(s)/duration:
24 hours
Adequacy of challenge:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: detergent base solution
Remarks:
3
Concentration / amount:
The test material (a 0.5% aqueous solution of a detergent mixture containing 10% chemical) was applied.
Day(s)/duration:
2 weeks after induction
Adequacy of challenge:
not specified
No. of animals per dose:
2. 72 subjects
3. 70 human subjects
Details on study design:
2. No Data Available
3. MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: No data
- Exposure period: 3 week period
- Test groups: No data
- Control group: The vehicle also was applied as a negative control.
- Site: occlusive patches
- Frequency of applications: series of 9 applications
- Duration: 24 hours'
- Concentrations: 0.5% aqueous solution of a detergent mixture containing 10% chemical

B. CHALLENGE EXPOSURE
- No. of exposures: No data
- Day(s) of challenge: Challenge applications were made 2 weeks later.
- Exposure period: No data
- Test groups: No data
- Control group: The vehicle also was applied as a negative control.
- Site: occlusive patches
- Concentrations: 0.5% aqueous solution of a detergent mixture containing 10% chemical
Challenge controls:
2. Soap plus borate
3. The vehicle also was applied as a negative control.
Positive control substance(s):
no
Remarks:
No positive control was applied.
Positive control results:
No Data Available
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
3% of the test chemical
No. with + reactions:
0
Total no. in group:
72
Clinical observations:
No Clinical observations were seen in the subjects.
Remarks on result:
no indication of skin sensitisation
Remarks:
2
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.5%
No. with + reactions:
0
Total no. in group:
70
Clinical observations:
No skin sensitization was observed
Remarks on result:
no indication of skin sensitisation
Remarks:
3
Interpretation of results:
other: Not sensitizing
Conclusions:
Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be concluded that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.
Executive summary:

The skin sensitization potential was assessed based on the available results from the various test chemicals.These studies have been summarized as below -

 

A skin sensitization study was performed using the test chemical on human subjects so as to identify the sensitizing potential of the test chemical. The test material (3% of the test chemical in a soap plus borate solution was applied under occlusive patches in a series of 9 applications (each of 24 hours' duration) during a 3 week period to 72 human subjects. Challenge applications were made 2 weeks later. The vehicle also was applied as a negative control. No positive control was applied. The test application sites were graded for primary irritation at various intervals. The material did not appear to cause irritation. None of the subjects were sensitized. Hence, based on all the observations and results, it was concluded that the test chemical was not considered to be sensitizing to the human subject, and is thus not likely to be classified for sensitization as per CLP.

 

The above study was supported with another skin sensitization study conducted using the given test chemical in humans by patch test. The test chemical (10% brightener in a detergent base solution) was applied under occlusive patches in a series of 9 applications (each of 24 hours' duration) during a 3 week period to 70 human subjects. Challenge applications were made 2 weeks later. The vehicle also was applied as a negative control. No positive control was applied. The detergent base contained sodium alkylbenzenesulfonate, sodium alkyl sulfate, sodium tripolyphosphate, sodium sulfate and minor ingredients including perfumes. Component concentrations were not listed, but were stated as being within ranges of usual commercial formulations. No skin sensitization was observed in this study. Hence, the given test chemical is not likely to be skin sensitizing to the human skin.

 

Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be considered that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.

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

Skin sensitization

The skin sensitization potential was assessed based on the available results from the various test chemicals.These studies have been summarized as below -

 

A skin sensitization study was performed using the test chemical on human subjects so as to identify the sensitizing potential of the test chemical. The test material (3% of the test chemical in a soap plus borate solution was applied under occlusive patches in a series of 9 applications (each of 24 hours' duration) during a 3 week period to 72 human subjects. Challenge applications were made 2 weeks later. The vehicle also was applied as a negative control. No positive control was applied. The test application sites were graded for primary irritation at various intervals. The material did not appear to cause irritation. None of the subjects were sensitized. Hence, based on all the observations and results, it was concluded that the test chemical was not considered to be sensitizing to the human subject, and is thus not likely to be classified for sensitization as per CLP.

 

The above study was supported with another skin sensitization study conducted using the given test chemical in humans by patch test. The test chemical (10% brightener in a detergent base solution) was applied under occlusive patches in a series of 9 applications (each of 24 hours' duration) during a 3 week period to 70 human subjects. Challenge applications were made 2 weeks later. The vehicle also was applied as a negative control. No positive control was applied. The detergent base contained sodium alkylbenzenesulfonate, sodium alkyl sulfate, sodium tripolyphosphate, sodium sulfate and minor ingredients including perfumes. Component concentrations were not listed, but were stated as being within ranges of usual commercial formulations. No skin sensitization was observed in this study. Hence, the given test chemical is not likely to be skin sensitizing to the human skin.

 

Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be considered that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.

 

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the result obtained from the studies available for the structurally similar read across chemicals, it can be concluded that the test chemical cannot cause skin sensitization and thus cannot be considered as skin sensitizing.