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 for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
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:
not specified
Justification for non-LLNA method:
not specified
Species:
other: humans
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
Not specified
Route:
epicutaneous, occlusive
Vehicle:
other: Aqueous solution
Remarks:
2
Concentration / amount:
No data available
Day(s)/duration:
24 hours
Adequacy of induction:
not specified
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Remarks:
3
Concentration / amount:
2% in petrolatum
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: aqueous solution
Remarks:
2
Concentration / amount:
24 hours
Day(s)/duration:
No data available
Adequacy of challenge:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Remarks:
3
Concentration / amount:
2% in petrolatum
Adequacy of challenge:
not specified
No. of animals per dose:
2. 200 subjects
3. 52 patients
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: no data
- Exposure period:24 hours
- Test groups: 200 subjects
- Control group: no data
- Site: volvar forearms
- Frequency of applications:
- Duration: 10 alternate days
- Concentrations: no data

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: after 14 days
- Exposure period: 24 hours
- Test groups: 200 subjects
- Control group:
- Site: scapular backs
- Concentrations: no data
- Evaluation (hr after challenge): after 24 hours
3. OTHER: The dye was applied in Finn Chambers and read first at 2 or (more commonly) 3 days and again at 4–7 days.
The reactions of the patients were graded as ?+. + and ++ categories.
Challenge controls:
Not specified
Positive control substance(s):
not specified
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
No data available
No. with + reactions:
0
Total no. in group:
200
Clinical observations:
None of the subjects showed any signs of contact sensitization.
Remarks on result:
no indication of skin sensitisation
Remarks:
2
Reading:
1st reading
Hours after challenge:
168
Group:
test chemical
Dose level:
2% in petrolatum
No. with + reactions:
1
Total no. in group:
52
Clinical observations:
1/52 showed questionable reactions, 2 patients showed + reactions and no reactions were observed in the remaining patients.
Remarks on result:
no indication of skin sensitisation
Remarks:
3

Table 1:  Patch test results

 

Chemical

No of patients tested

?+

+

++

4548 -53 -2(2% petrolatum)

52

1

2

0

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:

In different studies, the given test chemical has been investigated for the skin sensitization potential to a greater or lesser extent. The studies are based on in-vivo experiments conducted in humans which have been summarized as below -

 

Draize-Shelanski repeated insult patch test was conducted on 200 human subjects to assess the skin sensitization potential of the test chemical .In this study, the chemical applied to the subject’s volvar forearms (200 subjects) as an aqueous solution for 10 alternate days, for 24-hour periods, followed by a 14-day rest period. Challenge batches were then applied under occlusion to fresh skin sites on the subjects scapular backs for 24 hours. The color did not produce either irritation or allergic responses during the induction phase nor contact dermatitis in the challenge period. Therefore the test chemical was considered to be not sensitizing in a Draize-Shelanski repeated insult patch test conducted on 200 human subjects.

 

The above study is supported with another sensitization study conducted for the test chemical to determined sensitization potential by performing patch tests on humans. 2% test chemical in petrolatum was applied in Finn Chambers to the skin of 52 patients. The reactions were first read at 2 or (more commonly) 3 days and again at 4–7 days. The reactions of the patients were graded as ‘? + ‘, ‘+’ and ‘++’ categories 16 patients were tested with the dye. 1/52 showed questionable reactions, 2 patients showed + reactions and no reactions were observed in the remaining patients. Hence, the test chemical can be considered to be not sensitizing to skin.

 

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.

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

Skin sensitization

In different studies, the given test chemical has been investigated for the skin sensitization potential to a greater or lesser extent. The studies are based on in-vivo experiments conducted in humans which have been summarized as below -

 

Draize-Shelanski repeated insult patch test was conducted on 200 human subjects to assess the skin sensitization potential of the test chemical .In this study, the chemical applied to the subject’s volvar forearms (200 subjects) as an aqueous solution for 10 alternate days, for 24-hour periods, followed by a 14-day rest period. Challenge batches were then applied under occlusion to fresh skin sites on the subjects scapular backs for 24 hours. The color did not produce either irritation or allergic responses during the induction phase nor contact dermatitis in the challenge period. Therefore the test chemical was considered to be not sensitizing in a Draize-Shelanski repeated insult patch test conducted on 200 human subjects.

 

The above study is supported with another sensitization study conducted for the test chemical to determined sensitization potential by performing patch tests on humans. 2% test chemical in petrolatum was applied in Finn Chambers to the skin of 52 patients. The reactions were first read at 2 or (more commonly) 3 days and again at 4–7 days. The reactions of the patients were graded as ‘? + ‘, ‘+’ and ‘++’ categories 16 patients were tested with the dye. 1/52 showed questionable reactions, 2 patients showed + reactions and no reactions were observed in the remaining patients. Hence, the test chemical can be considered to be not sensitizing to skin.

 

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.

 

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.