Registration Dossier

Administrative data

Description of key information

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical. Based on the summarized data,it can be concluded that the test chemical is unable to cause skin sensitization and considered as not sensitizing. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

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 of read across substances
Justification for type of information:
Data for the target chemical is summarized based on the structurally similar read across 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 of test chemical was determined by performing patch tests on guinea pig and mice.

GLP compliance:
not specified
Type of study:
other: 1.Modified Landsteiner 2.mouse local lymphnode assay (LLNA)
Justification for non-LLNA method:
not applicable
Species:
other: 1.guinea pig 2.mouse
Strain:
other: 1.albino 2.Balb/c
Sex:
not specified
Details on test animals and environmental conditions:
1.no data
2.Details on test animal
TEST ANIMALS
- Source: CLEA Japan (Tokyo, Japan)
- Age at study initiation: Six- to eight-week-old
- Weight at study initiation: No data available
- Housing: No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum): No data available
- Acclimation period: No data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available
Route:
other: 1.epicutaneous
Vehicle:
other: 1.not specified
Concentration / amount:
1.single dose (concentration not mentioned)
Day(s)/duration:
not specified
Adequacy of induction:
not specified
No.:
#1
Route:
other: 1.epicutaneous
Vehicle:
other: 1.not specified
Concentration / amount:
1.single dose (concentration not mentioned)
Day(s)/duration:
1.after rest period of 13 days
Adequacy of challenge:
not specified
No. of animals per dose:
1.no data
2.2.3 mice
Details on study design:
1.Details on study design
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- Concentrations:Single dose


B. CHALLENGE EXPOSURE
- Day(s) of challenge:after rest period of 13 days
- Concentrations:Single dose
Challenge controls:
1.no data
Positive control substance(s):
not specified
Reading:
other: 1st reading
Group:
other: test material
Dose level:
no data
No. with + reactions:
0
Clinical observations:
no skin sensitizing effects were observed in treated animals
Remarks on result:
no indication of skin sensitisation
Reading:
other: 2. SI
Clinical observations:
No indication of skin sensitization .
Remarks on result:
other: value:ca. 0-ca. 0,variability :1-12;test group:stimulation index result was zero for the test group

1. no skin sensitization was observed

2.CELLULAR PROLIFERATION DATA- No proliferation of lymphocye observed.

2.value:ca. 0-ca. 0,variability :1-12;test group:stimulation index result was zero for the test group

Interpretation of results:
other: not sensitizing
Conclusions:
The test chemical was considered to be not sensitizing to the skin on the basis of summarized studies.
Executive summary:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical. The studies are as mentioned below:

The skin sensitization test was carried out in albino guinea pigs to determine the sensitization potential of test chemical by using Modified Landsteiner Method.A single dose of test chemical was applied dermally on skin of each guinea pig during the induction phase.After rest period of 13 days challenge was done .It was observed that the guinea pigs did not exhibit sensitization response at challenge concentrations therefore the test material was considered to be non-sensitizing to the guinea pigs.

Another LLNA test was conducted on male BALB/cA mice for test chemical. On 3 consecutive days the groups of 3 mice were exposed to at 25 µl of 1M of chemical. Acetone/ olive oil, 4:1 were used as a vehicle. Three or five days after the last application, a pair of auricular lymph nodes (LNs) from each mouse was excised for the LLNA. A stimulation index was calculated as the ratio of the BrdU amount in the lymph nodes of chemical-treated mice to that of vehicle-treated mice. Stimulation index variation was observed as 0 for the test chemical.From experiment it was concluded that the test chemical was considered to be non-sensitizing in mice LLNA assay.

Based on the above summarized studies for target chemical and its structurally and functionally similar read across substances,it can be concluded that the test chemical is unable to cause skin sensitization and considered as non-skin sensitizer. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

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

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical. The studies are as mentioned below:

The skin sensitization test was carried out in albino guinea pigs to determine the sensitization potential of test chemical by using Modified Landsteiner Method.A single dose of test chemical was applied dermally on skin of each guinea pig during the induction phase.After rest period of 13 days challenge was done .It was observed that the guinea pigs did not exhibit sensitization response at challenge concentrations therefore the test material was considered to be non-sensitizing to the guinea pigs.

Another LLNA test was conducted on male BALB/cA mice for test chemical. On 3 consecutive days the groups of 3 mice were exposed to at 25 µl of 1M of chemical. Acetone/ olive oil, 4:1 were used as a vehicle. Three or five days after the last application, a pair of auricular lymph nodes (LNs) from each mouse was excised for the LLNA. A stimulation index was calculated as the ratio of the BrdU amount in the lymph nodes of chemical-treated mice to that of vehicle-treated mice. Stimulation index variation was observed as 0 for the test chemical.From experiment it was concluded that the test chemical was considered to be non-sensitizing in mice LLNA assay.

Based on the above summarized studies for target chemical and its structurally and functionally similar read across substances,it can be concluded that the test chemical is unable to cause skin sensitization and considered as non-skin sensitizer. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Justification for classification or non-classification

The skin sensitization potential of test substance and its structurally and functionally similar read across substanceswere observed in various studies. From the results obtained from these studies it is concluded that the chemical is not likely to cause skin sensitization and hence can be classified as non-skin sensitizer.