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Diss Factsheets

Administrative data

Description of key information

Data available for the closely related read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical Reaction mass of Benzenamine, N,N-dimethyl- , molybdate, tungstate & phosphates . The studies are as mentioned below:

 

The skin sensitization study of read across chemical was performed in guinea pigs to observed its sensitizing potential. The guinea pigs did not produce any sensitization potential .Thus the test material was considered to be non-sensitizing to the guinea pigs.

 

The above result was further supported by the another skin sensitization study reported by safety assessment report for another read across chemical in guinea pigs to observe the skin sensitization effects of test chemical. In this study, the test animals were treated dermally with 10% solution of test chemical during induction. After induction, treated animals were dermally exposed to challenge concentration of 1 or 2% solutions of test chemical. Since the chemical did not produce any cutaneous reaction at challenge concentrations, the test chemical was considered as not sensitizing to guinea pigs.

 

Based on the above summarized studies for target chemical Reaction mass of Benzenamine, N,N-dimethyl- , molybdate, tungstate & phosphates and its structurally and functionally similar read across substances,it can be concluded that the testchemical 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”.

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 closely related read across 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 of test chemical was determined by performing tests on guinea pigs.
GLP compliance:
not specified
Type of study:
other: 1.skin painting test 2.not specified
Justification for non-LLNA method:
not specified
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
not specified
Route:
other: 1. not specified
Route:
other: 2.Dermal application
Vehicle:
not specified
Concentration / amount:
10%
Day(s)/duration:
not specified
Adequacy of induction:
not specified
Route:
other: 1.not specified
Route:
other: 2.Dermal application
Vehicle:
not specified
Concentration / amount:
1 or 2 %
Day(s)/duration:
not specified
Adequacy of challenge:
not specified
No. of animals per dose:
1.not specified2. MAIN STUDY A. INDUCTION EXPOSURE - Concentrations: 10% B. CHALLENGE EXPOSURE - Concentrations: 1or 2% -
Details on study design:
not specified
Reading:
other: 1.1st reading
Group:
test chemical
No. with + reactions:
0
Clinical observations:
No skin sensitization was observed.
Remarks on result:
no indication of skin sensitisation
Reading:
other: 2.1st reading
Group:
test chemical
Dose level:
1 or 2%
No. with + reactions:
0
Clinical observations:
No skin sensitiation was observed.
Remarks on result:
no indication of skin sensitisation
Cellular proliferation data / Observations:
1.No skin sensitization was observed.2.No skin sensitiation was observed
Interpretation of results:
other: Not sensitizing
Conclusions:
The test material Reaction mass of Benzenamine, N,N-dimethyl- , molybdate, tungstate & phosphates was considered to be not sensitizing to the skin of guinea pigs.
Executive summary:

Data available for the closely related read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical Reaction mass of Benzenamine, N,N-dimethyl- , molybdate, tungstate & phosphates . The studies are as mentioned below:

 

The skin sensitization study of read across chemical was performed in guinea pigs to observed its sensitizing potential. The guinea pigs did not produce any sensitization potential .Thus the test material was considered to be non-sensitizing to the guinea pigs.

 

The above result was further supported by the another skin sensitization study reported by safety assessment report for another read across chemical in guinea pigs to observe the skin sensitization effects of test chemical. In this study, the test animals were treated dermally with 10% solution of test chemical during induction. After induction, treated animals were dermally exposed to challenge concentration of 1 or 2% solutions of test chemical. Since the chemical did not produce any cutaneous reaction at challenge concentrations, the test chemical was considered as not sensitizing to guinea pigs.

 

Based on the above summarized studies for target chemical Reaction mass of Benzenamine, N,N-dimethyl- , molybdate, tungstate & phosphates and its structurally and functionally similar read across substances,it can be concluded that the testchemical 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 closely related read across chemicals has been reviewed to determine the skin sensitization potential of the test chemical Reaction mass of Benzenamine, N,N-dimethyl- , molybdate, tungstate & phosphates . The studies are as mentioned below:

 

The skin sensitization study of read across chemical was performed in guinea pigs to observed its sensitizing potential. The guinea pigs did not produce any sensitization potential .Thus the test material was considered to be non-sensitizing to the guinea pigs.

 

The above result was further supported by the another skin sensitization study reported by safety assessment report for another read across chemical in guinea pigs to observe the skin sensitization effects of test chemical. In this study, the test animals were treated dermally with 10% solution of test chemical during induction. After induction, treated animals were dermally exposed to challenge concentration of 1 or 2% solutions of test chemical. Since the chemical did not produce any cutaneous reaction at challenge concentrations, the test chemical was considered as not sensitizing to guinea pigs.

 

Based on the above summarized studies for target chemical Reaction mass of Benzenamine, N,N-dimethyl- , molybdate, tungstate & phosphates and its structurally and functionally similar read across substances,it can be concluded that the testchemical 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”.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The skin sensitization potential of test substance Reaction mass of Benzenamine, N,N-dimethyl- , molybdate, tungstate & phosphates and itsclosely relatedread across substanceswere observed in various studies. From the results obtained from these studies it is concluded that the chemical Reaction mass of Benzenamine, N,N-dimethyl- , molybdate, tungstate & phosphates is not likely to cause skin sensitization and hence can be classified as non-skin sensitizer.