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Diss Factsheets

Administrative data

Description of key information

The test chemical did not induce contact senstization on humans and guinea pigs when tested in skin sensitization est. Hence the test chemical is considered to be not sensitizing to the skin

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
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 for the target chemical is summarized based on data 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: Refer below principle
Principles of method if other than guideline:
WoE for the target CAS is summarized based on data from various test chemicals
GLP compliance:
not specified
Type of study:
other: 2. Patch test; 3. No data
Justification for non-LLNA method:
Not Specified
Species:
other: 2. Human; 3. Guinea pigs
Strain:
other: Not applicable
Sex:
not specified
Details on test animals and environmental conditions:
No data available
Route:
epicutaneous, occlusive
Vehicle:
other: Urea
Remarks:
2
Concentration / amount:
No data available
Day(s)/duration:
46 hours
Adequacy of induction:
not specified
Route:
other: No data available / 3
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: urea
Remarks:
2
Concentration / amount:
No data available
Day(s)/duration:
48 hours
Adequacy of challenge:
not specified
Route:
other: No data available / 3
No. of animals per dose:
No data available
Details on study design:
No data available
Challenge controls:
No data available
Reading:
1st reading
Hours after challenge:
46
Group:
test chemical
Dose level:
No data available / 2
No. with + reactions:
0
Clinical observations:
The chemical did not cause skin sensitization.
Remarks on result:
no indication of skin sensitisation
Remarks:
2
Reading:
1st reading
Group:
test chemical
Dose level:
No data available / 3
No. with + reactions:
0
Clinical observations:
The chemical did not cause skin sensitization in the guinea pigs.
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
other: not sensitizing
Conclusions:
The test chemical did not induce contact senstization on humans and guinea pigs when tested in skin sensitization est. Hence the test chemical is considered to be not sensitizing to the skin.
Executive summary:

Data available for the various test chemicals was reviewed to determine the skin sensitization study of the test chemical. The studies are as mentioned below:

Patch-Test was conducted on humans to determine the degree of contact sensitization caused by the chemical. An aqueous solution of the test chemical (with urea) was negative when applied in a 46-h exposure human skin patch test. The test chemical did not induce contact senstization on humans when tested in a 46-h exposure human skin patch test. Hence the test chemical is considered to be not sensitizing to the skin of human subjects.

In another study, the skin sensitization study of test chemical was studied using guinea pigs to determine the skin sensitization potential of test chemical. When the test chemical was applied dermally to the skin of guinea pig, none of the treated guinea pigs showed the induction of skin sensitization. Hence the test chemical was considered to be not sensitizing to the skin of guinea pig.

.

Based on the data available and applying trhe weight of evidence approach, the test chemical did not induce contact senstization on humans and guinea pigs when tested in skin sensitization test. Hence the test chemical is considered to be not sensitizing to the skin

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

Data available for the various test chemicals was reviewed to determine the skin sensitization study of the test chemical. The studies are as mentioned below:

Patch-Test was conducted on humans to determine the degree of contact sensitization caused by the chemical. An aqueous solution of the test chemical (with urea) was negative when applied in a 46-h exposure human skin patch test. The test chemical did not induce contact senstization on humans when tested in a 46-h exposure human skin patch test. Hence the test chemical is considered to be not sensitizing to the skin of human subjects.

In another study, the skin sensitization study of test chemical was studied using guinea pigs to determine the skin sensitization potential of test chemical. When the test chemical was applied dermally to the skin of guinea pig, none of the treated guinea pigs showed the induction of skin sensitization. Hence the test chemical was considered to be not sensitizing to the skin of guinea pig.

.

Based on the data available and applying trhe weight of evidence approach, the test chemical did not induce contact senstization on humans and guinea pigs when tested in skin sensitization test. Hence the test chemical is considered to be not sensitizing to the skin

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the data available and applying trhe weight of evidence approach, the test chemical did not induce contact senstization on humans and guinea pigs when tested in skin sensitization test. Hence the test chemical is considered to be not sensitizing to the skin

From the results obtained from these studies it is concluded that the chemical Ammonium phosphinate (CAS No: 7803-65-8) is not likely to cause skin sensitization and hence can be classified as non-skin sensitizer.