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Toxicological information

Skin sensitisation

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Administrative data

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
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
read-across source
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
Justification for type of information:
Data is from publication
Qualifier:
according to guideline
Guideline:
other: Refer below principle
Principles of method if other than guideline:
A Patch-Test was conducted on humans to determine the degree of contact sensitization caused by the test 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:
No data available
Route:
epicutaneous, occlusive
Vehicle:
other: Urea
Concentration / amount:
No data available
Day(s)/duration:
46 hours
Adequacy of induction:
not specified
Route:
epicutaneous, occlusive
Vehicle:
other: urea
Concentration / amount:
No data available
Day(s)/duration:
48 hours
Adequacy of challenge:
not specified
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
No. with + reactions:
0
Clinical observations:
The chemical did not cause skin sensitization.
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 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.
Executive summary:

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.

Reason / purpose for cross-reference:
read-across source
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
Justification for type of information:
Data is from publication
Qualifier:
according to guideline
Guideline:
other: Refer below principle
Principles of method if other than guideline:
The skin sensitization study of test chemical was studied in guinea pigs to determine the skin sensitization potential of test chemical.
GLP compliance:
not specified
Type of study:
other: 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:
No data available
Route:
other: No data available
Route:
other: No data available
No. of animals per dose:
No data available
Details on study design:
No data available
Challenge controls:
No data available
Reading:
1st reading
Group:
test chemical
Dose level:
No data available
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 senstizing
Conclusions:
The test chemical was considered to be not sensitizing to the skin of guinea pig.
Executive summary:

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.

Data source

Reference
Reference Type:
publication
Title:
WoE of skin sensitization study for CAS no 7803-65-8
Author:
Sustainability Support Services (Europe) AB
Year:
2019
Bibliographic source:
WoE report, Sustainabiliity Support Services (Europe) AB, 2018

Materials and methods

Test guideline
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

Test material

Constituent 1
Chemical structure
Reference substance name:
Ammonium phosphinate
EC Number:
232-266-0
EC Name:
Ammonium phosphinate
Cas Number:
7803-65-8
Molecular formula:
H3N.H3O2P
IUPAC Name:
ammonium phosphinate
Details on test material:
- Name of test material : Ammonium phosphinate
- Molecular formula : H4NO2P
- Molecular weight : 83.0264 g/mol
- Smiles notation : [NH4+].[O-]P=O
- InChl : 1S/H3N.H3O2P/c;1-3-2/h1H3;3H2,(H,1,2)
- Substance type: Inorganic
- Physical state: Solid

In vivo test system

Test animals

Species:
other: 2. Human; 3. Guinea pigs
Strain:
other: Not applicable
Sex:
not specified
Details on test animals and environmental conditions:
No data available

Study design: in vivo (non-LLNA)

Inductionopen allclose all
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
Challengeopen allclose all
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

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
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

Applicant's summary and conclusion

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