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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:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from safety assessment reports

Data source

Reference
Reference Type:
other: Secondary Literature
Title:
Basic Toxicity of 1-Phenyl-3-pyrazolidinone
Author:
National Technical Information Service
Year:
1981
Bibliographic source:
National Technical Information Service, OTS0509696, June 24, 1981

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: As mentioned below
Principles of method if other than guideline:
Guinea pig maximisation test performed for the chemical to evaluate its skin senstisation potential in guinea pigs.
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Guinea pig maximisation test performed for the chemical to evaluate its skin senstisation potential in guinea pigs.

Test material

Constituent 1
Chemical structure
Reference substance name:
1-phenyl-3-pyrazolidone
EC Number:
202-155-1
EC Name:
1-phenyl-3-pyrazolidone
Cas Number:
92-43-3
Molecular formula:
C9H10N2O
IUPAC Name:
1-phenylpyrazolidin-3-one
Test material form:
solid: particulate/powder
Details on test material:
Name of test material (as cited in study report): 1-Phenyl-3-pyrazolidone
Molecular formula: C9H10NO
Molecular weight :162.191 g/mol
Smiles notation : c1ccc(cc1)N2CCC(=O)N2
InChl : 1S/C9H10N2O/c12-9-6-7-11(10-9)8-4-2-1-3-5-8/h1-5H,6-7H2,(H,10,12)
Substance Type: Organic
Physical State: Solid

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
No data available

Study design: in vivo (non-LLNA)

Induction
Route:
other: No data
Vehicle:
no data
Concentration / amount:
No data
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
other: No data
Vehicle:
no data
Concentration / amount:
No data
Adequacy of challenge:
not specified
No. of animals per dose:
10
Details on study design:
No data available
Challenge controls:
No data available
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test chemical
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no effects
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: Not sensitizing
Conclusions:
On a standardized skin sensitization test none of the ten guinea pigs tested showed a positive response when exposed to the test chemical 1-phenyl-3-pyrazolidone.
Executive summary:

Guinea pig maximisation test performed for the test chemical to evaluate its skin senstisation potential. 10 Guinea pigs were used for the test. experiment.

The test chemical was applied to the skin of guinea pigs and observed for effects.

None of the ten guinea pigs tested showed a positive response for skin sensitisation, although the test material is a reported human skinsensitizer. However the estimated human risk of skin sensitization based on the test results is low. Therefore, the test substance was considered to be a non skin sensitiser.