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Diss Factsheets

Administrative data

Description of key information

None of the ten guinea pigs tested showed a positive response for skin sensitisation, although the test material is a reported human skin sensitizer. 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.

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:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from safety assessment reports
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.
Species:
guinea pig
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
No data available
Route:
other: No data
Vehicle:
no data
Concentration / amount:
No data
Adequacy of induction:
not specified
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
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
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.

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

Various studies have been reviewed to evaluate the degree of dermal sensitization caused by the test chemical in living organisms. These include in vivo experimental studies performed on guinea pigs for the test chemicals. The results are summarized below:

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 skin sensitizer. 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.

This is supported by the results of Guinea pig maximization test performed to deterrmine the sensitization potential of the test chemical. The study was performed according to OECD 406 Guidelines.

10 male and 10 female guinea pigs were used for the study. In induction phase ,0.5 ml of a 0.5% aqueous solution of the test chemical was given by dermal route as occlusive patch for 1hr 3 times in week for total 10 application and also 2 intradermal injections of 0.1 ml Freunds Complete Adjuvant (50%) were given in same duration . After 12 days rest period, challenge application of 0.5 ml of a 0.5% aqueous solution of the test chemical was given by same route for 1hr. The Observations were made after 1, 6, 24, 48 hrs. No signs of dermal sensitization was observed in any of the test animals during the observation period post challenge exposure .Hence it was considered that the test chemical was not skin sensitizing in guinea pig.

The above results are supported by another Guinea pig maximization test performed to evaluate the dermal sensitization potential of the test chemical.

20 guinea pigs per group, control group and test group were used for the study. The preliminary study was carried in which it was  observed that ,25 % aqueous test chemical was the minimum irritant concentration and 10 % aqueous test chemical, the maximum non-irritant concentration after two 24 hours percutaneous occlusive applications.

In induction phase, 5% in aqua dest was used for intradermal induction. After one week dermal induction of 25 % in aqua dest was given. Distinct erythema and oedema formation was observed after intradermal induction.

In challenge phase, 1stchallenge was given two weeks after dermal induction as 10% in aqua dest for 48hr whereas 2nd challenge was done 1 week after 1stdermal challenge. The result was observed 48 h after beginning of test substance application

No skin sensitization reaction observed after 1st and 2ndchallenge in test and control group. Hence, the test chemical was considered as non-skin sensitizing in guinea pig by guinea pig maximization test.

Based on the available data and applying the weight of evidence approach, it can be concluded that the test chemical can be considered to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data and applying the weight of evidence approach, it can be concluded that the test chemical can be considered to be not sensitizing to skin. Thus it can be further classified under the category “Not Classified” as per CLP regulation.