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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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Data is from publication.

Data source

Reference
Reference Type:
publication
Title:
Contact allergy to N-hydroxyphthalimide
Author:
S. FREGERT, K. GUSTAFSSON AND L. TRULSSON
Year:
1983
Bibliographic source:
CONTACT DERMATITIS; 9 (1), 84-85,1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: AS mentioned below
Principles of method if other than guideline:
Patch testing on human with 2-hydroxy-1H-isoindole-1,3(2H)-dione in ethanol was evaluted for its skin sensitizing potential.
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
Not specified .

Test material

Constituent 1
Chemical structure
Reference substance name:
N-hydroxyphthalimide
EC Number:
208-358-1
EC Name:
N-hydroxyphthalimide
Cas Number:
524-38-9
Molecular formula:
C8H5NO3
IUPAC Name:
N-hydroxyphthalimide
Details on test material:
SMILES:ON1C(=O)c2ccccc2C1=O
Specific details on test material used for the study:
- Name of test material (as cited in study report): N-hydroxyphthalimide
- Molecular formula : C8H5NO3
- Molecular weight :163.132 g/mol
- Substance type: Organic
- Physical state: Solid

In vivo test system

Test animals

Species:
other: Human
Strain:
other:
Remarks:
Not apllicable.
Sex:
male
Details on test animals and environmental conditions:
Details on test animal
TEST ANIMALS
A 35-year-old man worked as a chemist in a pharmaceutical factory. He had never had any skin problems previously.

Study design: in vivo (non-LLNA)

Induction
Route:
other: patch applied on skin
Vehicle:
other: Ethanol
Concentration / amount:
0.00001 and 0.000001 w/w
Challenge
No.:
#1
Route:
other: patch applied on skin
Vehicle:
other: Ethanol
Concentration / amount:
0.001 and 0.0001w/w
No. of animals per dose:
1 human male
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: No data available.
- Test groups: 1
- Control group: No data available.
- Site: No data available.
- Frequency of applications: No data available.
- Duration: No data available.
- Concentrations: 0.00001 and 0.000001 w/w

B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 4 months
- Exposure period: No data available.
- Test groups: 1
- Control group: 12
- Site: No data available.
- Concentrations: 0.001 and 0.0001 w/w
- Evaluation (hr after challenge): No data available.

OTHER:
Challenge controls:
12 challenge controls were used .
Positive control substance(s):
not specified

Study design: in vivo (LLNA)

Statistics:
No data available.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: challenge
Group:
test chemical
Dose level:
0.001 w/w
No. with + reactions:
1
Total no. in group:
1
Clinical observations:
Skin sensitization was observed
Remarks on result:
positive indication of skin sensitisation
Reading:
other: challenge
Group:
test chemical
Dose level:
0.0001
No. with + reactions:
0
Total no. in group:
1
Clinical observations:
No skin sensitization reaction observed
Remarks on result:
no indication of skin sensitisation

In vivo (LLNA)

Cellular proliferation data / Observations:

CLINICAL OBSERVATIONS:When he was tested 4 months later he showed a positive reaction to N-HPI at a dilution of 0.001 w/w (w/w)but negative at 0.0001 (w/w).

Any other information on results incl. tables

No skin sensitization reaction was observed according to the study. 12 controls showed negative reactions to the dilution 10- 3 (w/w).

Applicant's summary and conclusion

Interpretation of results:
other: Not sensitizing .
Conclusions:
The test substance 2-hydroxy-1H-isoindole-1,3(2H)-dionewas tested for its skin sensitizing potential in human by patch test.The substance 2-hydroxy-1H-isoindole-1,3(2H)-dione (524-38-9)is considered to be not sensitizing to human by patch test .
Executive summary:

Patch test was conducted for 2-hydroxy-1H-isoindole-1,3(2H)-dione (524-38-9) on human .A 2-hydroxy-1H-isoindole-1,3(2H)-dione atdilution of (0.00001)10-5 w/w and (0.000001)10-6 (w/w) in ethanol were applied by using patch on to the skin of an old man. He showedpositive reaction at 0.00001 concentration in ethanol but negative at 0.000001 concentration in ethanol during induction exposure. After a rest period of 4 months. At challenge ,test material at thedilution of (0.001)10-3 and (0.0001)10-4(w/w) in ethanol were applied by using patch on to the skin of same person., He showedpositive reaction at(0.001)10-3concentration in ethanol but negative at(0.0001)10-4concentration in ethanol during challenge. Therefore, the substance 2-hydroxy-1H-isoindole-1,3(2H)-dione (524-38-9)was considered to be not sensitizing to human by Patch test.

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