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Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Data is from OECD HPV SIDS

Data source

Reference
Reference Type:
secondary source
Title:
SIDS Initial Assessment Report
Author:
ICCA-Initiative
Year:
2005
Bibliographic source:
OECD HPV SIDS, 2005

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
Acute dermal toxicity of Phthalimide in rabbit
GLP compliance:
not specified
Test type:
other: No data
Limit test:
no

Test material

Constituent 1
Reference substance name:
Phthalimide
EC Number:
201-603-3
EC Name:
Phthalimide
Cas Number:
85-41-6
IUPAC Name:
1H-isoindole-1,3(2H)-dione
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): Phthalimide
- Molecular formula (if other than submission substance): C8H5NO2
- Molecular weight (if other than submission substance): 147.13 g/mole
- Substance type: Organic
- Physical state: White crystalline leaflets
Purity 99 %
- Impurities (identity and concentrations): 1 %

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Weight at study initiation: 2.2 to 2.4 kg males, and 2.2 kg females

Administration / exposure

Type of coverage:
other: dermal
Vehicle:
corn oil
Details on dermal exposure:
VEHICLE
- Concentration in vehicle: 5010 and 7940 mg/kg bw
- Amount of vehicle (if gavage): No data available
- Justification for choice of vehicle: 40% solution-suspension in corn oil
- Lot/batch no. (if required): No data available
- Purity: No data available

MAXIMUM DOSE VOLUME APPLIED: 5010 and 7940 mg/kg bw

DOSAGE PREPARATION (if unusual): 5010 and 7940 mg/kg bw 40% solution-suspension in corn oil

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: No data available
Duration of exposure:
24 hours
Doses:
5010 and 7940 mg/kg bw
No. of animals per sex per dose:
Total: 3
5010 mg/kg bw: 1 male
7940 mg/kg bw: 1 male, 1 female
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Necropsy of survivors performed:
- Other examinations performed: clinical signs observed.
Statistics:
No data available

Results and discussion

Preliminary study:
No data available
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 7 940 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No effect on survival and clinical sign
Mortality:
No effect on survival of treated male and female rabbits at 7940 mg/kg/day.
Clinical signs:
other: Reduced appetite and activity for one to two days were observed in treated rabbits. The viscera appeared normal at end of 14 day.
Gross pathology:
No data available
Other findings:
No data available

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 was considered to be > 7940 mg/kg/day when New Zealand white male and female rabbits were treated with Phthalimide by dermal application.
Executive summary:

In acute toxicity study,New Zealand white 2 male and 1 female rabbits were treated with Phthalimidein the concentration of5010 and 7940 mg/kg bw40% solution-suspension in corn oilby dermal application and observed for 14 days. No effect on survival of treatedmale and female rabbits were observed at 5010 and 7940 mg/kg bw. Reduced appetite and activity for one to two days were observed in treated rabbits. The viscera appeared normal at end of 14 day.Therefore, LD50 was considered to be> 7940 mg/kg/day when New Zealand white male and female rabbits were treated with Phthalimide by dermal application.