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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study
Cross-reference
Reason / purpose:
reference to same study

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1999
Reference Type:
review article or handbook
Title:
Pthalimide
Author:
OECD SIDS
Year:
2005
Bibliographic source:
SIDS Initial Assessment Report For SIAM 20

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Pthalimide
- Analytical purity: 99.9%

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 5 weeks old rats
- Weight at study initiation: 127-135 g for males; 105-111 g for females
- Fasting period before study: 16-18 hours before dosing
- Diet (e.g. ad libitum): ad libitum (except during fasting period)
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 1% (w/v)


MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw


Doses:
2000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
other: not applicable
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observation of general appearance; body weights were recorded at day 0, 1, 3, 5, 7, 10, 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight histopathology (liver, kidneys, spleen, heart, lung, brain, stomach, intestine, ovary, testis and epididymides)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: rat
Mortality:
No deaths occurred in either males or females
Clinical signs:
No effects were detected in terms of general appearance
Body weight:
No effects were detected in terms of body weights
Gross pathology:
No effects were detected in terms of gross pathology
Other findings:
- Histopathology: No effects occurred in terms of histopathology

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

MHW Japan (1999):

In an acute oral toxicity study fasted male and female Crj:CD rats were administered one dose of 2000 mg/kg bw phthalimide (according to OECD guideline 401, in GLP conditions).

The animals were observed for 14 days after administration. No mortalities occurred. The acute oral LD50 was calculated to be greater than 2000 mg/kg bw. No signs of clinical toxicity were reported.

Based on the study results and according to EU classification criteria, no classification is required.