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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
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 peer-reviewed journal

Data source

Reference
Reference Type:
publication
Title:
Evaluation of the toxicity of polyvinylacetate phthalate in experimental animals
Author:
D.R. Schoneker , C.C. DeMerlis, J.F. Borzelleca
Year:
2003
Bibliographic source:
Food and Chemical Toxicology 41 (2003) 405–413

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as below
Principles of method if other than guideline:
Acute oral toxicity study of Phthalic acid in mice
GLP compliance:
not specified
Test type:
other: No data
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Phthalic acid
EC Number:
201-873-2
EC Name:
Phthalic acid
Cas Number:
88-99-3
Molecular formula:
C8H6O4
IUPAC Name:
Phthalic acid
Specific details on test material used for the study:
- Name of test material (as cited in study report): Phthalic acid
- Molecular formula (if other than submission substance): C8H6O4
- Molecular weight (if other than submission substance): 166.131 g/mole
- Substance type: Organic

Test animals

Species:
mouse
Strain:
other: Albino
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Source: Canadian Breeding Laboratories
- Age at study initiation: No data available
- Weight at study initiation: 18–20 g,
- Fasting period before study: Animals were fasted for a period of 4–16 h prior to treatment.
- Housing: No data available
- Diet (e.g. ad libitum): Purina Rodent Chow food, ad libitum
- Water (e.g. ad libitum): water, ad libitum
- Acclimation period: No data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available

IN-LIFE DATES: From: To: No data available

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 5% gum acacia
Details on oral exposure:
EHICLE
- Concentration in vehicle: 5000 mg/kg bw
- Amount of vehicle (if gavage): No data available
- Justification for choice of vehicle: 5% gum acacia
- Lot/batch no. (if required): No data available
- Purity: No data available

MAXIMUM DOSE VOLUME APPLIED: No data available

DOSAGE PREPARATION (if unusual): Phthalic acid was suspended in 5% gum acacia.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: No data available
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 male , 5 female
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: over the 24-h to 14 day.
- Frequency of observations and weighing: over the 24-h period
- Necropsy of survivors performed: Yes
- Other examinations performed: Mortality, clinical signs and gross pathology were observed
Statistics:
LD50 values were calculated from the mortality data (Litchfield and Wilcoxan, 1949).

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality observed
Mortality:
No mortality was observed in treated mice at 5000 mg/kg bw
Clinical signs:
CNS depression was observed in treated mice.
Body weight:
No data available
Gross pathology:
Inflammation of the gastrointestinal tract was observed in treated mice.
Other findings:
No data available

Applicant's summary and conclusion

Interpretation of results:
other: Not Classified
Conclusions:
LD50 was considered to >5000 mg/kg bw when Albino male and female mice were treated with Phthalic acid orally by gavage.
Executive summary:

In a acute oral toxicity study,Albinomale and female micewere treated withPhthalic acid in the concentration of 5000 mg/kg bw orally by gavage in 5% gum acacia. No mortality was observed in treated mice at 5000 mg/kg bw.CNS depression and Inflammation of the gastrointestinal tract was observed in treated mice. Therefore,LD50 was considered to >5000 mg/kg bw whenAlbino male and female micewere treated withPhthalic acid orally by gavage.