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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: Guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Di(2-ethylhexyl)phthalate
- Physical state: liquid
- Analytical purity: 95%
- Impurities: Results of thinlayer chrotuatography indicated one homogeneous spot, and those of vapor-phase chromatography indicated two minor impurities having a total area less than 0.5% of the major peak.
- Lot/batch No.: GC-2-26-76
- Stability under test conditions: Di(2-ethylhexyl)phthalate mixed with feed is stable for 2 weeks at temperatures of up to 45°C
- Source: W.R. Grace and Company (Fords, NJ)

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: NCI Frederick Cancer Research Center, MD
- Age at study initiation: 5-6 weeks old
- Weight at study initiation: no data but equivalent in each group
- Fasting period before study: no data
- Housing: Rats and mice were housed five per cage in suspended polycarbonate cages equipped with disposable nonwoven fiber filter sheets. Hardwood chip bedding and cages were changed twice weekly, and cage racks were changed every 2 weeks.
- Diet (e.g. ad libitum): powdered Wayne Lab Blox® -meal in stainless-steel, gang-style hoppers that were changed once per week available ad libitum.
- Water (e.g. ad libitum): Water, supplied by an Edstrom automatic watering system available ad libitum.
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-31 (average 23°C)
- Humidity (%): 10-88
- Air changes (per hr): Incoming air was filtered through Tri-Dek 15/40 denier Dacron filters, with 10 room air changes per hour.
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: no data

MAXIMUM DOSE VOLUME APPLIED: no data
Doses:
from 0.8 to 20 g/kg (details not available)
No. of animals per sex per dose:
5 males and 5 females per dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data
Statistics:
not appropriate

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 20 000 mg/kg bw
Mortality:
All animals survived the 14-day observation period.
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information LD0 > 20000 mg/kg bw Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008
Conclusions:
Under these experimental conditions, the oral LD0 of DEHP is higher than 20000 mg/kg in Fisher 344 rats.
Executive summary:

The Acute oral toxicity of di(2-ethylhexyl)phthalate (DEHP) was evaluated in F344 rats according to a protocol similar to the OECD N°401 guideline. Groups of 5 male and 5 female Fisher 344 rats were given a single oral dose of DEHP at doses between 800 to 20000 mg/kg. Following treatment, rats were observed until D14. All animals survived the 14-day observation period. The oral LD0 of DEHP is higher than 20000 mg/kg in rats.