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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Principles of method if other than guideline:
Administration of test material followed by multiple observation periods.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: clear liquid
- Composition of test material, percentage of components: used as supplied
- Other: specific gravity 0.954

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories
- Age at study initiation: young males
- Weight at study initiation: 321 - 374 g
- Fasting period before study: 18 h
- Housing: 6 per cage
- Diet (e.g. ad libitum): Purina Laboratory Rodent diet ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 35 days

ENVIRONMENTAL CONDITIONS
-Humidity: monitored daily
-Temperature (°C): 20 - 22
- Photoperiod (hrs dark / hrs light): 12 / 12


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: administered as received

Doses:
- 1.0, 1.47, 2.15, 3.16, 4.64, 6.81 and 10.0 g/kg bw
No. of animals per sex per dose:
- 5 animals per dose (n=5)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 1, 2, and 4 h after dosing and daily thereafter for 14 d.
- Frequency of observations and weighing: x2 daily
- Necropsy of survivors performed: yes
- Other examinations performed: mortality rate, body weight, fecal staining, soft stool, urinary staining, nasal discharge, ocular discharge
Statistics:
No

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 10 other: g/kg
Remarks on result:
other: All animals survived.
Mortality:
- Mortality rate 0 %.
Clinical signs:
- Fecal staining and/or soft stool staining were seen 4 hours after dosing in one or two animals in the 1.0, 4.64, 6.81 and 10.0 g/kg dose groups.
- Urinary staining occurred on days 1 and/or 2 in animals receiving doses of 3.16 g/kg and higher.
- Animals at the 1.47 and 2.15 g/kg dose levels exhibited no abnormalities throughout the study, and most animals at other dose levels were free of signs of significant toxicity within 2 or 3 days after dosing.
Body weight:
- Two animals (one each in the 1.47 and 6.81 g/kg groups) exhibited weight loses at day 7 with subsequent weight gains at day 14.
- All other animals exhibited weight gains at days 7 and 14.
Gross pathology:
- Postmortem observations at termination of the study revealed findings similar to those seen in control animals killed by carbon dioxide inhalation or were considered unrelated to administration of the test material.
Other findings:
- Other observations: 1 animal in the 6.81 g/kg dose group exhibited a submandibular lesion from days 7 through 14 which was considered unrelated to the administration of the test material.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
No evidence of acute oral toxicity.
Executive summary:

Male Sprague-Dawley rats were administered a single oral exposure of DTDP (1.0, 1.47, 2.15, 3.16, 4.64, 6.81 and 10.0 g/kg) via oral gavage after an 18 hour fasting period. Assessment for clinical signs of toxicity occurred at 1, 2, and 4 hours after dosing and daily thereafter for 14 days. All animals survived the exposure. There was no evidence of a wasting syndrome as assessed by changes in bodyweight. Clinical signs of urinary staining, fecal staining and stool softening were observed 2 hours post exposure in some dose groups, but these signs were not present by 3 days post exposure. It is concluded that the LD50 is greater than 10.0 g/kg.