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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
Study period:
10th to 24th June 1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was not conducted in accordance with a recognised guideline, however the study was conducted to GLP and is detailed with good scientific principles and is similar to OECD 401.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name and of test material (as cited in study report): Phenol, tetrapropenyl-, sulfurized, carbonates, calcium salts, overbased
- CAS number of test material (as cited in study report): 122384-87-6
Testing was performed on a commercial sample of this material. Typical purity of this material as distributed in commerce is 50% alkyl phenol sulfideand 50% highly refined lubricant base oil.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Wilmington, Massachusetts
- Age at study initiation: The males were 70 days of age and the females were 77 days of age at the time of dosing.
- Weight at study initiation: The males weighed 289-322 grams, and the females weighed 204-227 grams at the time of dosing.
- Fasting period before study: yes, overnight prior to dosing
- Housing: The animals were housed individually in wire-bottom cages in an air-conditioned room.
- Diet/water (e.g. ad libitum): The animals had free access to Purina Laboratory Rodent Chow #5001 and water except during the overnight period prior to dosing when only water was available.
- Acclimation period: the animals were allowed a conditioning period of 3 weeks prior to dosing in the laboratory.

ENVIRONMENTAL CONDITIONS
- Temperature (°C):22.2-22.8 °C
- Humidity (%): 57.3-65.7%
- Photoperiod (hrs dark / hrs light): The photoperiod consisted of a 12-hour light/dark cycle: lights on at 0630 and off at 1830.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
peanut oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: The test material was diluted in peanut oil at a concentration of 714 mg/ml.
- Lot/batch no. (if required): The peanut oil was a golden liquid, Lot/Batch No. A2B. It was received from Eastman Kodak Company, Rochester, New York and stored at room temperature.
- other: Five fasted animals of each sex were dosed with 7.0 ml/kg of peanut oil and served as the controls.

MAXIMUM DOSE VOLUME APPLIED:
limit dose of 5000 mg/kg b. wt.
Doses:
limit dose of 5000 mg/kg b. wt.
No. of animals per sex per dose:
5/sex/dose
Control animals:
yes
Details on study design:
- Duration of observation period following administration: The animals were dosed approximately four hours after the onset of the light cycle. They were observed frequently for any physiological or behavioral abnormalities on the day of dosing and at least once each weekday morning and late afternoon for 13 days after treatment; on weekends they were observed once daily. On Day 14, the animals were observed once prior to sacrifice.
- Frequency of observations and weighing: The animals were weighed immediately prior to dosing and at 2, 7, and 14 days after treatment. The mean body weights of the treated animals were compared to those of the respective controls using Student's t-test
- Necropsy of survivors performed: yes, all survivors were killed following the 14-day observation period were examined for gross pathological changes. The following organs and tissues were examined: skin, spleen, pancreas, esophagus, stomach, small and large intestine, liver, adrenals, kidneys, gonads, uterus or seminal vesicles, bladder, heart, thymus, salivary glands, lungs, trachea, thyroid, and fat. Abnormal tissues were preserved in 10% (v/v) neutral buffered formalin and submitted for histopathological examination.
- Other examinations performed: Tissues were submitted to Histopathology Reference Laboratory, Oakland, California, for tissue processing and preparation of routine five-micron H&E stained sections. The tissue sections were evaluated for microscopic abnormalities at Chevron Environmental Health Center, Inc.
Statistics:
no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
No signs of toxicity were observed.
Body weight:
There were no significant differences in mean body weights between treated and control animals.
Gross pathology:
Gross pathological changes observed at necropsy were limited to dilated renal pelves in two male and one female treated animals. Upon histopathological examination, hydronephrosis was observed in one male and one female treated animal. Renal lymphocytic infiltration was observed in one control male, These lesions were spontaneous and not related to treatment with the test material.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 was considered to be >5 g/kg (>5000 mg/kg) based on the results.
Executive summary:

In a study conducted broadly in line with OECD guideline 401 and in accordance with GLP, single doses of 5.0 g/kg of the test material diluted in peanut oil at a concentration of 714 mg/ml were administered intragastrically to five fasted male and female rats. No mortality was observed. No signs of toxicity were observed.

The gross pathological and histopathological changes observed were spontaneous and unrelated to treatment with the test material.

The LD50 was considered to be >5 g/kg (>5000 mg/kg) based on the results.