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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:
11th September 1996 to 24th January 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study following GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Phenol, paraalkylation products with C10-15 branched olefins ( C12 rich) derived from propene oligomerization, calcium salts, sulfurized, including distillates (petroleum), hydrotreated, solvent-refined, solvent-dewaxed, or catalyc dewaxed, light or heavy paraffinic C15-C50
EC Number:
701-249-4
Molecular formula:
A molecular formula for this substance does not exist because it is a UVCB. The molecular formula for a theoretical representative structure is C36H58Ca2O4Sx where x = 1-3.
IUPAC Name:
Phenol, paraalkylation products with C10-15 branched olefins ( C12 rich) derived from propene oligomerization, calcium salts, sulfurized, including distillates (petroleum), hydrotreated, solvent-refined, solvent-dewaxed, or catalyc dewaxed, light or heavy paraffinic C15-C50
Details on test material:
122384-85-4/68855-45-8
Phenol, dodecyl-, sulfurized, calcium salts
Testing was performed on a commercial sample of this material. Typical purity of this material as distributed in commerce is 60% alkyl phenol sulfide and 40% highly refined lubricant base oil.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories
- Age at study initiation: approximately 9 to 10 weeks of age
- Weight at study initiation: 209 to 296 g
- Fasting period before study: yes, 17 to 20 hours before test material administration
- Housing: After test material administration, the animals were individually housed in suspended screen-bottom stainless steel cages.
- Diet/water (e.g. ad libitum): The animals were provided continuous access to Laboratory Rodent Diet #5001, PMI Feeds, Inc., and water except for 17 to 20 hours before test material administration when food, but not water, was withheld. The feed is routinely analyzed by the manufacturer for nutritional components and environmental contaminants. Samples of the water are periodically analyzed. There were no known contaminants in the feed or water at levels that could be expected to interfere with or affect the results of the study.
- Acclimation period: the animals were acclimated for a period of at least 7 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 50% ± 20%,
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark lighting cycle

IN-LIFE DATES: From: To: 11th to 25th September 1996

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.5 g/mL
- Amount of vehicle (if gavage): The prepared test material mixture appeared to be a suspension. An individual dose was calculated for each animal based on its fasted body weight and administered by gavage at a volume of 10 mL/kg of body weight.
Doses:
limit dose of 5000 mg/kg b. wt
No. of animals per sex per dose:
5 male/female
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: Clinical observations were conducted at 1, 2.5, and 4 hours after test material administration and daily thereafter for 14 days. Mortality checks were conducted twice a day (morning and afternoon) for 13 days after test material administration and again the morning of Day 14.
- Frequency of observations and weighing: Body weights were determined before test material administration (Day 0), at Day 7, at termination of the in-life phase (Day 14).
- Necropsy of survivors performed: yes, at termination of the in-life phase, all animals were euthanized by an overexposure to carbon dioxide, subjected to an abbreviated gross necropsy examination, and any abnormalities were recorded. After necropsy, the animals were discarded and no tissues were saved as there were no grossly abnormal tissues.
Statistics:
No statistical analyses were required by the protocol.

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 during the study. The estimated oral LD50 values for male and female rats were determined to be greater than 5,000 mg/kg of body weight.
Clinical signs:
Clinical signs of toxicity included red-stained face, soft stool, and dark/yellow-stained urogenital area. All animals returned to a normal appearance by Day 7 after treatment.
Body weight:
All animals exhibited body weight gain throughout the study.
Gross pathology:
There were no lesions observed at the terminal necropsy.

Any other information on results incl. tables

The acute oral toxicity of the test material was evaluated in male and female rats when administered as a single gavage dose at a level of 5,000 mg/kg of body weight. No mortality occurred during the study. The estimated oral LD50 values for male and female rats were determined to be greater than 5,000 mg/kg. Clinical signs of toxicity included red-stained face, soft stool, and dark/yellow-stained urogenital area. All animals returned to a normal appearance by Day 7 after treatment. All animals exhibited body weight gain throughout the study. The gross necropsy examinations at termination revealed no visible lesions,

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 > 5000 mg/ kg b. wt. (males and females)
Executive summary:

In a study conducted in line with OECD guideline 401 under condistions of GLP, the test material was evaluated for its acute oral toxicity potential in male and female rats when administered as a single gavage dose at a level of 5,000 mg/kg of body weight. No deaths occurred during the study. The estimated oral LD50 values for male and female rats were determined to be greater than 5,000 mg/kg. Clinical signs of toxicity included red-stained face, soft stool, and dark/yellow-stained urogenital area. All animals returned to a normal appearance by Day 7 after treatment. All animals exhibited body weight gain throughout the study. The gross necropsy examinations at termination revealed no visible lesions.