Lubricating oils, used, vacuum distd.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Study period:

Started: may 21, 1979. Ended: june 9, 1980.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The test was performed according to OECD Guideline 401.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Lubricating oils, used

EC Number:

274-635-9

EC Name:

Lubricating oils, used

Cas Number:

70514-12-4

IUPAC Name:

Lubricating oils, used

Details on test material:

Test material was identified as API 79-7, Used Composite Motor Oil, CAS No. 70514-12-4 (Note: CAS No. was not assigned in original reference).

Gravity : 26,4 °API
Flash: 375 °F
Viscosity: 79,85 cSt 100°F
11,94 cSc 210°F
Pour: -45°F
Color: dark

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

10 ml/Kg bw.
25 ml/Kg bw.

No. of animals per sex per dose:

5 rats/males/25 ml/Kg bw.
5 rats/females/25 ml/Kg bw.
5 rats/males/10 ml/Kg bw.
5 rats/females/10 ml/Kg bw.

Control animals:

no

Details on study design:

Feed was withheld overnight prior to dosing. Each rat was weighed the day of dosing and then administered a single dose of the appropriate amount of test material (ml/kg body weight) by means of gavage. The two levels dosed were 10 and 25 ml/kg. Since the 25 ml/kg dose produced no mortality, it was decided that no higher dose levels would be attempted because of volume considerations.
Observations for death or toxic signs were made daily for the duration of the study (14 days). Initial (day O), day 7, and terminal weights were taken and recorded. Gross necropsy was performed on all survivors on day 14.

Statistics:

LD50 calculation: LD50 was not calculated.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 25 mL/kg bw

Based on:

test mat.

Mortality:

No animals died during the 14-day observation period.

Clinical signs:

other: The same toxic signs were seen in both dose groups, increasing in severity with increased dose. Commonly seen were oily urine stains and oily diarrhea; it appeared that the test material was excreted in the urine and feces and because of the oil base, sta

Gross pathology:

No appreciable macroscopic findings were evident in any treated rat.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In conclusion, the LD50 of the test material, when administered to rats as a single dose by oral route, was higher than 25 ml/Kg.
Density of test material was not stated, however motor oil mean density ranges between 0,8 - 1 g/ml. At least 20000 mg/Kg bw were given to animals during the test.
According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, study results indicate that the substance should not be classified for oral acute toxicity.