Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

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

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:
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, stayed on the fur.
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.