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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
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: Test method was similar to OECD Guideline 402. High concentration of the test substance was tested on intact and abraded skin, therefore the test was performed in conditions more severe than OECD test.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Deviations about study design were adopted.
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:
rabbit
Strain:
New Zealand White
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
About 24 hours.
Doses:
5 ml/Kg bw.
No. of animals per sex per dose:
4 rats/males/5 ml/Kg bw.
4 rats/females/5 ml/Kg bw.
Control animals:
no
Details on study design:
24 hours prior to application of test material, the rabbits were weighed and shaved free of hair with a clipper blade. The shaved area on each animal
constituted about 30 percent of the total body surface area. The animals were then returned to their stock cages. The 24-hour waiting period allows recovery of the stratum corneum from the disturbance which accompanies the close-clipping procedure and also permits healing of any microscopic abrasions possibly produced during the process.
On the testing day, prior to application of test material, the exposure sites of four rabbits (2 males and 2 females) were abraded by making epidermal incisions with an 18-gauge needle every two or three centimeters longitudinally over the area of exposure. The abrasions were minor incisions through the stratum corneum that were not sufficiently deep to disturb the derma or to produce bleeding.
A single dose of 5 ml of test material per kilogram body weight was calculated for each test rabbit, measured in a syringe, and applied to gauze sponges backed with plastic wrap to prevent evaporation of the test material. The sponges and plastic wraps were then taped to the shaved area of the backs with porous adhesive tape. The rabbits were then returned to their cages.
The test material remained in contact with the skin for 24 hours. Behavioral reactions were observed and recorded during the contact period. At the end of 24 hours the bandaging was removed and the skin wiped with gauze sponges to remove excess test material. The exposure sites were examined for local reactions and the animals returned to their stock cages. Observations for mortality, local reactions, and behavioral abnormalities were continued for a total of 14 days following the skin applications.
Initial, 7 and 14 day body weights were recorded. All animals which succumbed during the study were subjected to gross necropsy.
On the 14th day, all surviving rabbits were euthanized and subjected to gross necropsy.
Statistics:
LD50 calculation: LD50 was not calculated.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 mL/kg bw
Based on:
test mat.
Remarks:
applied to intact skin
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 mL/kg bw
Based on:
test mat.
Remarks:
applied to abraded skin
Mortality:
No animals died during the 14-day observation period.
Clinical signs:
No clinical signs or behavioral alterations were noted during the 14-days observation period in any treated animal.
Slight erythema was observed at the application site on the first day.
Body weight:
None of the animals lost weight during the test period.
Gross pathology:
The gross postmortem examinations after 14 days revealed one rabbit with pitted kidneys associated with a common parasite in rabbits. Three rabbits had some fluid in the thoracic cavity and one rabbit showed slightly congested kidneys. The fluid in the thoracic cavity could be due to the T-61 used to euthanize the animals.

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 dermal route, was higher than 5 ml/Kg.
Density of test material was not stated, however motor oil mean density ranges between 0,8 - 1 g/ml. At least 4000 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 dermal acute toxicity.