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Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
disregarded due to major methodological deficiencies
Study period:
Started: april 11, 1994. Ended: may 6, 1994.
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: The study was performed in unusual conditions, which were considered not relevant for assessing the toxicity of the substance at repeated doses.

Data source

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

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The study was conducted for evaluating the dermal toxicity of the test material when applied in repeated doses over a period of two weeks.
GLP compliance:
not specified
Limit test:
no

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)
Details on exposure:
The test material was applied to four-inch square gauze sponges backed by plastic wrap. The sponges and plastic wrap were taped to the shaved area of the animals' backs with porous adhesive tape. The entire trunk of each rabbit was wrapped with elastic tape to prevent slippage of the patches.
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
The rabbits were exposed for 24 hours, at which time the patches were removed and a new dose of test material was applied.
Frequency of treatment:
The rabbits were exposed to the test material for 5 consecutive days followed by a 2 day rest period and then again for 5 consecutive days.
Doses / concentrations
Remarks:
Doses / Concentrations:
8 ml/Kg bw
Basis:
nominal per unit body weight
No. of animals per sex per dose:
4 rats/males/8 ml/Kg bw.
4 rats/females/8 ml/Kg bw.
4 rats/males/untreated control
4 rats/females/untreated control
Control animals:
yes, concurrent no treatment
Details on study design:
Prior to application of test material, the rabbits were shaved free of hair. The shaved area on each animal constituted about 30 percent of the total body surface area.
The daily dosage used for this compound was 8 ml/kg body weight, and an untreated control group. The rabbits were exposed to the test material for five consecutive days followed by a two days rest period and then again for five consecutive days. The test material was applied to four-inch square gauze sponges backed by plastic wrap. The sponges and plastic wrap were taped to the shaved area of the animals' backs with porous adhesive tape. The entire trunk of each rabbit was wrapped with elastic tape to prevent slippage of the patches. The rabbits remained bandaged for 24 hours, at which time the patches were removed and a new dose of test material was applied. This procedure was followed each day of the five days dosing period. During the two days rest period the animals were not dosed.

Examinations

Observations and examinations performed and frequency:
Observations for mortality, local reactions, and behavioral abnormalities were daily made during the 14 days period. Initial and final body weights were recorded.
Sacrifice and pathology:
All animals were killed with T-61 at the termination of the study, subjected to necropsy, and any significant gross pathological alterations were recorded. In addition, the following tissues were submitted for histopathologic examination: skin from the test site, liver, kidney, spleen and urinary bladder.
The collected tissues were fixed in 10% neutral buffered formalin. Afterwards, the tissues were trimmed, embedded in paraffin, sectioned at 4 to 5 microns, af fixed to glass slides, and stained with hematoxylin and eosin.

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
No animal died on study.
Dermal irritation:
effects observed, treatment-related
Description (incidence and severity):
Skin at the test site area was red and irritated. Alopecia was noted on the area surrounding the test site.
Mortality:
mortality observed, treatment-related
Description (incidence):
No animal died on study.
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
The animals in the 8 ml/kg dosage level showed an average weight loss of 0.64 kg. The control animals had an average weight gain of 0.2 kg.
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Description (incidence and severity):
The animals in the 8 ml/kg dosage level showed decreased appetites and became emaciated.
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
effects observed, treatment-related
Description (incidence and severity):
Gross postmortem examination of the test animals revealed three rabbits with congested livers, one rabbit with white spots on the liver, one rabbit with an enlarged spleen, and one rabbit with congested kidneys.
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Description (incidence and severity):
The test material produced the following changes at the test site (skin): acanthosis, chronic inflammation, dermal congestion, dermal edema, and hyperkeratosis that varied in severity from very slight to moderate.
Histopathological findings: neoplastic:
no effects observed

Effect levels

Dose descriptor:
other: dermal toxicity of the substance when applied in repeated dose
Effect level:
8 other: ml/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: The test material caused dermal irritation but resulted in no obvious treatment-related signs in the 8 ml/kg treatment group during the 14 days observation period and at necropsy in the species examined.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The test material Used Composite Motor Oil, caused dermal irritation but resulted in no obvious treatment-related signs in the 8 ml/kg treatment group during the 14 days observation period and at necropsy in the species examined.
Histopathologic examination of tissues from rabbits exposed to 8 ml/kg of the test material revealed evidence of dermal irritation at the test site (skin) when compared to the untreated control animals.
The test was performed through an unstandardized method; therefore, results can not be used for regulatory purpose.
According Regulation CE 1272/2008 data available have to be considered as inconclusive for classification of substance.

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