Lubricating oils, used, vacuum distd.

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of 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 404. The test substance was tested on intact and abraded skin, therefore the test was performed in conditions more severe than OECD test.

Justification for type of information:

An Integrated Testing Strategy was performed so the information and data related to the substance of interest was gathered from scientific literature judged as relevant; a data could be judged as relevant even in the case an experimental study was performed to another substance but considered similar to the substance of interest.

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 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Test protocol presented some differences about test animals number, test sites number, test sites area and duration of treatment. The test material was tested both on intact skin and abraded skin.

GLP compliance:

not specified

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:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0,5 ml/animal.

Duration of treatment / exposure:

24 hours.

Observation period:

At 24 and 72 hours post dose, animals were observed and signs of erythema and edema were scored.

Number of animals:

3 males and 3 females.

Details on study design:

Before application of the test material, the rabbits were examined and clipped free of hair in an area extending from the shoulders to the hips and halfway down either side of the thorax. There were four test sites per animal which were located lateral to the midline of the back (two sites on each side) and approximately 10 cm a part. The day of the study , the test sites on the right anterior and the left posterior of each rabbit were abraded with the tip of an eighteen gauge needle. Abrasions consisted of four incisions , two parallel to the long axis of the rabbit and two at right angles to the first. Incisions penetrated the stratum corneum but not the dermis.
Test areas on the left anterior and the right posterior were left intact. A dose of test material equal to 0.5 ml was measured in a syringe and applied to each of four one-inch square gauze patches. The patches were then applied to the four test sites on each rabbit and secured in place with bandage strips. The rabbits' trunks were then wrapped with plastic wrap and with elastic tape to help prevent movement of the patches. The test substance was kept in contact with the skin for 24 hours. At the end of the exposure period, the wrapping material and patches were removed. Excess test material was removed by wiping (but not washing) the skin with gauze sponges moistened with mineral oil, since the test material was not soluble in water.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

Intact skin

Basis:

mean

Time point:

other: 24 hours

Score:

0.83

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

other: Mean irritation score was 0,83

Results 2

Irritation parameter:

erythema score

Remarks:

Abraded skin

Basis:

mean

Time point:

other: 24 hours

Score:

0.92

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

other: Mean irritation score was 0,92

Results 3

Irritation parameter:

edema score

Remarks:

Intact skin

Basis:

mean

Time point:

other: 24 hours

Score:

0

Max. score:

0

Results 4

Irritation parameter:

edema score

Remarks:

Abraded skin

Basis:

mean

Time point:

other: 24 hours

Score:

0.08

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

other: Mean irritation score was 0,08

Results 5

Irritation parameter:

erythema score

Remarks:

Intact and abraded skin

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

0

Results 6

Irritation parameter:

edema score

Remarks:

Intact and abraded skin

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

0

Irritant / corrosive response data:

Based on the conditions of this assay, the test substance has to be considered minimally irritating.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

According to regulation (CE) 1272/2008, the substance in order to be classified as irritant for the skin has to fulfill the following requirements:
(1) Mean value of ≥ 2,3 - ≤ 4,0 for erythema/eschar or for edema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or
(2) inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or
(3) in some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.
Therefore, according to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, study results indicate that the substance should not be classified for skin irritation/corrosion.