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EC number: 265-057-8
CAS number: 64741-56-6
A complex residuum from the vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly greater than C34 and boiling above approximately 495°C (923°F).
Two skin (OECD 404) and three eye (OECD 405) irritation studies were identified. Petroleum vacuum residues tested in these studies were not found to be irritating to the skin or eyes of rabbits. A further supporting eye irritation study on asphalt gave similar results. A long term repeat dose inhalation study with rats indicates that exposure to bitumen fume can lead to slight irritation of the respiratory tract (see section 7.5).
Two samples pf
petroleum vacuum residue (CAS# 64741-56-6) were tested for primary skin
irritation (API, 1982a, b). Aliquots of 0.5 mL of the two materials were
slightly warmed to decrease the viscosity and subsequently applied under
occlusion to the skin of 6 male white rabbits. After 24 hours, the
occluding patches were removed and the skin was scored for erythema and
oedema (according to Draize) at 1, 24, 72, 96 hours and at 1 and 2 weeks. The
mean erythema and oedema scores for 24 and 72 hours for both residues
ranged from 0 to 0.1. This
study was performed under occlusion and during 24 hours, rather than 4
hour semi-occluded exposure recommended by current OECD guidelines.
Regardless, mean erythema and oedema scores over the 72 hour period were
low. Consequently, the result from a shorter exposure time will not
meet the criteria for classification.
irritation for two neat petroleum vacuum residues (CAS# 64741-56-6) was
tested in 4 male and 4 female white rabbits (API, 1982a, b). The neat
material (0.1 mL) was placed into the everted eyelid. In one male and
two of the female animals the eye was washed 30 seconds after
application, for 1 minute. The animals were observed for 7 days
following application. In the study with sample 81 -13, the primary eye
irritation score were 2.0, 4.0, 4.2, 1.8, and 0.0 at 1, 24, 48, 72 and
168 hours, respectively for the unwashed eye (6 animals) and 1.3, 5.3,
2.0, 0.7, and 0.0 at 1, 24, 48, 72 and 168 hours, respectively for the
washed eye (3 animals) (API, 1982a). In the study with sample 81 -14,
the primary eye irritation scores were 1.0, 4.7, 1.8, 0.0 and 0.0 at 1,
24, 48, 72 and 168 hours, respectively for the unwashed eye (6 animals)
and 1.3, 3.3, 0.0, 0.0, 0.0 at 1, 24, 48, 72 and 168 hours, respectively
for the washed eye (3 animals). Black material was surrounding the eye
in a number of animals and one male animal, of which the eye was not
washed, showed alopecia around the eye along with dark brown material
(API, 1982b). In addition, one animal had diarrhoea, which was not
considered treatment related (API, 1982b).
irritation data on a sample of asphalt, supports that bitumen is not
irritating to the eyes (ARCO, 1973b). This information is presented in
Justification for selection of skin irritation / corrosion endpoint:
based on no significant irritation in 2 studies
Justification for selection of eye irritation endpoint:
Based on no significant irritation in 3 studies (One key and two supporting)
Based on results of
in-vivo studies, bitumen is not considered to be a skin or eye irritant
and does not meet the criteria for classification and labelling under the
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