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EC number: 927-344-2
CAS number: -
Genetic Toxicity in vitro - Negative
- Bacterial reverse mutation assay (OECD TG 471)
Genetic Toxicity in vitro - Negative - In vitro Mammalian
Chromosome Aberration Test (OECD TG 473)
Genetic Toxicity in vitro - Negative - In vitro Mammalian
Cell Gene Mutation Test (OECD TG 476)
Genetic Toxicity in vitro - Negative - In vitro Sister
Chromatid Exchange Assay in Mammalian Cells (OECD TG 479) - Read-Across
from Hydrodesulfurized Kerosene
An Ames Salmonella typhimurium assay
was performed to assess the mutagenicity of BP 8313. Duplicate testing
was performed on the strains TA 1535, TA 1537, TA 1538, TA 98, and TA
100, both in the presence and absence of metabolic activation. Test
concentrations were between 8-5000 ug/plate. Positive controls
substances were benzo(a)pyrene, 2 -nitrofluorene, 2 -aminoanthracene, 9
-aminoacridine, and N-methyl-N'-nitro-N-nitrosoguanadine. Positive
control cultures had significantly increased number of revertant
colonies. Test substance cultures exhibited no increase in the number of
revertant colonies as compared to negative controls in cultures either
with or without metabolic activation. The test substance is not
An in vitro cytogenic assay was
performed on human peripheral lymphocytes to evaluate the clastogenicity
of BP 8313. The cells were exposed to 1.2, 6.0, or 30.0 µg/ml of the
test substance for 24 hrs, both with and without metabolic activation.
Cyclophosphamide was used as a positive control. 100 metaphases were
examined from each culture for chromosomal aberrations, and the mitotic
index calculated. Since there was little difference in results for
cultures with and without metabolic activation, the data were pooled for
the statistical analysis. The positive control substance induced
significant increases in chromosomal aberrations. The test substance did
not increase the number of aberrations in human peripheral lymphocytes
as compared to negative controls. The test substance is not clastogenic
either in the presence or absence of S-9.
It was concluded that the test material was
negative in the SCE assay.
Genetic Toxicity in vivo - Negative -
Micronucleus Assay in Mouse Bone Marrow (OECD TG 474) - Read-Across from
Jet Fuel A
Genetic Toxicity in vivo - Negative - Mammalian Bone Marrow
Chromosome Aberration Test (OECD TG 475)
Kerosenes were tested in the mammalian bone
marrow micronucleus assay using CD-1 mice. The test materials weretested
at 24, 48, and 72 hour intervals following exposure and did not induce a
statistically significant decrease in the mean percent of polychromatic
erythrocytes or an increase in the mean number of micronucleated
polychromatic erythrocytes. Both the positive
(cyclophosphamide) and the negative (carrier) controls behaved in an
appropriate manner. These data indicate that kerosenes are not
cytotoxic and are not clastogenic in CD-1 mouse bone marrow cells at
doses up to and including 5.0 g/kg of body weight.Classification
is not warranted under the new Regulation (EC) 1272/2008 on
classification, labeling, and packaging of substances and mixtures (CLP)
or under the Directive 67/518/EEC for dangerous substances and Directive
1999/45/EC for preparations.
Cyclophosphamide (200 mg/kg)
White Spirit (0.01mL i.p.)
White Spirit (0.05mL i.p.)
White Spirit (0.1mL i.p.)
White Spirit (50g/m3 by inhalation)
The ability of white spirit to produce
chromosomal aberrations in vivo in mammalian somatic cells was studied
by examining eight-week-old BALB/c male and female mice for the presence
of micronuclei in the polychromatic erythrocytes from bone marrow.
The animals were sacrified 30 h after i.p.
injection of 0.l, 0.05 or 0.01 ml of white spirit. In addition, male
animals were allowed to inhale 50 g/m3 of white spirit, during 5 periods
of 5 min spaced by intervals of 5min. According to Carpenter et al.
(1975) 50 g/m3 represents about 50 times the limit of toxicity. Animals
given 200 mg cyclophosphamide per kg b.w. were used as positive controls. When
compared to control animals, it was concluded that white spirits are not
mutagenic or clastogenic.
Carpenter C. P., Kinkead E. R., Geary, Jr.
D. L., Sullivan L. J., and King J. M. Petroleum Hydrocarbon Toxicity
Studies.Animal and Human Response to Vapors of Stoddard Solvent. 1975.
Toxicology and Applied Pharmacology. 32: 282-297.
C9-14 Aliphatics (2-25% Aromatics) are not
mutagenic using in vitro or in vivo genotoxicity assays.
Further data derived from read across data from the supporting
substances (structural analogue or surrogate), kerosene and jet fuel,
also support the conclusion that C9-14 Aliphatics (2-25% Aromatics) are
not genotoxic. In bacterial reverse mutation tests, C9-14 Aliphatics
(2-25% Aromatics) were not mutagenic in the presence or absence of
metabolic activation. Likewise, there were no mutagenic effects reported
in an in vitro mammalian gene mutation test (HGPRT forward
mutation assay). No in vitro chromosomal effects were
reported in a Chinese hamster ovary assay that examined hydrodesufurized
kerosene. The test substance, C9-14 Aliphatics (2-25% Aromatics), did
not produce chromosomal effects when tested in an in vivo mouse
bone marrow micronucleus assay. These data demonstrate that these
substances are not categorizable genotoxins either in vitro or in
vivo. Furthermore, no there evidence of hyperplastic responses or
pre-neoplastic lesions in sub-chronic and chronic repeat-dose studies in
C9-14 Aliphatics (2-25% Aromatics). All studies were conducted in a
manner similar or equivalent to currently established OECD guidelines.
C9-14 Aliphatics (2-25% Aromatics) are a non-genotoxic agent and
classification is not warranted.
The negative results using in vitro
and in vivo genotoxicity assays do not warrant the classification
of C9-14 Aliphatics (2-25% Aromatics) fluids as genotoxins under the new
Regulation (EC) 1272/2008 on classification, labeling and packaging of
substances and mixtures (CLP) or under the Directive 67/518/EEC for
dangerous substances and Directive 1999/45/EC for preparations.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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