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EC number: 941-379-0 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Justification for type of information:
- Read across justification included in Section 13
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Justification for type of information:
- Read across justification included in Section 13
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 411 (Subchronic Dermal Toxicity: 90-Day Study)
- GLP compliance:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Type of coverage:
- other: open with elizabethan collars
- Vehicle:
- other: mineral oil
- Details on exposure:
- Route of Administration: dermal
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- Six hours each day
- Frequency of treatment:
- Daily, five days per week for 13 weeks
- Remarks:
- Doses / Concentrations:
165, 330 & 495 mg/kg/day
Basis: - No. of animals per sex per dose:
- 12
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Test material was applied at concentrations of 20, 40 or 60% (v/v) at a rate of 1 ml/kg/day to the shorn intrascapular region of the rats. This was equivalent to doses of test material of 165, 330 or 495 mg/kg/day. Dosing was continued daily for five consecutive days each week, five days a week for 13 weeks. In addition a group of 12 male and 12 female rats of similar age were administered mineral oil at a dose rate of 1 ml/kg/day; these animals served as vehicle controls. An additional 12 rats/sex/group in the vehicle controls and high dose group were maintained for a 4-week recovery period following dosing for 13 weeks. All animals were fitted with collars to prevent ingestion and these were removed six hours after dosing and any residual test or control material was wiped from the skin. Animals were observed for clinical signs prior to dosing and 1, 6 and 24 hours after the first dose. Subsequently, observations were made prior to each dose being applied.
- Sacrifice and pathology:
- A complete necropsy was performed on six rats/sex/group following 13 weeks dosing, and on 6 rats/sex/group of the recovery animals (high dose and controls) at week 18. A limited necropsy was performed on the remaining six animals and their organs were not weighed (see below). Each full necropsy included an examination of the external surface of the body, all orifices, cranial, thoracic, abdominal and pelvic cavities and their contents. Gross observations were recorded and the following organs were weighed: Adrenal glands, brain, epididymides, heart, kidneys, liver, ovaries, prostate, spleen, testes, thymus and uterus.
The following tissues were collected, processed and then examined microscopically. Adrenal glands Nose (nasal cavity & turbinates) Animal identification Ovaries Bone marrow (from sternum) Oviducts Brain Pancreas Epididymides Parathyroid glands Oesophagus Pituitary gland Exorbital lacrimal glands Prostate Eyes with optic nerve Salivary glands Femur (incl. articular surface) Seminal vesicles Gross lesions Skin (application site) Harderian gland Skin (inguinal) Heart and aorta Spinal cord (3 levels) Intestine (3 levels) Spleen Kidneys Stomach Larynx and pharynx Testes Liver Thymus Lungs with mainstream bronchi Thyroid gland Lymph nodes (mandibular/mesenteric) Urinary bladder Mammary glands with adjacent skin Uterus Muscle (thigh) Vagina Nerve (sciatic) The remaining six rats of each group were anesthetized with an intraperitoneal injection of Pentothal ® and transcardially perfused in-situ using 10% neutral-buffered formalin and given a limited necropsy. For these rats, no organs were weighed and the following tissues were collected: Head/skull Sural nerve Brain Tibial nerve Spinal cord Gross lesions Sciatic nerve The following tissues were examined microscopically in these animals: Brain (forebrain, cerebrum, midbrain, cerebellum, pons and medulla obligata) Gasserian ganglia Dorsal root ganglia Dorsal and ventral root fibers Sural nerve Tibial nerve Spinal cord (cervical and lumbar areas) Sciatic nerve. - Other examinations:
- At the 14 week necropsy, blood samples were collected from 12 animals/sex/group and at the week 18 necropsy from the recovery rats (vehicle and high dose groups). The following haematological and clinical chemical parameters were measured. Haematology Erythrocyte count Haemoglobin Haematocrit Mean corpuscular volume Mean corpuscular haemoglobin Mean corpuscular hemoglobin concentration Platelet count Reticulocyte count Total leukocyte count Differential leukocyte count Morphological examination of erythrocytes and platelets Coagulation determinations (prothrombin time & activated partial thromboplastin time) were also carried out on six animals from each group at week 14 and from the recovery groups at the week 18 necropsy.
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- >= 495 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: test material
- Critical effects observed:
- not specified
- Conclusions:
- In a 90-day dermal toxicity study in rats the NOEL was >495 mg/kg/day
- Executive summary:
In a 90-day dermal toxicity study, groups of male and female rats were exposed dermally to hydrodesulphurised kerosine diluted in mineral oil, at treatment rates of 165, 330 or 495 mg/kg/day. There were no deaths during the study and no treatment related efftcts were reported. The NOEL was determined to be >495 mg/kg/day
All
animals survived until scheduled termination. There were no test
substance-related effects on survival, clinical
observations (apart from skin irritation), neurobehavioral
signs or ophthalmological findings. The only clinical observations
during the study were related to skin irritation
at the application site. There was a generally dose-related increase in
the incidence and severity of
erythema, oedema, epidermal scaling, scab formation, thickening of the skin
and ulceration at the treated site. Males
seemed to be more sensitive
than females.
The FOB screen did not demonstrate any substance-related effects. The
areas monitored were: behavioural parameters, including autonomic,
muscle tone and equilibrium, sensorimotor responses, central nervous
system. In
addition the test substance
had little effect on motor activity or startle response.
Growth rates were unaffected by treatment.
At necropsy no substance-related observations were made for males in any
group. In
the females there was a suggestion of a possible treatment-related
effect which occurred in 7 rats across all groups and consisted of skin
crusts or ulceration at the site of application of test material.
Haematological and serum clinical parameters were unaffected by
treatment.
The only organ weight effects noted were an increase in spleen/body
weight and spleen/brain weight ratios in the high dose group females at
the 13 week necropsy and an increase in absolute spleen weight in the
same dose group females after the 4 weeks recovery period. Since
there were no associated
microscopic or clinical chemical findings, these differences were
not considered to be of biological relevance.
There were no treatment-related microscopic changes in the tissues
examined with the exception of the findings in the skin. The
skin observations were minimal in nature with a severity score less than
1 on a 1 [low] to 4 [severe] scale.
The findings included acanthosis, ulceration, parakeratosis, chronic
active inflammation and hyperkeratosis. The
males were affected at all doses, however, the effects indicated very
little irritation. Recovery
group animals revealed complete recovery in the females and minimal
hyperkeratosis in the high dose group males.
No effects were found in the animals subjected to a detailed neuropathological
examination.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 411 (Subchronic Dermal Toxicity: 90-Day Study)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Kerosine (petroleum), hydrodesulfurized
- EC Number:
- 265-184-9
- EC Name:
- Kerosine (petroleum), hydrodesulfurized
- Cas Number:
- 64742-81-0
- IUPAC Name:
- Kerosine (petroleum), hydrodesulfurized
- Reference substance name:
- hydrodesulphurised kerosine
- IUPAC Name:
- hydrodesulphurised kerosine
- Test material form:
- other: dilution in mineral oil
- Details on test material:
- Hydrodesulfurized kerosine
The Hydrodesulfurized kerosine had the following properties.
Boiling point 148.9 °C (300 °F)
Specific gravity 0.825 @ 60 °F
Melting point Not applicable
% volatile 100
Vapour pressure 0.4 mm Hg @ 68 °F
Evaporation rate
(water = 1) Slower
Vapour density (air = 1) 4.7
Viscosity 1.3 - 2.2 cSt @ 100 °F
% solubility in water Negligible
Pour point -34.4 °C (-30 °F)
pH Not determined
Appearance/odour Clear liquid with hydrocarbon odour
The vehicle used was Squibb mineral oil.
For dosing, mixtures of hydrodesulfurized kerosine were
prepared in the mineral oil at concentrations of 20, 40 and
60% (v/v)
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- other: open with elizabethan collars
- Vehicle:
- other: mineral oil
- Details on exposure:
- Route of Administration: dermal
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- Six hours each day
- Frequency of treatment:
- Daily, five days per week for 13 weeks
Doses / concentrations
- Remarks:
- Doses / Concentrations:
165, 330 & 495 mg/kg/day
Basis:
- No. of animals per sex per dose:
- 12
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Test material was applied at concentrations of 20, 40 or 60% (v/v) at a rate of 1 ml/kg/day to the shorn intrascapular region of the rats. This was equivalent to doses of test material of 165, 330 or 495 mg/kg/day. Dosing was continued daily for five consecutive days each week, five days a week for 13 weeks. In addition a group of 12 male and 12 female rats of similar age were administered mineral oil at a dose rate of 1 ml/kg/day; these animals served as vehicle controls. An additional 12 rats/sex/group in the vehicle controls and high dose group were maintained for a 4-week recovery period following dosing for 13 weeks. All animals were fitted with collars to prevent ingestion and these were removed six hours after dosing and any residual test or control material was wiped from the skin. Animals were observed for clinical signs prior to dosing and 1, 6 and 24 hours after the first dose. Subsequently, observations were made prior to each dose being applied.
Examinations
- Sacrifice and pathology:
- A complete necropsy was performed on six rats/sex/group following 13 weeks dosing, and on 6 rats/sex/group of the recovery animals (high dose and controls) at week 18. A limited necropsy was performed on the remaining six animals and their organs were not weighed (see below). Each full necropsy included an examination of the external surface of the body, all orifices, cranial, thoracic, abdominal and pelvic cavities and their contents. Gross observations were recorded and the following organs were weighed: Adrenal glands, brain, epididymides, heart, kidneys, liver, ovaries, prostate, spleen, testes, thymus and uterus.
The following tissues were collected, processed and then examined microscopically. Adrenal glands Nose (nasal cavity & turbinates) Animal identification Ovaries Bone marrow (from sternum) Oviducts Brain Pancreas Epididymides Parathyroid glands Oesophagus Pituitary gland Exorbital lacrimal glands Prostate Eyes with optic nerve Salivary glands Femur (incl. articular surface) Seminal vesicles Gross lesions Skin (application site) Harderian gland Skin (inguinal) Heart and aorta Spinal cord (3 levels) Intestine (3 levels) Spleen Kidneys Stomach Larynx and pharynx Testes Liver Thymus Lungs with mainstream bronchi Thyroid gland Lymph nodes (mandibular/mesenteric) Urinary bladder Mammary glands with adjacent skin Uterus Muscle (thigh) Vagina Nerve (sciatic) The remaining six rats of each group were anesthetized with an intraperitoneal injection of Pentothal ® and transcardially perfused in-situ using 10% neutral-buffered formalin and given a limited necropsy. For these rats, no organs were weighed and the following tissues were collected: Head/skull Sural nerve Brain Tibial nerve Spinal cord Gross lesions Sciatic nerve The following tissues were examined microscopically in these animals: Brain (forebrain, cerebrum, midbrain, cerebellum, pons and medulla obligata) Gasserian ganglia Dorsal root ganglia Dorsal and ventral root fibers Sural nerve Tibial nerve Spinal cord (cervical and lumbar areas) Sciatic nerve. - Other examinations:
- At the 14 week necropsy, blood samples were collected from 12 animals/sex/group and at the week 18 necropsy from the recovery rats (vehicle and high dose groups). The following haematological and clinical chemical parameters were measured. Haematology Erythrocyte count Haemoglobin Haematocrit Mean corpuscular volume Mean corpuscular haemoglobin Mean corpuscular hemoglobin concentration Platelet count Reticulocyte count Total leukocyte count Differential leukocyte count Morphological examination of erythrocytes and platelets Coagulation determinations (prothrombin time & activated partial thromboplastin time) were also carried out on six animals from each group at week 14 and from the recovery groups at the week 18 necropsy.
Results and discussion
Effect levels
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- >= 495 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: test material
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
All
animals survived until scheduled termination. There were no test
substance-related effects on survival, clinical
observations (apart from skin irritation), neurobehavioral
signs or ophthalmological findings. The only clinical observations
during the study were related to skin irritation
at the application site. There was a generally dose-related increase in
the incidence and severity of
erythema, oedema, epidermal scaling, scab formation, thickening of the skin
and ulceration at the treated site. Males
seemed to be more sensitive
than females.
The FOB screen did not demonstrate any substance-related effects. The
areas monitored were: behavioural parameters, including autonomic,
muscle tone and equilibrium, sensorimotor responses, central nervous
system. In
addition the test substance
had little effect on motor activity or startle response.
Growth rates were unaffected by treatment.
At necropsy no substance-related observations were made for males in any
group. In
the females there was a suggestion of a possible treatment-related
effect which occurred in 7 rats across all groups and consisted of skin
crusts or ulceration at the site of application of test material.
Haematological and serum clinical parameters were unaffected by
treatment.
The only organ weight effects noted were an increase in spleen/body
weight and spleen/brain weight ratios in the high dose group females at
the 13 week necropsy and an increase in absolute spleen weight in the
same dose group females after the 4 weeks recovery period. Since
there were no associated
microscopic or clinical chemical findings, these differences were
not considered to be of biological relevance.
There were no treatment-related microscopic changes in the tissues
examined with the exception of the findings in the skin. The
skin observations were minimal in nature with a severity score less than
1 on a 1 [low] to 4 [severe] scale.
The findings included acanthosis, ulceration, parakeratosis, chronic
active inflammation and hyperkeratosis. The
males were affected at all doses, however, the effects indicated very
little irritation. Recovery
group animals revealed complete recovery in the females and minimal
hyperkeratosis in the high dose group males.
No effects were found in the animals subjected to a detailed neuropathological
examination.
Applicant's summary and conclusion
- Conclusions:
- In a 90-day dermal toxicity study in rats the NOEL was >495 mg/kg/day
- Executive summary:
In a 90-day dermal toxicity study, groups of male and female rats were exposed dermally to hydrodesulphurised kerosine diluted in mineral oil, at treatment rates of 165, 330 or 495 mg/kg/day. There were no deaths during the study and no treatment related efftcts were reported. The NOEL was determined to be >495 mg/kg/day
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