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EC number: 945-893-6 | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985-07-03
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable with restriction because it is an acceptable and well documented study report.
- Justification for type of information:
- Concawe believes that dermal is the most relevant exposure route, and is sufficiently robust, to identify any potential hazards from repeated exposures to petroleum products to be able to adequately manage the potentially associated risks. However, the primary objective of the testing required for REACH is the identification of hazard, for which the default exposure route under the regulation is oral as this is considered to maximise systemic exposure. To address the regulatory exposure route issue, Concawe will review the current data base for evidence of systemic toxicity after dermal exposure and will also conduct a number of oral OECD 422 studies on prioritized substances in each relevant petroleum category. The document attached provides a concise overview of the information to further support the dermal route of exposure and proposed additional work, as part of a larger testing strategy (the strategy document can be found in Annex 13).
Read across justification included in Section 13
Cross-reference
- 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
- Study period:
- 1985-07-03
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable with restriction because it is an acceptable and well documented study report.
- Justification for type of information:
- Concawe believes that dermal is the most relevant exposure route, and is sufficiently robust, to identify any potential hazards from repeated exposures to petroleum products to be able to adequately manage the potentially associated risks. However, the primary objective of the testing required for REACH is the identification of hazard, for which the default exposure route under the regulation is oral as this is considered to maximise systemic exposure. To address the regulatory exposure route issue, Concawe will review the current data base for evidence of systemic toxicity after dermal exposure and will also conduct a number of oral OECD 422 studies on prioritized substances in each relevant petroleum category. The document attached provides a concise overview of the information to further support the dermal route of exposure and proposed additional work, as part of a larger testing strategy (the strategy document can be found in Annex 13).
Read across justification included in Section 13 - 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:
- no
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Not reported
- Age at study initiation: not reported
- Weight at study initiation: not reported
- Fasting period before study: not reported
- Housing: not reported
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
- Type of coverage:
- open
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- TEST SITE
- Area of exposure: back of animals
- % coverage: no reported
- Time intervals for shavings or clippings: weekly
USE OF RESTRAINERS FOR PREVENTING INGESTION: yes. Cardboard Elizabethan collars were fitted to the rats to minimize ingestion of Light Cycle Oil. - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- substance remained on the skin throughout the study.
- Frequency of treatment:
- The rats were treated 5 days a week for 13 consecutive weeks.
- Remarks:
- Doses / Concentrations:
0, 8, 25, 125, and 500 and 1,250 mg/kg/day
Basis:
no data - No. of animals per sex per dose:
- 10 male and 10 female rat were exposed per dose.
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Dose selection rationale: no data
- Rational for animal assignment [if not random]: Toxicity studies by other routes of administration are most frequently conducted in rats because of their predictive value for human risk assessment; therefore rats were chosen as the experimental model for this study. Additionally, since rats have a much shorter lifespan than humans, this study, which covers approximately 1/10 the lifespan of rats, is intended to elicit the toxic phenomena that might occur during occupationl exposure for a similar fraction of the human lifespan.
- Rationale for selecting satellite groups: no data
- Post-exposure recovery period in satellite groups: no data
- Section schedule rationale (if not random):no data - Positive control:
- No data
- Observations and examinations performed and frequency:
- DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Clinical observations were made daily
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: Weekly
BODY WEIGHT: Yes
- Time schedule for examinations: Body weights were taken daily.
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION: No data
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Blood samples were collected from control animals and those dosed at 500 mg/kg/day during weeks 4 and 13.
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: No data
CLINICAL CHEMISTRY: No data
URINALYSIS: No data
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
NEUROBEHAVIOURAL EXAMINATION: No data
CAGE SIDE OBSERVATIONS: No data - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Statistics:
- none reported
- Clinical signs:
- effects observed, treatment-related
- Dermal irritation:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- effects observed, treatment-related
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- CLINICAL SIGNS AND MORTALITY -
Animals dosed at 1250 mg/kg/day were terminated after two weeks due to lack of body weight and thymus weight gain and dermal effects. Observed effects at the site of application were severe erythema, edema, stiff cracking skin (500 mg/kg/day and 1250 mg/kg/day) occurred within one week of exposure. The epidermis began to slough off for those exposed to 1250 mg/kg/day. Rats dosed at 500 /mg/kg/day were reported to experience ulceration, with a moderate degree of chronic inflammation of the skin and hair follicles.
BODY WEIGHT AND WEIGHT GAIN - Body weight effects were reported to be dose-related.
Male and female animals treated at dose level 1250 mg/kg/day and males treated at 500 mg/kg/day gained less weight than the controls. Animals dosed as 1250 mg/kg/day were sacrificed at the end of the second week of treatment, due to their poor appearance. Females dosed at 500 mg/kg/day and males dosed as 125 mg/kg/day had slightly lower body weights than the respective control rats.
FOOD CONSUMPTION - no data
FOOD EFFICIENCY - no data
WATER CONSUMPTION - no data
OPHTHALMOSCOPIC EXAMINATION - no data
HAEMATOLOGY - no data
CLINICAL CHEMISTRY - no data
URINALYSIS - no data
NEUROBEHAVIOUR - no data
ORGAN WEIGHTS -The thymus of male and females animals dosed at 500 mg/kg/day was reported to be smaller than normal, based on visual inspection and weight. The slight reduction in thymus weight in males treated at 125 mg/kg/day was attributed to be a minimal effect of Light Cycle Oil. Compared to the livers of the control animals, the size of the liver in both male and female animals dosed at 500 mg/kg/day was slightly increased.
HISTOPATHOLOGY: NON-NEOPLASTIC: Microscopic examination of the thymus was greater in males than in females. Examination of the thymus of rats treated at 500 mg/kg/day revealed a depletion of lymphocytes and a slight increase in the amount of connective tissue in the thymus; this was most more prevalent in the males than in the females. The reduced thymus size was judged to have resulted from the depletion of lymphocytes within the thymus. Slight decreases in lymphocytes are not easily detected during microscopic examination; therefore, the thymus weight was considered to be the most sensitive indicator of the effect of Light Cycle Oil on the thymus. For males treated at 125 mg/kg/day, there was slight reduction in thymus weight; this was judged to represent a minimal effect of Light Cycle Oil on the thymus. - Dose descriptor:
- NOAEL
- Effect level:
- 25 mg/kg bw/day
- Sex:
- male
- Basis for effect level:
- other: overall effects clinical signs;body weight; haematology; gross pathology; organ weights;
- Dose descriptor:
- NOAEL
- Effect level:
- 125 mg/kg bw/day
- Sex:
- female
- Basis for effect level:
- other: overall effects clinical signs; mortality; body weight; haematology; gross pathology; organ weights (liver and thymus)
- Critical effects observed:
- not specified
- Conclusions:
- The dermal administration of Light Catalytically Cracked Distillate at doses of 125, 500 and/or 1,250 mg/kg/day resulted in reduction in body weight, reduction in thymus weights and an increase in liver weight. Severe erythema and edema was also reported. Histopathologic evaluation was limited to control animals and those dosed at 500 mg/kg/day. A NOEL was calculated as 25 mg/kg/day for males and 125 mg/kg/day for females.
- Executive summary:
In an 90 -day dermal toxicity study, Light Catalytically Cracked Distillate was applied to the shaved skin of 10 males and 10 females per dose at dose levels of 8, 25, 125, and 500 and 1,250 mg/kg/day, for 5 days/week during a 90 -day period.
Dermal treatment with Light Catalytically Cracked Distillate at doses of 125, 500 and/or 1,250 mg/kg/day resulted in reductions in body weight,thymus weight and an increase in liver weight. Severe erythema and edema was also reported. Histopathologic evaluation was limited to control animals and those dosed at 500 mg/kg/day. A NOEL was calculated as 25 mg/kg/day for males and 125 mg/kg/day for females.
This study received a Klimisch score of 2 and is classified as reliable with restrictions because it is an acceptable and well documented study report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 411 (Subchronic Dermal Toxicity: 90-Day Study)
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- 64741-59-9
- Cas Number:
- 64741-59-9
- IUPAC Name:
- 64741-59-9
- Reference substance name:
- Light Catalytically Cracked Distillate
- IUPAC Name:
- Light Catalytically Cracked Distillate
- Test material form:
- other: low viscosity hydrocarbon liquid
- Details on test material:
- - Name of test material (as cited in study report): Light cycle oil (CAS# 64741-59-9)
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Not reported
- Age at study initiation: not reported
- Weight at study initiation: not reported
- Fasting period before study: not reported
- Housing: not reported
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- TEST SITE
- Area of exposure: back of animals
- % coverage: no reported
- Time intervals for shavings or clippings: weekly
USE OF RESTRAINERS FOR PREVENTING INGESTION: yes. Cardboard Elizabethan collars were fitted to the rats to minimize ingestion of Light Cycle Oil. - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- substance remained on the skin throughout the study.
- Frequency of treatment:
- The rats were treated 5 days a week for 13 consecutive weeks.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 8, 25, 125, and 500 and 1,250 mg/kg/day
Basis:
no data
- No. of animals per sex per dose:
- 10 male and 10 female rat were exposed per dose.
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Dose selection rationale: no data
- Rational for animal assignment [if not random]: Toxicity studies by other routes of administration are most frequently conducted in rats because of their predictive value for human risk assessment; therefore rats were chosen as the experimental model for this study. Additionally, since rats have a much shorter lifespan than humans, this study, which covers approximately 1/10 the lifespan of rats, is intended to elicit the toxic phenomena that might occur during occupationl exposure for a similar fraction of the human lifespan.
- Rationale for selecting satellite groups: no data
- Post-exposure recovery period in satellite groups: no data
- Section schedule rationale (if not random):no data - Positive control:
- No data
Examinations
- Observations and examinations performed and frequency:
- DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Clinical observations were made daily
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: Weekly
BODY WEIGHT: Yes
- Time schedule for examinations: Body weights were taken daily.
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION: No data
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Blood samples were collected from control animals and those dosed at 500 mg/kg/day during weeks 4 and 13.
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: No data
CLINICAL CHEMISTRY: No data
URINALYSIS: No data
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
NEUROBEHAVIOURAL EXAMINATION: No data
CAGE SIDE OBSERVATIONS: No data - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Statistics:
- none reported
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Dermal irritation:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- effects observed, treatment-related
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- CLINICAL SIGNS AND MORTALITY -
Animals dosed at 1250 mg/kg/day were terminated after two weeks due to lack of body weight and thymus weight gain and dermal effects. Observed effects at the site of application were severe erythema, edema, stiff cracking skin (500 mg/kg/day and 1250 mg/kg/day) occurred within one week of exposure. The epidermis began to slough off for those exposed to 1250 mg/kg/day. Rats dosed at 500 /mg/kg/day were reported to experience ulceration, with a moderate degree of chronic inflammation of the skin and hair follicles.
BODY WEIGHT AND WEIGHT GAIN - Body weight effects were reported to be dose-related.
Male and female animals treated at dose level 1250 mg/kg/day and males treated at 500 mg/kg/day gained less weight than the controls. Animals dosed as 1250 mg/kg/day were sacrificed at the end of the second week of treatment, due to their poor appearance. Females dosed at 500 mg/kg/day and males dosed as 125 mg/kg/day had slightly lower body weights than the respective control rats.
FOOD CONSUMPTION - no data
FOOD EFFICIENCY - no data
WATER CONSUMPTION - no data
OPHTHALMOSCOPIC EXAMINATION - no data
HAEMATOLOGY - no data
CLINICAL CHEMISTRY - no data
URINALYSIS - no data
NEUROBEHAVIOUR - no data
ORGAN WEIGHTS -The thymus of male and females animals dosed at 500 mg/kg/day was reported to be smaller than normal, based on visual inspection and weight. The slight reduction in thymus weight in males treated at 125 mg/kg/day was attributed to be a minimal effect of Light Cycle Oil. Compared to the livers of the control animals, the size of the liver in both male and female animals dosed at 500 mg/kg/day was slightly increased.
HISTOPATHOLOGY: NON-NEOPLASTIC: Microscopic examination of the thymus was greater in males than in females. Examination of the thymus of rats treated at 500 mg/kg/day revealed a depletion of lymphocytes and a slight increase in the amount of connective tissue in the thymus; this was most more prevalent in the males than in the females. The reduced thymus size was judged to have resulted from the depletion of lymphocytes within the thymus. Slight decreases in lymphocytes are not easily detected during microscopic examination; therefore, the thymus weight was considered to be the most sensitive indicator of the effect of Light Cycle Oil on the thymus. For males treated at 125 mg/kg/day, there was slight reduction in thymus weight; this was judged to represent a minimal effect of Light Cycle Oil on the thymus.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 25 mg/kg bw/day
- Sex:
- male
- Basis for effect level:
- other: overall effects clinical signs;body weight; haematology; gross pathology; organ weights;
- Dose descriptor:
- NOAEL
- Effect level:
- 125 mg/kg bw/day
- Sex:
- female
- Basis for effect level:
- other: overall effects clinical signs; mortality; body weight; haematology; gross pathology; organ weights (liver and thymus)
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The dermal administration of Light Catalytically Cracked Distillate at doses of 125, 500 and/or 1,250 mg/kg/day resulted in reduction in body weight, reduction in thymus weights and an increase in liver weight. Severe erythema and edema was also reported. Histopathologic evaluation was limited to control animals and those dosed at 500 mg/kg/day. A NOEL was calculated as 25 mg/kg/day for males and 125 mg/kg/day for females.
- Executive summary:
In an 90 -day dermal toxicity study, Light Catalytically Cracked Distillate was applied to the shaved skin of 10 males and 10 females per dose at dose levels of 8, 25, 125, and 500 and 1,250 mg/kg/day, for 5 days/week during a 90 -day period.
Dermal treatment with Light Catalytically Cracked Distillate at doses of 125, 500 and/or 1,250 mg/kg/day resulted in reductions in body weight,thymus weight and an increase in liver weight. Severe erythema and edema was also reported. Histopathologic evaluation was limited to control animals and those dosed at 500 mg/kg/day. A NOEL was calculated as 25 mg/kg/day for males and 125 mg/kg/day for females.
This study received a Klimisch score of 2 and is classified as reliable with restrictions because it is an acceptable and well documented study report.
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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