Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 700-916-7 | 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:
- short-term repeated dose toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- August 21, 1990 - September 18, 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- This study is classified as reliable with restriction because it was conducted to read-across substance. However, the study was conducted according to OECD TG 410 guideline and in accordance with GLP.
- Justification for type of information:
- Read-across justification: Based on the chemical composition, the renewable hydrocarbons produced from raw materials such as fatty acid rich oil like Crude Tall Oil (CTO) or triglyserides, using a hydrotreatment process have similar hydrocarbon fractions and they contain the same critical constituents than fossil diesel fuels. According to the identified hydrocarbon blocks, the typical carbon number ranges and the physicochemical properties, the renewable hydrocarbons with diesel type fractions can be considered as having structural similarities and similar behaviour in contact with water and in the physiological processes than the analogue source substances (fossil diesel fuels). Their irritation properties, skin sensitisation property as well as acute and long-term adverse effects to human health is similar. Therefore, and in order to avoid the unnecessary animal testing, the read-across data from the analogue fossil diesel fuels is used to evaluate skin and eye irritation, the genetic toxicity, carcinogenicity, developmental toxicity and short term and/or long-term toxicological effects of the target substance
Cross-reference
Reference
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- August 21, 1990 - September 18, 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- This study is classified as reliable with restriction because it was conducted to read-across substance. However, the study was conducted according to OECD TG 410 guideline and in accordance with GLP.
- Justification for type of information:
- Read-across justification: Based on the chemical composition, the renewable hydrocarbons produced from raw materials such as fatty acid rich oil like Crude Tall Oil (CTO) or triglyserides, using a hydrotreatment process have similar hydrocarbon fractions and they contain the same critical constituents than fossil diesel fuels. According to the identified hydrocarbon blocks, the typical carbon number ranges and the physicochemical properties, the renewable hydrocarbons with diesel type fractions can be considered as having structural similarities and similar behaviour in contact with water and in the physiological processes than the analogue source substances (fossil diesel fuels). Their irritation properties, skin sensitisation property as well as acute and long-term adverse effects to human health is similar. Therefore, and in order to avoid the unnecessary animal testing, the read-across data from the analogue fossil diesel fuels is used to evaluate skin and eye irritation, the genetic toxicity, carcinogenicity, developmental toxicity and short term and/or long-term toxicological effects of the target substance
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Sasco, Inc., Omaha, Nebraska
- Age at study initiation: Young adult
- Weight at study initiation: Males: 200 to 300 grams; Females: 125 to 200 grams
- Housing: Individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
-Acclimation period: 19 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 26
- Humidity (%): 40 to 70%
- Air changes (per hr): 10 per hour or more
- Photoperiod (hrs dark / hrs light): 12 hour dark/ 12 hour light
IN-LIFE DATES: From:1990-08-20 To: 1990-09-18 - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- TEST SITE
- Area of exposure: Back
- % coverage: 10% of the body surface area
- Type of wrap if used: Latex dental damsecured in place with surgical adhesive tape
- Time intervals for shavings or clippings: As needed during the study
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test article was wiped from the application site
- Time after start of exposure: 6h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.01, 0.05, or 0.5 ml/kg/day adjusted in accordance with the most recent body weight
- Constant volume or concentration used: no
USE OF RESTRAINERS FOR PREVENTING INGESTION: no - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 4 weeks
- Frequency of treatment:
- 6 hours a day, 5 days a week
- Remarks:
- Doses / Concentrations:
0.01, 0.05, or 0.50 mL/kg/day
Basis:
nominal per unit body weight - No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Dose selection rationale: Doses were selected based on a range-finding study.
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Twice a day
- Cage side observations checked for mortality and viability.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Once a week
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: Five days a week just prior to application of the test article, 24 hours after the fifth application, and just prior to necropsy
BODY WEIGHT: Yes
- Time schedule for examinations: Prior to study initiation, three days a week (Monday, Wednesday, and Friday) throughout the dosing period, and at study termination
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No
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
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: At study termination
- Anaesthetic used for blood collection: Yes (halothane)
- Animals fasted: Yes
- How many animals: All surviving animals
- Parameters checked in table 1 were examined
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: At terminal sacrifice
- Animals fasted: Yes
- How many animals: All surviving animals
- Parameters checked in table 1 were examined.
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No
OTHER: Organ weight: Yes. Listed in table 1 - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (see table 2)
HISTOPATHOLOGY: Yes (see table 2) - Statistics:
- Clinical pathology data, terminal organ weights, and organ to body weight ratios were statistically analyzed. Statistical evaluation of equality of means was done by an appropriate one way analysis of variance and a test for ordered response in the dose groups.
For the parametric procedures, a standard one way ANOVA using the F distribution to assess significance was used.
For the nonparametric procedures, the test of equality of means was performed using Kruskal-Wallis test.
Mean Draize irritation scores were plotted by group and time. - Clinical signs:
- no effects observed
- Dermal irritation:
- effects observed, treatment-related
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- 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:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY: There were no treatment-related effects on clinical signs (except dermal irritation) or mortality.
BODY WEIGHT AND WEIGHT GAIN: There were no treatment-related effects on body weight.
HAEMATOLOGY: There were no treatment-related effects on haematology.
CLINICAL CHEMISTRY: There were no treatment-related effects on clinical chemistry.
ORGAN WEIGHTS: There were no treatment-related effects on organ weights.
GROSS PATHOLOGY: At necropsy, the only findings occurred at the treatment site and included dry skin, oedema, and eschar.
HISTOPATHOLOGY: NON-NEOPLASTIC: At the dermal application sites (A and B) there were increased incidences of acanthosis, epidermal crusting, erosion, fibrosis, chronic inflammation, and hyperkeratosis.
OTHER FINDINGS: Dermal irritation occurred in treated animals.
0.01 mL/kg/day: Very slight erythema, slight eschar, and slight dried skin.
0.05 mL/kg/day: Very slight to moderate erythema, slight to moderate eschar, sporadic very slight to slight oedema, and slight to moderately dried skin.
0.50 mL/kg/day: Skin irritation was great enough that the application site changed. For the original site (site A), moderate to severe dermal irritation (erythema, eschar, oedema, dried skin, fissuring, and ulcerations) occurred with a maximum mean daily score of 8.2 in males and 8.1 in females out of a total of 17. These effects decreased after the test site was moved. Similar effects were noted at site B, but the maximum mean daily score was 5.2 in males and 5.4 in females. - Dose descriptor:
- NOEL
- Remarks:
- local
- Effect level:
- < 0.01 other: ml/kg
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: dermal irritation
- Dose descriptor:
- NOEL
- Remarks:
- systemic
- Effect level:
- 0.5 other: ml/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No systemic effects were noted at highest dose level studied.
- Critical effects observed:
- not specified
- Conclusions:
- Thermocracked kerosine was applied dermally at doses 0, 0.01, 0.05 and 0.50 mL/kg bw / day to rats for 28 days. The following NOELS were established: systemic NOEL of 0.50 mL/kg/day ( no effects observed at highest dose tested) and local NOEL of < 0.01 mL/kg/day (dermal irritation at application site).
- Executive summary:
- This study was conducted for the read-across substance, thermocracked kerosine. In a 28-day dermal toxicity study, the test substance was applied to the shaved skin of 10 Sprague-Dawley rats/sex/dose at dose levels of 0, 0.01, 0.05, or 0.5 mL/kg bw/day, 6 hours/day for 5 days/week during a 28-day period. The test compound irritated the skin in a dose-dependent manner. In the high-dose group, the irritation became severe so the application site was moved to a cephalad location at the beginning of the fourth week. There were no compound related effects in mortality, clinical signs, body weight, haematology, clinical chemistry, organ weights, or gross and histologic pathology (except the skin). The LOAEL for dermal irritation is 0.01 mL/kg/day, based on slight to severe dermal irritation occurring at all doses tested. No dermal irritation NOAEL was established. There was no systemic LOAEL, based on the lack of systemic effects. The systemic NOAEL is greater than or equal to 0.5 mL/kg/day.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- F-133 (thermocracked kerosene)
- IUPAC Name:
- F-133 (thermocracked kerosene)
- Reference substance name:
- Naphtha (petroleum), heavy coker
- EC Number:
- 269-778-9
- EC Name:
- Naphtha (petroleum), heavy coker
- Cas Number:
- 68333-23-3
- IUPAC Name:
- Naphtha (petroleum), heavy coker
- Details on test material:
- - Name of test material (as cited in study report): F-133 (thermocracked kerosene), CAS No. 68333-23-3
- Substance type:kerosine
- Physical state: liquid
- Analytical purity: 100 %
- Storage condition of test material: < 80 deg. F.
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: Sasco, Inc., Omaha, Nebraska
- Age at study initiation: Young adult
- Weight at study initiation: Males: 200 to 300 grams; Females: 125 to 200 grams
- Housing: Individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
-Acclimation period: 19 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 26
- Humidity (%): 40 to 70%
- Air changes (per hr): 10 per hour or more
- Photoperiod (hrs dark / hrs light): 12 hour dark/ 12 hour light
IN-LIFE DATES: From:1990-08-20 To: 1990-09-18
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- TEST SITE
- Area of exposure: Back
- % coverage: 10% of the body surface area
- Type of wrap if used: Latex dental damsecured in place with surgical adhesive tape
- Time intervals for shavings or clippings: As needed during the study
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test article was wiped from the application site
- Time after start of exposure: 6h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.01, 0.05, or 0.5 ml/kg/day adjusted in accordance with the most recent body weight
- Constant volume or concentration used: no
USE OF RESTRAINERS FOR PREVENTING INGESTION: no - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 4 weeks
- Frequency of treatment:
- 6 hours a day, 5 days a week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.01, 0.05, or 0.50 mL/kg/day
Basis:
nominal per unit body weight
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Dose selection rationale: Doses were selected based on a range-finding study.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Twice a day
- Cage side observations checked for mortality and viability.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Once a week
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: Five days a week just prior to application of the test article, 24 hours after the fifth application, and just prior to necropsy
BODY WEIGHT: Yes
- Time schedule for examinations: Prior to study initiation, three days a week (Monday, Wednesday, and Friday) throughout the dosing period, and at study termination
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No
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
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: At study termination
- Anaesthetic used for blood collection: Yes (halothane)
- Animals fasted: Yes
- How many animals: All surviving animals
- Parameters checked in table 1 were examined
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: At terminal sacrifice
- Animals fasted: Yes
- How many animals: All surviving animals
- Parameters checked in table 1 were examined.
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No
OTHER: Organ weight: Yes. Listed in table 1 - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (see table 2)
HISTOPATHOLOGY: Yes (see table 2) - Statistics:
- Clinical pathology data, terminal organ weights, and organ to body weight ratios were statistically analyzed. Statistical evaluation of equality of means was done by an appropriate one way analysis of variance and a test for ordered response in the dose groups.
For the parametric procedures, a standard one way ANOVA using the F distribution to assess significance was used.
For the nonparametric procedures, the test of equality of means was performed using Kruskal-Wallis test.
Mean Draize irritation scores were plotted by group and time.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- effects observed, treatment-related
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- 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:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY: There were no treatment-related effects on clinical signs (except dermal irritation) or mortality.
BODY WEIGHT AND WEIGHT GAIN: There were no treatment-related effects on body weight.
HAEMATOLOGY: There were no treatment-related effects on haematology.
CLINICAL CHEMISTRY: There were no treatment-related effects on clinical chemistry.
ORGAN WEIGHTS: There were no treatment-related effects on organ weights.
GROSS PATHOLOGY: At necropsy, the only findings occurred at the treatment site and included dry skin, oedema, and eschar.
HISTOPATHOLOGY: NON-NEOPLASTIC: At the dermal application sites (A and B) there were increased incidences of acanthosis, epidermal crusting, erosion, fibrosis, chronic inflammation, and hyperkeratosis.
OTHER FINDINGS: Dermal irritation occurred in treated animals.
0.01 mL/kg/day: Very slight erythema, slight eschar, and slight dried skin.
0.05 mL/kg/day: Very slight to moderate erythema, slight to moderate eschar, sporadic very slight to slight oedema, and slight to moderately dried skin.
0.50 mL/kg/day: Skin irritation was great enough that the application site changed. For the original site (site A), moderate to severe dermal irritation (erythema, eschar, oedema, dried skin, fissuring, and ulcerations) occurred with a maximum mean daily score of 8.2 in males and 8.1 in females out of a total of 17. These effects decreased after the test site was moved. Similar effects were noted at site B, but the maximum mean daily score was 5.2 in males and 5.4 in females.
Effect levels
open allclose all
- Dose descriptor:
- NOEL
- Remarks:
- local
- Effect level:
- < 0.01 other: ml/kg
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: dermal irritation
- Dose descriptor:
- NOEL
- Remarks:
- systemic
- Effect level:
- 0.5 other: ml/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No systemic effects were noted at highest dose level studied.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Thermocracked kerosine was applied dermally at doses 0, 0.01, 0.05 and 0.50 mL/kg bw / day to rats for 28 days. The following NOELS were established: systemic NOEL of 0.50 mL/kg/day ( no effects observed at highest dose tested) and local NOEL of < 0.01 mL/kg/day (dermal irritation at application site).
- Executive summary:
- This study was conducted for the read-across substance, thermocracked kerosine. In a 28-day dermal toxicity study, the test substance was applied to the shaved skin of 10 Sprague-Dawley rats/sex/dose at dose levels of 0, 0.01, 0.05, or 0.5 mL/kg bw/day, 6 hours/day for 5 days/week during a 28-day period. The test compound irritated the skin in a dose-dependent manner. In the high-dose group, the irritation became severe so the application site was moved to a cephalad location at the beginning of the fourth week. There were no compound related effects in mortality, clinical signs, body weight, haematology, clinical chemistry, organ weights, or gross and histologic pathology (except the skin). The LOAEL for dermal irritation is 0.01 mL/kg/day, based on slight to severe dermal irritation occurring at all doses tested. No dermal irritation NOAEL was established. There was no systemic LOAEL, based on the lack of systemic effects. The systemic NOAEL is greater than or equal to 0.5 mL/kg/day.
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.

EU Privacy Disclaimer
This website uses cookies to ensure you get the best experience on our websites.