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: 941-364-9 | 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

Endpoint summary
Administrative data
Description of key information
Guideline acute oral, dermal and inhalation toxicity studies were identified. The L50 / LC50 values determined were as follows:
Oral - 7600 mg/kg
Dermal - > 4300 mg/kg
Inhalation - 4100 mg/m3
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Read across justification included in Section 13
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- GLP compliance:
- not specified
- Test type:
- fixed dose procedure
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories
- Age at study initiation: you adults
- Weight at study initiation: 200 to 400 g
- Fasting period before study: feed was withheld overnight prior to dosage
- Housing: housed individually in suspended cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: two weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported
IN-LIFE DATES: not reported - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: no vehicle
- Amount of vehicle (if gavage): no vehicle
- Justification for choice of vehicle: no vehicle
- Lot/batch no. (if required): no vehicle
- Purity: no vehicle
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg
DOSAGE PREPARATION (if unusual): not reported
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: N/A - Doses:
- 2.5, 5, 10, 15, and 20 mL/kg
- No. of animals per sex per dose:
- 5 animals/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weight was recorded on days 0, 7, and 14
- Necropsy of survivors performed: yes - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 9 mL/kg bw
- 95% CL:
- >= 5.58 - <= 14.51
- Remarks on result:
- other: approx 7600 mg/kg bw
- Mortality:
- Mortality rates of the five dose groups (2.5, 2.0, 10, 15, and 20 mL/kg) were 12.5, 20, 70, 40, and 90% respectively.
- Clinical signs:
- other: Clinical signs observed were oily urine stains and oily diarrhoea, which resulted in hair loss, irritation, redness, and sores. In many cases, the anal area had open sores. In the highest dose (20 mL/kg) the entire ventral side and legs were affected. In
- Gross pathology:
- Rats that survived for the duration of the study had few abnormalities and abnormal signs that were observed included enlarges Peyer's patched on the intestine. In both surviving animals and those that died prematurely, many exhibited mild irritation in their lungs or congestion to fluid filled abcesses. In the animals that died prematurely, almost all had intestinal damage including hemorrhaging in the stomach and thinning of the intestinal walls. A few rats has white spots on their caecums and increased gas was noticed in the gastrointestinal tract.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the test material had an oral LD50 of 9.0 mL/kg (approx 7600 mg/kg) body weight. The test material is not classified according to EU criteria.
- Executive summary:
In an acute oral toxicity study, five groups of ten rats (5 males and 5 females) were given a single dose of the appropriate amount of diesel fuel (marketplace sample) (2.5, 5.0, 10, 15, or 20 mL/kg) via oral gavage. Dose levels were chosen to produce expected mortality rates between 10 and 90%. Signs of mortality and toxicity were observed daily for the duration of the study (14 days). Body weight was measured on days 0 and 7, and upon death. Gross necropsy was performed on each animal when they died or by day 14.
Mortality rates of the five dose groups (2.5, 5, 10, 15, 20 mL/kg) were 12.5, 20, 70, 40, and 90% respectively. Signs of toxicity were observed in all dose groups. Severity increased with increased dose. Clinical signs observed were oily urine stains and oily diarrhoea, which resulted in hair loss, irritation, redness, and sores. In many cases, the anal area had open sores. In the highest dose (20 mL/kg) the entire ventral side and legs were affected. In some instances there was blood around the eyes, nose, and mouth. Other symptoms noted included lethargy, pus, or blood at the urinary orifice. Gross pathology observations were also similar in each dose group. In rats who survived for the duration of the study (14 days), there were few abnormalities. In these rats minor observations included enlarged Peyer's patches on intestines. Both animals that died and survived exhibited mild irritation and congestion in the lungs, in addition to fluid-filled abscesses in the lungs. The majority of the animals that died before day 14 showed intestinal damage including, hemorrhaging, thinning of intestinal walls, and increased gas in the gastrointestinal tract.
Under the conditions of this study, the test material had an oral LD50 of 9.0 mL/kg (approx 7600 mg/kg) and a 95% confidence interval of 5.58 and 14.51 mL/kg. the test material was determined to have a median lethal dose according to the study report. The test material is not classified according to EU criteria.
This study received a Klimisch score of 1and is classified as reliable without restriction because it was conducted similar to guideline study OECD 401.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restrictions because it is GLP compliant and was generally conducted according to OECD 403 guidelines.
- Justification for type of information:
- Read across justification included in Section 13
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Kingston, New York 12484
- Age at study initiation: approx. 6 weeks
- Weight at study initiation: 222 to 317 grams (males), 185 to 246 grams (females)
- Housing: Individual
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 to 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24 °C
- Humidity (%): 24 to 91%
- Air changes (per hr): 23 to 28 per hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: March, 1986 To: June, 1986 - Route of administration:
- other: inhalation: aerosol and vapour mixture
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Details on inhalation exposure:
- Nominal concentrations of test article for each exposure determined gravimetrically. Analytical concentration determined using a gravimetric procedure for aerosol level and MIRAN for the vapour level. Actual exposure level is the sum of the aerosol and vapour level. Actual concentrations of the airborne test article measured near the breathing zone at one hour intervals during the exposure period. Particle size distribution measurements made near the breathing zone at one-hour intervals during the exposure period.
The Plexiglas exposure chamber had a total volume of 100L. The airflow rate (1pm) was 17.5, the air change (min) was 5.7 and the equilibrium time (min) was 26.3. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 2.3, 3.5, or 4.9 mg/L
- No. of animals per sex per dose:
- Ten
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Twice daily observations of test animals, weekly weighing of test animals
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology - Sex:
- female
- Dose descriptor:
- LC50
- Effect level:
- 3.6 mg/L air (analytical)
- Exp. duration:
- 4 h
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- 5.4 mg/L air (analytical)
- Exp. duration:
- 4 h
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 4.1 mg/L air (analytical)
- Exp. duration:
- 4 h
- Mortality:
- Mortality was seen at all doses, within three days following exposure. 11 animals died at the highest dose; 10 animals died at the middle dose; 1 animal died at the lowest dose.
- Clinical signs:
- other: Signs included labored breathing and gasping during exposure, which continued in the week following exposure, as well as reduced activity, eyes closed, oral and nasal discharge, and matted coats. All surviving animals were normal by day 15.
- Body weight:
- Body weight gain was decreased in all surviving animals, but values at day 15 generally indicated recovery from treatment.
- Gross pathology:
- Discoloration of lungs, red staining around snout on spontaneously dying animals.
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The inhalation LC50 was determined to be 5.4 mg/L in males, 3.6 mg/L in females, and 4.1 mg/L in combined sexes. The test material is classified as harmful by inhalation according to EU criteria.
- Executive summary:
In an acute inhalation toxicity study, groups of young adult Sprague-Dawley rats (10 per sex) were exposed by inhalation route to naval distillate for 4 hours at 2.3, 3.5, or 4.9 mg/L of aerosol. Animals then were observed for 14 days.
Animals had laboured breathing and nasal discharge, but survivors were normal by study termination. Following exposure, animals in all groups lost weight, but body weight at study termination indicated recovery. The inhalation LC50 was determined to be 5.4 mg/L in males, 3.6 mg/L in females, and 4.1 mg/L in combined sexes. The test material is classified as harmful by inhalation according to EU criteria.
This study received a Klimisch score of one and is classified as reliable without restrictions because the study was GLP compliant and was generally conducted according to OECD 403 guidelines.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 4 100 mg/m³ air
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1979-09-19 to 1979-10-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restriction because it was conducted according to or similar to guideline study OECD 434.
- Justification for type of information:
- Read across justification included in Section 13
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)
- GLP compliance:
- not specified
- Test type:
- fixed dose procedure
- Limit test:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: L.I.T. Rabbitry
- Age at study initiation: adult
- Weight at study initiation: 2.0 to 2.5 kilograms
- Fasting period before study: no
- Housing: individually housed in stainless steel laboratory cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported
IN-LIFE DATES: not reported - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: rabbit's back
- % coverage: 30%
- Type of wrap if used: plastic wrap secured with porous adhesive tape, the entire trunk was wrapped with elastic tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was wiped to remove excess test material
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 mL
- Concentration (if solution): undiluted
- Constant volume or concentration used: yes
- For solids, paste formed: no
VEHICLE
- Amount(s) applied (volume or weight with unit): no vehicle used
- Concentration (if solution): no vehicle used
- Lot/batch no. (if required): no vehicle used
- Purity: no vehicle used - Duration of exposure:
- 24 hours
- Doses:
- 5 mL of undiluted test material
- No. of animals per sex per dose:
- 4 males and 4 females
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: measured on days 0, 7, and 14
- Necropsy of survivors performed: yes - Preliminary study:
- none performed
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 mL/kg bw
- Remarks on result:
- other: approx > 4300 mg/kg bw/day
- Mortality:
- No rabbits died during the study.
- Clinical signs:
- other: During the 14 day study, erythema followed by a drying and flaking of the skin was observed at the test site in all test rabbits. No signs of systemic toxicity were noted.
- Gross pathology:
- The gross post-mortem examinations at 14 days revealed four rabbits with congested kidneys, two with haemorrhages in the trachea, and one with a congested liver. None of these observations were found to be treatment-related.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 for diesel fuel was > 5 mL/kg bw (approx 4300 mg/kg bw).
- Executive summary:
In an acute dermal toxicity study, 4 male and 4 female New Zealand white rabbits were shaved 24 hours prior to application of test material. This area constituted 30% of the total body surface area. Afterwards, the animals were returned to their stock cages for 24 hours to allow the skin to heal. On testing day, the exposure sites of four animals (2 males and 2 females) were abraded. Minor abrasions were made through the stratum corneum, but not the dermis. A single dose of 5 mL of undiluted test material per kilogram body weight was applied to gauze sponges backed with plastic wrap to help prevent evaporation of the test material. The sponges and plastic wrap were then taped to the shaved area of the rabbit's backs with adhesive tapes. The entire trunk was wrapped with elastic tape and the rabbits were then returned to their cages. After 24 hours, the bandaging was removed and the skin wiped with gauze sponges to remove excess test material. Animals were observed for mortality, local reactions, and behavioural abnormalities daily for 14 days. Body weights were recorded on days 0, 7, and 14. on day 14 all surviving rabbits were subjected to gross necropsy.
During the 14 day study, erythema followed by a drying and flaking of the skin was observed at the test site in all test rabbits. No signs of systemic toxicity were noted. None of the rabbits lost weight during the testing period. The gross post-mortem examinations at 14 days revealed four rabbits with congested kidneys, two with haemorrhages in the trachea, and one with a congested liver. None of these observations were found to be treatment-related. The test material is classified as practically nontoxic.
This study has a Klimisch score of 1 and is classified as reliable without restriction because it was conducted according to or similar to guideline study OECD 434.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Acute toxicity data are available for oral, dermal and inhalation routes. The L50 / LC50 values were as follows:
Oral - 7600 mg/kg
Dermal - > 4300 mg/kg
Inhalation - 4100 mg/m3
Justification for classification or non-classification
The data available do not meet the classification criteria for acute oral and dermal toxicity.
Data on acute inhalation indicate that that material warrants classification as Category 4 inhalation.
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.
