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EC number: 942-492-8 | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 May - 19 June 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam distillation condensate
- Molecular formula:
- Substance is a UVCB and cannot be defined by molecular and structural information
- IUPAC Name:
- Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes, steam distillation condensate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Batch No: 02 November 2020
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: In-house bred animals
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9-10 weeks
- Weight at study initiation: 161.15 g to 178.85 g
- Fasting period before study: fasted overnight (16 to 18 hours)
- Housing: Three animals were housed in standard polysulphonate cage (Size: L 430 x B 280 x H 210 mm) with stainless steel mesh top grill having facilities for holding pelleted feed and drinking water in water bottle fitted with stainless steel sipper tube. Clean sterilized paddy husk was provided as bedding material.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: Healthy young adult animals used for Sighting Study I, Sighting Study II and Main Study were acclimatized for five, seven and nine days respectively to laboratory condition prior to treatment and were observed for clinical signs once daily.
- Method of randomisation in assigning animals to test and control groups
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.6°C to 22.8°C
- Humidity (%): 46% to 64%
- Air changes (per hr): 12 to 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours fluorescent light and 12 hours dark cycle.
IN-LIFE DATES: From: 19 May To: 7/06/2021
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 and 200 mg/mL
- Amount of vehicle (if gavage): 5 ml
- Justification for choice of vehicle: As per the in-house miscibility test, test item is miscible in corn oil. Corn oil is universally accepted and routinely used vehicle in oral toxicity studies.
- Lot/batch no. (if required): N12009002
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
- Rationale for the selection of the starting dose: A starting dose of 300 mg/kg body weight was selected from the fixed dose levels of 5, 50, 300 and 2000 mg/kg body weight because of unavailability of sufficient toxicological data on the test item - Doses:
- The test item was administered through oral gavage as a single dose of 300 mg/kg body weight to one female rat in Sighting study I. No clinical signs of toxicity and mortality was observed. Hence, as per the decision rules governing the sequential procedure presented in the OECD 420 test guideline, Sighting Study II was conducted using one female rat after approximately 24 hours of observation by administering a single dose of 2000 mg/kg body weight of the test item. No clinical signs of toxicity and mortality was observed. Hence, Main study was conducted using four female rats after approximately 24 hours of observation by administering a single dose of 2000 mg/kg body weight of the test item. No clinical signs of toxicity and mortality was observed.
Dose levels higher than 2000 mg/kg body weight were not tested. - No. of animals per sex per dose:
- 1 animal for sighting study at 300 mg/kg bw
5 animals for main studyat 2000 mg/kg bw
Total of 6 females were received. - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All the animals were observed for clinical signs of toxicity and mortality at 20 to 30 mins, 1 hr (±10 mins), 2 hrs (±10 mins), 3 hrs (±10 mins) and 4 hrs (±10 mins) post dosing on day 1 and once daily thereafter for clinical signs of toxicity and twice daily for mortality during the 14 days observation period.
- Necropsy of survivors performed: yes, at the end of observation period, all the surviving animals were sacrificed under carbon dioxide asphyxiation, subjected to necropsy and a complete gross pathological examination and the observations were recorded. Observations included changes in skin, fur, eyes and mucous membranes and also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern.
- Clinical signs including body weight : Individual animal body weight was recorded at receipt, on day 1 (before test item administration) and on days 8 and day 15 during the observation period.
- Other examinations performed: Histopathological examination was not carried out as there were no gross lesions observed.
Results and discussion
- Preliminary study:
- The test item was administered through oral gavage as a single dose of 300 mg/kg body weight to one female rat in Sighting study I. No clinical signs of toxicity and mortality was observed.
,Sighting Study II was conducted using one female rat after approximately 24 hours of observation by administering a single dose of 2000 mg/kg body weight of the test item. No clinical signs of toxicity and mortality was observed.
Main study was conducted using four female rats after approximately 24 hours of observation by administering a single dose of 2000 mg/kg body weight of the test item. No clinical signs of toxicity and mortality was observed.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred
- Clinical signs:
- other: No clinical signs of toxicity and mortality were observed in any of the dosed animals.
- Gross pathology:
- No gross pathological changes were observed in any of the dosed animals.
- Other findings:
- N/A
Any other information on results incl. tables
TABLE 1. INDIVIDUAL ANIMAL CLINICAL SIGNS OF TOXICITY AND MORTALITY RECORD
Study Steps & Dose (mg/kg body weight) | Animal No. | Sex | Time of Dosing (AM) | Clinical Signs of Toxicity and Mortality on Day 1 | Clinical Signs of Toxicity and Mortality on Day | |||||||||||||||||
20 to 30 min | 1 hr (±10 min) | 2hrs (±10 min) | 3hrs (±10 min) | 4hrs (±10 min) | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | ||||
Sighting Study I & 300 | Rf6896 | F | 11:16 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
Sighting Study II & 2000 | Rf6897 | F | 11:08 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
Main Study & 2000 | Rf6898 | F | 10:53 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
Rf6899 | F | 10:53 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rf6900 | F | 10:53 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rf6901 | F | 10:54 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
N: Normal; F: Female; min/mins: minutes; hr/hrs: Hour/Hours
TABLE 2. INDIVIDUAL ANIMAL BODY WEIGHT (g) AND PERCENT CHANGE IN BODY WEIGHT WITH RESPECT TO DAY 1
Study Steps & Dose (mg/kg body weight) | Animal No. | Sex | Volume Administered (mL) | Body Weight (g) on Day | Percent Change in Body Weight with Respect to Day | ||||
1 | 8 | 15 |
| 1 to 8 | 1 to 15 | ||||
Sighting Study I & 300 | Rf6896 | F | 1.6 | 158.00 | 181.06 | 204.18 |
| 14.59 | 29.23 |
Sighting Study II & 2000 | Rf6897 | F | 1.6 | 155.78 | 175.10 | 193.02 |
| 12.40 | 23.91 |
Main Study & 2000 | Rf6898 | F | 1.6 | 157.02 | 170.15 | 192.09 |
| 8.36 | 22.33 |
Rf6899 | F | 1.6 | 163.99 | 184.98 | 201.74 |
| 12.80 | 23.02 | |
Rf6900 | F | 1.6 | 160.18 | 178.86 | 205.15 |
| 11.66 | 28.07 | |
Rf6901 | F | 1.6 | 156.87 | 175.35 | 198.83 |
| 11.78 | 26.75 | |
|
|
| Mean | 159.52 | 177.34 | 199.45 |
| 11.15 | 25.04 |
|
|
| ±SD | 3.35 | 6.23 | 5.55 |
| 1.93 | 2.80 |
F: Female; SD: Standard Deviation
TABLE 3. INDIVIDUAL ANIMAL GROSS PATHOLOGY FINDINGS
Study Steps & Dose (mg/kg body weight) | Animal No. | Sex | Fate | Gross Pathology Findings | |
External | Internal | ||||
Sighting Study I & 300 | Rf6896 | F | TS | NAD | NAD |
Sighting Study II & 2000 | Rf6897 | F | TS | NAD | NAD |
Main Study & 2000 | Rf6898 | F | TS | NAD | NAD |
Rf6899 | F | TS | NAD | NAD | |
Rf6900 | F | TS | NAD | NAD | |
Rf6901 | F | TS | NAD | NAD |
NAD: No Abnormality Detected; F: Female; TS: Terminal Sacrifice
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Based on the results of the experiment, it is concluded that the LD50 value for the test item Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes steam distillation condensate (EC 942-492-8) is >2000 mg/kg body weight when administered as a single dose by oral gavage to female Sprague Dawley rat as per OECD Guidelines for Testing of Chemicals No. 420 (Section 4: Health Effects) on conduct of “Acute Oral Toxicity - Fixed Dose Method”. The substance is unclassified as per CLP regulation.
- Executive summary:
The test item Thermal cracking oil from blends of rubber, fuel oils and paraffin waxes steam distillation condensate (EC 942-492-8) was evaluated for acute oral toxicity in Sprague Dawley rats according to the OECD TG 420. The study was GLP compliant.
A starting dose of 300 mg/kg body weight was selected from the fixed dose levels of 5, 50, 300 and 2000 mg/kg body weight because of unavailability of sufficient toxicological data on the test item.
A total of 6 females were used for the experiment. All the animals of Sighting Study I, Sighting Study II and Main Study were administered with 300 mg/kg, 2000 mg/kg and 2000 mg/kg body weight respectively of the test item through oral route.No clinical signs of toxicity and mortalities were observed in any of the dosed animals.
No changes were observed in body weight and percent change in body weight with respect to day 1. All the animals revealed physiologically normal increase in the body weight.
No gross pathological changes were observed in any of the dosed animals.Based on the results of the experiment, it is concluded that the LD50 value for the test item is >2000 mg/kg body weight via the oral route, therefore, the substance is not classified as acutely toxic according to CLP criteria (Regulation
(EC) No 1272/2008).
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