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EC number: 942-177-5 | 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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2021
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Plastic, waste, pyrolized, fractionation bottoms
- EC Number:
- 942-177-5
- Molecular formula:
- Not available, UVCB substance
- IUPAC Name:
- Plastic, waste, pyrolized, fractionation bottoms
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Dose / conc.:
- 250 mg/kg bw/day
- Dose / conc.:
- 500 mg/kg bw/day
- Dose / conc.:
- 1 000 mg/kg bw/day
- No. of animals per sex per dose:
- Group1-Control: 12 males, 12 females
Group 2-Low dose: 12 males, 12 females
Group 3-Intermediate dose: 12 males, 12 females
Group 4 - High dose: 12 males, 12 females
Group 1S - Control: 5 males, 5 females
Group 4S - High dose: 5 males, 5 females
Total number of animals received 128 (64 males and 64 females )
Total number of animals used 116 (58 males and 58 females)
(Females were nulliparous and non-pregnant) - Control animals:
- yes
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Description (incidence and severity):
- No treatment-related effects were detected on mating performance. All the female animals of control, low, intermediate and high dose groups showed positive evidence of mating. No significant difference was observed in the pre-coital interval of female animals between control, low, intermediate and high dose group.
Oestrous cyclicity was checked for all the female animals. Regular oestrous cycle was observed in all the animals of different groups in the study - Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- Mating index for all the groups was 100 % (as confirmed by presence of sperm in the vaginal smear).
The two Dam each from control (G1- 0 mg/kg body weight) and high dose (1000 mg/kg/day) and one Dam each from low (G2- 250 mg/kg body weight) and intermediate (G3-500 mg/kg body weight) groups was observed non pregnat.
The pregnancy index for control (G1- 0 mg/kg body weight), low (G2-250 mg/kg body weight), intermediate (G3-500 mg/kg body weight) and high (G4-1000 mg/kg body weight) was found to be 83.3, 91.7, 91.7 and 83.3, respectively.
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reproductive function (oestrous cycle)
- reproductive function (sperm measures)
- reproductive performance
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No significance changes were observed in post natal losses in the entire treated group in both the sexes.
Of the litters delivered, in all the treatment groups, litter size at birth and subsequently on Day 1 and 4 post-partum were comparable to controls. No significant difference in the live birth was noted between control and treated groups. No nipple retention was found in any of the male litter from vehicle control, low, intermediate and high dose groups. - Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Offspring body weight on day 1, day 4 and 13 were recorded. No significant differences observed in body weight on day 1 and day 13 was observed in low dose group (G2- 250 mg/kg body weight), intermediate (G3- 500 mg/kg body weight) and high dose group (G4- 1000 mg/kg body weight) when compared with control (G1- 0 mg/kg body weight) group.
- Sexual maturation:
- not examined
- Anogenital distance (AGD):
- no effects observed
- Description (incidence and severity):
- Offspring body weight on day 1, 4 and 13 were recorded. Significant change was observed on day 1 of intermediate (G3-500 mg/kg body weight) and high dose (G4-1000 mg/kg body weight) revealed decreased and increased respectively in both the sexes. Decreased significance observed on day 4 and 13 in low dose (G2-250 mg/kg body weight) and intermediate dose (G3-500 mg/kg body weight) in both the sexes when compared with vehicle control group) and could not be attributed to test item administration and no any biological evidant.
No significant differences in the anogenital distances (AGD) between control (G1- 0 mg/kg body weight and treated animals in low (G2- 250 mg/kg body weight), intermediate (G3- 500 mg/kg body weight) and high (G4- 1000 mg/kg body weight dose group of animals.
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- > 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- The administration of TACOIL to Wistar rats by oral gavage, at dose levels of 0, 250, 500 and 1000 mg/kg/day, resulted no treatment-related clinical signs in high dose group, changes in the body weights, feed consumption in high dose group. No treatment-related effects on reproduction/ development such as mating index, fertility index, gestation length, post-natal loss, sex ratio and offspring growth and development.
Macroscopic examination revealed no test item related findings in any of the animals of 250, 500 and 1000 mg/kg as well as in high dose satellite group treated at 1000 mg/kg. No abnormality was observed attributable to test item in pups from all treatment groups.
Microscopic examination revealed no abnormality attributable to test item TACOIL at the highest dose tested i.e. 1000 mg/kg body weight.
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