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Diss Factsheets
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EC number: 272-032-5 | CAS number: 68649-48-9
- 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
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
The reproductive toxicity of the test material was determined in a combined repeated dose toxicity study with the reproduction / developmental toxicity screening test, performed according to OECD guideline 422.
Sprague-Dawley rats (10 per sex per dose) were given 54 consecutive doses of the test material, receiving 100, 300 or 1000 mg/kg/day. Both the adults and the F1 generation were observed during 54 day study and subjected to necropsy at termination. Examination of reproductive performance offspring litter sizes, sex ratios, reproductive and viability indices show that there is no evidence of reproductive toxicity in this study. One high dose female failed to achieve pregnancy and another female from this dose group was sacrificed at parturition due to dystocia. These are normal low incidental findings observed on reproductive studies and considered unrelated to treatment.
No treatment related effects were detected in reproduction, therefore the ‘No Observed Adverse Effect Level’ (NOAEL) for reproductive toxicity was considered to be 1000 mg/kg/day.
The study was performed in line with GLP and an accepted standardised guideline with a high standard of reporting. However, the study was performed with a structural analogue and so was assigned a reliability score of 2 in accordance with the criteria for assessing data quality as outlined in Klimisch (1997) and considered suitable for assessment as an accurate reflection of the test material.
The results of this read-across study can be considered to represent a worst case since the test material (Distillates (petroleum), oxidized light) is a shorter chain material and therefore has a greater potential for absorption within the body. The read-across substance can therefore be considered to be potentially more bioavailable than the registered substance, which, due to its very high log Pow value, is anticipated to have only very limited potential for bioavailability.
In accordance with Column 2 (adaptation statement) of Annex IX of Regulation (EC) 1907/2006 (REACH), it is considered justified to omit the two-generation reproductive toxicity study required under information point 8.7.3 if the substance is of low toxicological concern. The toxicological activity of the substance is negligible and the toxicokinetic assessment of the registered substance shows low potential for absorption.
Short description of key
information:
NOAEL = 1000 mg/kg bw/day, male/female rat, OECD 422, Dhinsa (2005)
Justification for selection of Effect on fertility via oral route:
The oral route was considered the most appropriate route. Only one
study was available.
The study was performed in line with GLP and an accepted standardised
guideline with a high standard of reporting. The study was performed
with a structural analogue and so was assigned a reliability score of 2
in accordance with the criteria for assessing data quality as outlined
in Klimisch (1997) and considered suitable for assessment as an accurate
reflection of the test material.
Effects on developmental toxicity
Description of key information
NOAEL = 1000 mg/kg bw/day, male/female rat, OECD 422, Dhinsa (2005)
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
The developmental toxicity of the test material was determined in a combined repeated dose toxicity study with the reproduction / developmental toxicity screening test, performed according to OECD guideline 422.
Sprague-Dawley rats (10 per sex per dose) were given 54 consecutive doses of the test material, receiving 100, 300 or 1000 mg/kg/day. Both the adult and the F1 generation were observed during 54 day study and subjected to necropsy at termination. All animals, including those dying during the study, were subjected to a full external and internal examination post parturition, and any macroscopic abnormalities were recorded.
No adverse effects or systemic signs of toxicity were recorded as a result of treatment during this study. One high dose female failed to achieve pregnancy and another female from this dose group was sacrificed at parturition due to dystocia. These are normal low incidental findings observed on reproductive studies and considered unrelated to treatment. No treatment related effects were detected in offspring growth or development, therefore the ‘No Observed Adverse Effect Level’ (NOAEL) for developmental toxicity was considered to be 1000 mg/kg/day.
The study was performed in line with GLP and an accepted standardised guideline with a high standard of reporting. However, the study was performed with a structural analogue and so was assigned a reliability score of 2 in accordance with the criteria for assessing data quality as outlined in Klimisch (1997) and considered suitable for assessment as an accurate reflection of the test material.
The results of this read-across study can be considered to represent a worst case since the test material (Distillates (petroleum), oxidized light) is a shorter chain material and therefore has a greater potential for absorption within the body. The read-across substance can therefore be considered to be potentially more bioavailable than the registered substance, which, due to its very high log Pow value, is anticipated to have only very limited potential for bioavailability.
In accordance with Column 2 (adaptation statement) of Annex IX of Regulation (EC) 1907/2006 (REACH), it is considered justified to omit the pre-natal toxicity study required under information point 8.7.3 if the substance is of low toxicological concern. The toxicological activity of the substance is negligible and the toxicokinetic assessment of the registered substance shows low potential for absorption.
Justification for selection of
Effect on developmental toxicity: via oral route:
The oral route was considered the most appropriate route. Only one
study was available.
The study was performed in line with GLP and an accepted standardised
guideline with a high standard of reporting. The study was performed
with a structural analogue and so was assigned a reliability score of 2
in accordance with the criteria for assessing data quality as outlined
in Klimisch (1997) and considered suitable for assessment as an accurate
reflection of the test material.
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation 1272/2008, the test material does not require classification as no signs of toxicity were noted during the course of the study.
Additional information
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.