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EC number: 248-597-9 | CAS number: 27676-62-6
- 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
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Carcinogenicity
Administrative data
Description of key information
Study not performed to any specified standard, however study data provided is clear and consice with reliable and plausible result.
NOAEL > 100 mg/kg (diet)
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- Not stated
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Study not performed to any noted standard or to GLP.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline followed
- GLP compliance:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Species/strain: Wistar rats
Sex: male/female
Rats were held in metal cages in a heated and ventilated environment. Animals were segregated by sex and had free access to feed. - Route of administration:
- oral: feed
- Vehicle:
- not specified
- Details on exposure:
- 100 mg/kg of powdered feed
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- No data
- Frequency of treatment:
- 24 months
- Post exposure period:
- No data
- Remarks:
- Doses / Concentrations:
100 mg/kg of powdered feed
Basis:
nominal in diet - No. of animals per sex per dose:
- No. of animals: 40 rats in total, 20 males and 20 females
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- Rats were held in metal cages in a heated and ventilated environment. Animals were segregated by sex and had free access to feed. All tissue specimens were stained with toluidene blue.
Six male animals died during the experiments and the other 14 animals were sacrificed at the end of the study. Three females were sacrificed for a preliminary report, one female died during the course of the experiment, and the remaining sixteen females were sacrificed at the end of the experiment. All of the autopsies performed on the animals were part of a complete histopathological study.
Reproduction evaluation:
Method: One male and five females from the 2-year carcinogenicity study were mated after seven months of treatment with 100 ppm of the test material. Their offspring (25 males and 27 females, first generation) were normal. Out of these 52 offspring of the first generation, 5 males and 5 females were treated with the test substance. These first generation rats were mated six months later to obtain a second generation. Their offspring (26 males and 22 females, second generation) were all normal. Of the 48 animals (second generation), 5 males and 5 females underwent treatment. - Positive control:
- No data
- Observations and examinations performed and frequency:
- No data
- Sacrifice and pathology:
- All of the autopsies performed on the animals were part of a complete histopathological study.
- Other examinations:
- No data
- Statistics:
- No data
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- Six male animals died during the experiments and the other 14 animals were sacrificed at the end of the study. Three females were sacrificed for a preliminary report, one female died during the course of the experiment, and the remaining sixteen females were sacrificed at the end of the experiment. All of the autopsies performed on the animals were part of a complete histopathological study.
Body weights and gross analysis did not show differences between control and treated rats.
Histological studies related to lungs, liver, spleen, pancreas, stomach, caecum, sigmoid and rectum, salivary glands, kidneys, uterus, ovaries, thyroid, thymus, lymphatic ganglions, heart and bone marrow revealed no abnormal developments.
No cardiac lesions were found.
Pulmonary Mycoplasmosis: A chronic mycoplasmic brancho-pneumopathy was seen in three of the animals and a chronic beginning bronchopneumonia on mycoplasmosis was seen in three of the animals. These pulmonary afflictions were also seen in the control animals.
Suppurative Otitis: A suppurative otitis without basilar abscess was seen in three animals. Meningeal diencephalons reactions were found in one animal which had suppurative otitis with basilar abcess. Similar findings were also seen in the control animals.
Digestive Tract: No lesions of the oesophagus or phrynx present. Intestinal valvulus observed.
Liver: Hepatic teatosis, hepatic inflammatory infiltration was found in two rats. Such hepatic afflictions are common in the control animals.
Spleen, Thymus, Lymphatic Ganglions: Spleen lymphoid hypertrophy, and splenitis was found in three rats. Similar spleen conditions were found in the control animals. No thymic lesions present. Mesentric cyst found in some rats. Similar findings occurred in the control animals.
Urinary Organs: Cystic nephrosis was found in three treated rats. Nephritis found in one rat. Similar conditions observed in the control animals.
Endocrine Glands: Cortico-suprarenal hypertrophy in 5 rats and hyperplasia on the hypophysis principal cells in 2 rats. Similar findings in control animals.
Male and Female Genital Organs: Testicular aplasia and epididymis inflammatory testicular infiltration found in a treated male rat. Similar findings occurred in control group. Hydrosalpinx, pyometra, congested uterus, benign ovarian cysts, benign mammary adenofibroid, atrophic genital tract and salient follicles were found in various treated females. Such findings were also found on the control females.
Reproduction evaluation: No teratogenic or congenital malformations are seen. All newborn animals from the second generation were carefully examined macroscopically. Autopsy was done on 10 animals of the first and second generation each. Neither the macropathological examination of the whole body nor the histopathology (lung, liver, spleen and kidney) showed any deviation from the normal morphology. There were no anomalies present in cranial-cerebral, digestive, thorax-visceral, abdnormal and genital studies. - Relevance of carcinogenic effects / potential:
- Treatment with the test substance did not cause malignant tumours in wistar rats.
- Dose descriptor:
- other: Negative
- Effect level:
- > 100 mg/kg diet
- Sex:
- male/female
- Basis for effect level:
- other: Treatment with the test substance did not cause malignant tumours in wistar rats.
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
- Conclusions:
- Treatment with the test substance did not cause malignant tumours in wistar rats.
- Executive summary:
Study not conducted to any noted standards or in compliance with the Principles of Good Laboratory Practice (GLP).
Reproduction evaluation:
Method: One male and five females from the 2-year carcinogenicity study were mated after seven months of treatment with 100 ppm of the test material. Their offspring (25 males and 27 females, first generation) were normal. Out of these 52 offspring of the first generation, 5 males and 5 females were treated with the test substance. These first generation rats were mated six months later to obtain a second generation. Their offspring (26 males and 22 females, second generation) were all normal. Of the 48 animals (second generation), 5 males and 5 females underwent treatment.
Six male animals died during the experiments and the other 14 animals were sacrificed at the end of the study. Three females were sacrificed for a preliminary report, one female died during the course of the experiment, and the remaining sixteen females were sacrificed at the end of the experiment. All of the autopsies performed on the animals were part of a complete histopathological study.
Body weights and gross analysis did not show differences between control and treated rats.
Histological studies related to lungs, liver, spleen, pancreas, stomach, caecum, sigmoid and rectum, salivary glands, kidneys, uterus, ovaries, thyroid, thymus, lymphatic ganglions, heart and bone marrow revealed no abnormal developments.
No cardiac lesions were found.
Pulmonary Mycoplasmosis: A chronic mycoplasmic brancho-pneumopathy was seen in three of the animals and a chronic beginning bronchopneumonia on mycoplasmosis was seen in three of the animals. These pulmonary afflictions were also seen in the control animals.
Suppurative Otitis: A suppurative otitis without basilar abscess was seen in three animals. Meningeal diencephalons reactions were found in one animal which had suppurative otitis with basilar abcess. Similar findings were also seen in the control animals.
Digestive Tract: No lesions of the oesophagus or phrynx present. Intestinal valvulus observed.
Liver: Hepatic teatosis, hepatic inflammatory infiltration was found in two rats. Such hepatic afflictions are common in the control animals.
Spleen, Thymus, Lymphatic Ganglions: Spleen lymphoid hypertrophy, and splenitis was found in three rats. Similar spleen conditions were found in the control animals. No thymic lesions present. Mesentric cyst found in some rats. Similar findings occurred in the control animals.
Urinary Organs: Cystic nephrosis was found in three treated rats. Nephritis found in one rat. Similar conditions observed in the control animals.
Endocrine Glands: Cortico-suprarenal hypertrophy in 5 rats and hyperplasia on the hypophysis principal cells in 2 rats. Similar findings in control animals.
Male and Female Genital Organs: Testicular aplasia and epididymis inflammatory testicular infiltration found in a treated male rat. Similar findings occurred in control group. Hydrosalpinx, pyometra, congested uterus, benign ovarian cysts, benign mammary adenofibroid, atrophic genital tract and salient follicles were found in various treated females. Such findings were also found on the control females.
Reproduction evaluation: No teratogenic or congenital malformations are seen. All newborn animals from the second generation were carefully examined macroscopically. Autopsy was done on 10 animals of the first and second generation each. Neither the macropathological examination of the whole body nor the histopathology (lung, liver, spleen and kidney) showed any deviation from the normal morphology. There were no anomalies present in cranial-cerebral, digestive, thorax-visceral, abdnormal and genital studies.
Conclusion: Treatment with the test substance did not cause malignant tumours in wistar rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the data available the substance does not trigger any of the requirements for classification.
The registered substance is therefore not classified.
Additional information
Study not performed to any specified standard, however study data provided is clear and concise with reliable and plausible result.
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.
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