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EC number: 204-807-0 | CAS number: 126-83-0
- 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
Description of key information
Oral: OECD 422, rat. Reproductive NOEL: 1000 mg/kg/day (highest dose tested). Reliability = 1.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- 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 potential toxic effects of the test substance were evaluated when administered to rats for 28 days and to evaluate the potential of the test substance to affect male and female reproductive performance such as gonadal function, mating behavior, and conception through Day 13 of postnatal life. The test substance in the vehicle (0.5% carboxymethylcellulose and 0.1% Tween® 80 in deionized water, pH 3.5) was administered orally by gavage once daily to 3 groups of Crl:CD(SD) rats, each group consisting of 10 males and 10 females. Dosage levels were 250, 500, and 1000 mg/kg/day. A concurrent control group of 10 rats/sex received the vehicle on a comparable regimen. Mean body weights, body weight gains, and food consumption for F0 males and females at 250, 500, and 1000 mg/kg/day were unaffected by test substance administration throughout the study. F0 estrous cycle length, reproductive performance (mating, fertility, and copulation/conception indices), gestation length, and parturition were unaffected by test substance administration. No test substance-related effects were noted during the FOB or motor activity evaluations at any dosage level in the F0 generation. There were no test substance-related effects on the mean number of implantation sites and unaccounted-for sites in the 250, 500, and 1000 mg/kg/day groups. There were no test substance-related macroscopic or microscopic findings, or effects on clinical pathology parameters and organ weights noted for F0 males and females at any dosage level. There were no test substance-related effects on thyroid hormone values noted for F0 males or F1 pups on PND 13 at any dosage level. There were no test substance-related effects on the number of F1 pups born, live litter size, percentage of males at birth, F1 clinical observations, postnatal survival and growth, anogenital distance, or areolae/nipple anlagen. There were no test substance-related macroscopic findings for F1 pups that were found dead or at the PND 13 scheduled necropsy at any dosage level. There were no test substance-related changes in thyroid/parathyroid weights in F1 males and females on PND 13. Under the conditions of this screening study, no test substance-related effects were noted at any dosage level. Therefore, a dosage level of 1000 mg/kg/day, the highest dosage level evaluated, was considered to be the no-observed-effect level (NOEL) for F0 reproductive toxicity, F0 parental systemic toxicity, and F1 neonatal toxicity of the test substance when administered orally by gavage to Crl:CD(SD) rats.
Effects on developmental toxicity
Description of key information
Oral: NOAEL; OECD 422, rat. NOEL for developmental toxicity was 1000 mg/kg/day (highest dose tested). Reliability = 1.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Study duration:
- subacute
- Species:
- rat
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 objectives of the study were to evaluate the potential toxic effects of the test substance, when administered to rats for 28 days. The test substance, in the vehicle (0.5% carboxymethylcellulose and 0.1% Tween® 80 in deionized water, pH 3.5) was administered orally by gavage once daily to 3 groups of Crl:CD(SD) rats, each group consisting of 10 males and 10 females. Dosage levels were 250, 500, and 1000 mg/kg/day. A concurrent control group of 10 rats/sex received the vehicle on a comparable regimen. Males received a total of 28–29 doses and females received a total of 52 doses. All animals were observed for mortality and morbundity. Clinical observations, body weight, and food consumption, FOB and motor activity data, clinical pathology, macroscopic and microscopic (control and high dose only) examinations were performed. All F0 males and females in the 250, 500, and 1000 mg/kg/day groups survived to the scheduled necropsies. Two F0 females in the control group were found dead or euthanized in extremis during the study. No test substance-related clinical observations were noted at the daily examinations, detailed physical observations, or approximately 2 hours following dose administration at any dosage level. Mean body weights, body weight gains, and food consumption for F0 males and females at 250, 500, and 1000 mg/kg/day were unaffected by test substance administration throughout the study. No test substance-related effects were noted during the FOB or motor activity evaluations at any dosage level in the F0 generation. There were no test substance-related macroscopic or microscopic findings, or effects on clinical pathology parameters (haematology, coagulation, serum chemistry) and organ weights noted for F0 males and females at any dosage level. There were no test substance-related effects on thyroid hormone values noted for F0 males at any dosage level. Under the conditions of this screening study, no test substance-related effects were noted at any dosage level. Therefore, a dosage level of 1000 mg/kg/day, the highest dosage level evaluated, was considered to be the no-observed-effect level (NOEL) F0 parental systemic toxicity, of the test substance when administered orally by gavage to Crl:CD(SD) rats.
Justification for classification or non-classification
Based on a NOEL of 1000 mg/kg (highest dose tested) in an OECD 422 repeated dose/reproductive/developmental screening study, the substance does not need to be classified for reproductive or developmental toxicity according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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.
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