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Diss Factsheets
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EC number: 940-422-0 | 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
Endpoint summary
Administrative data
Description of key information
With regard to the acute toxicity of the registered substance, key studies for the oral and dermal exposure route are available. Using the acute toxic class method according OECD test TG 423, the LD50 cut-off value of Glucamide CC is 2500 mg/kg body weight. Intoxicated animals showed a consistent clinical picture pointing to an unspecific mode of action. The acute dermal toxicity of the registered substance was evaluated in an OECD 402 study according to GLP. After topical treatment with the limit dose of 2000 mg/kg body weight neither mortality nor significant clinical symptoms of intoxication were observed. The LD50 after dermal treatment was established to be greater 2000 mg/kg body weight.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 500 mg/kg bw
- Quality of whole database:
- Data reliable and meet criteria for classification & labelling requirements.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Acute studies with Glucamide CC have revealed a low toxicity for all routes of exposure. Using the acute toxic class method according OECD test guideline 423, Glucamide CC exhibits low acute oral toxicity (CLP no category). The LD50 cut-off value following single oral application of Glucamide CC to rats via gavage is 2500 mg/kg body weight. Intoxicated animals showed a consistent clinical picture (e.g. reduced spontaneous activity, piloerection, prone or hunched position) pointing to an unspecific mode of action. All symptoms recovered within up to 3 days post-dose.Throughout the 14-day observation period, the weight gain of the surviving animals was within the normal range of variation for this strain.
Data regarding acute oral toxicity are also available on the read-across compound Glucamide 24 (Test material E-4086.01, 45% active).In an OECD TG 401 (1987 study, Wistar rats were exposed via oral gavage to 900 mg a.i./kg bw (2000 mg test article/kg bw) or 2000 mg a.i./kg bw (4444 mg test article/kg bw). No deaths occurred in the study. Weight loss was observed in one female at the high dose on Days 8 – 15 and body weight gain was reduced in 2 high-dose and 1 low-dose females.At the lower dose, signs were observed in a few male rats which included slight sedation and slight ruffled fur; in the high dose group, slightly ruffled fur was observed in two animals of each sex. The acute oral LD50 was concluded to be greater than 2000 mg Glucamide/kg body weight
With regard to acute systemic dermal toxicity, single administration of 2000 mg/kg body weight to rats according OECD test guideline 402 was not associated with mortality or with any clinical signs of toxicity. However, reversible signs of dermal irritation were observed at the treated skin sites. The LD50 of Glucamide CC in rats is thus greater 2000 mg/kg body weight.The read-across compound, Glucamide 24 (Test material, E-4194.01, 98.8%, also has low acute toxicity via the dermal route and thus support a.m. conclusion. Testing in male and female New Zealand White rabbits using EEC Methods Directive 84/449/EEC, Part B, Method B3 (1984) indicated a comparable LD50 of greater 2000 mg/kg body weight.
Justification for selection of acute toxicity – oral endpoint
Guideline study according to GLP. No derivations and/or confounders. Klimisch rating 1 representing reliability without restrictions. Information is valid and meet data requirements.
Justification for selection of acute toxicity – dermal endpoint
Guideline study according to GLP. No derivations and/or confounders. Klimisch rating 1 representing reliability without restrictions. Information is valid and meet data requirements.
Justification for classification or non-classification
Based on the results from an OECD TG 423 guideline study which revealed a LD50 cut-off value of 2500 mg/kg body weight, no classification according to CLP of Glucamide CC is warranted with regard to acute oral toxicity.
Based on the results from an OECD 402 guideline study which revealed a LD50 greater 2000 mg/kg body weight, no classification of Glucamide CC according to CLP is warranted with regard to acute dermal toxicity.
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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