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EC number: 225-443-9 | CAS number: 4851-50-7
- 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
Acute oral toxicity study: LD50 greater than 15000 mg/kg bw (discriminating dose) (OECD 401, K, Rel.2)
No studies available for acute inhalation or dermal toxicity.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- The test substance was dissolved in peanut oil at room temperature. It was then administered intragastrically to 10 female animals each of the doses 10000 and 15000 mg/kg respectively by means of a rigid metal gavage. The animals were inspected several times on the day of administration, and twice daily during the following 14-day observation period (once on weekends and bank holidays). During inspections the type, onset, duration, and intensity of clinical signs were recorded and dead animals were removed. The time of death of the deceased animals was documented.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- Designation: Macrolex Green G
Physical state: solid
Appearance: green powder - Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Experimental Animais
The acute toxicity experiment was carried out with young-adult SPF-bred female Wistar rats (Strain TNO/W70 (SPF Cpb).
The rat is the preferred species for investigating acute oral toxicity in mammals. At the start of the experiment, the rats were about 8 weeks of age.
The average initial weight of the female animals was 130 g. 10 rats were used per dose.
Housing Conditions
The rats were housed in groups of 5 under conventional conditions in Makrolon® Type-III cages on low-dust wood granules at a room temperature of 22 ± 2 °C, with humidity of about 50 ± 10%.
Nutrition
The animals received standard diet and tap water a libitum. - Route of administration:
- oral: gavage
- Vehicle:
- peanut oil
- Details on oral exposure:
- The test substance was dissolved in peanut oil at room temperature. It was then administered intragastrically to 10 female animals each of the doses 10000 and 15000 mg/kg respectively by means of a rigid metal gavage on a constant application volume of 30 ml/kg body weight.
- Doses:
- 10000 or 15000 mg/kg bw.
- No. of animals per sex per dose:
- 10 female animals/dose.
- Control animals:
- no
- Details on study design:
- The animals were inspected several times on the day of administration, and twice daily during the following 14-day observation period (once on weekends and bank holidays). During inspections the type, onset, duration, and intensity of clinical signs were recorded and an dead animals were removed. The time of death of the deceased animals was documented. The animals were weighed individually directly before administration and groupwise after one week and at the end of the observation.
- Key result
- Sex:
- female
- Dose descriptor:
- discriminating dose
- Effect level:
- 15 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animals died during the 14-day observation period.
- Clinical signs:
- other: other: After single administration of 10000 and 15000 mg/kg MACROLEX Green G all rats had a rough coat. There were no other signs of intoxication.
- Gross pathology:
- Not examined.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 was greater than 15000 mg/kg bw (discriminating dose).
- Executive summary:
A single dose of 10000 or 15000 mg/kg bw of the test substance was applied to 10 female Wistar rats each per gavage. The animals were inspected several times on the day of administration, and twice daily during the following 14-day observation period. After the single administration of 10000 and 15000 mg/kg MACROLEX Green G all rats had a rough coat. There were no other signs of intoxication. No animals died during the 14-day observation period. The LD50 was greater than 15000 mg/kg bw (discriminating dose).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 15 000 mg/kg bw
- Quality of whole database:
- Equivalent or similar to OECD guideline 401.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
According to REACH Regulation (EC) No 1907/2006 Annex VIII, 8.5.3 Column 2:
Testing by the dermal route does not need to be conducted if:
— the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and
— no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation) or, in the absence of an in vivo study by the oral route, no systemic effects after dermal exposure are predicted on the basis of non-testing approaches (e.g. read across, QSAR studies).
The registered substance conforms with the requirements given above. Therefore, it can be concluded for acute dermal toxicity that the available information is conclusive for non-classification. - Clinical signs:
- other: other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
The acute oral toxicity is greater than 15000 mg/kg bw (discriminating dose).
According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.
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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