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EC number: 430-380-7 | CAS number: 445409-27-8
- 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 Toxicity - Oral: Based on the results of this study, the acute lethal oral dose (LD50) of Molyvan 855 was estimated to be greater than 5 g/kg of body weight in male and female rats.
Acute Toxicity - Dermal: Based on the results of this study, the acute lethal dermal dose (LD50) of Molyvan 855 was estimated to be greater than 2.0 g/kg of body weight in New Zealand White Rabbits.
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted similar to OECD Guideline under GLP conditions.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Rats were obtained from Charles River Breeding Laboratories, Inc. Housing and Care conformed to the standards established in the "Guide for the Care and Use of Laboratory Animals" DHEW Publication No. (NIH) 85-23. Acclimation period of at least 5 days. Animals were fasted overnight prior to proceeding a single oral dose.
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Single oral dose by gavage
- Doses:
- 5.0 g/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- Similar to OECD TG 401. Single oral dose 5 male/5 female rats with 15-day post-administration observation period.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 other: g/kg
- Based on:
- test mat.
- Mortality:
- All animals survived the 15-day post observation period. No deaths occurred.
- Clinical signs:
- other: Effect Males Females Salivation 3/5 4/5 Diarrhea 1/5 2/5 Decreased activity 1/5
- Gross pathology:
- All animals were subject to gross necropsy. There were no noteworthy findings.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of this study, the acute lethal oral dose (LD50) of Molyvan 855 was estimated to be greater than 5 g/kg of body weight in male and female rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- 1
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted similar to OECD Guideline under GLP conditions.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 10 young adult NZ white rabbits were obtained from Ace Animals, Inc for use in this study. All housing and care conformed to the standards established in the "Guide for the Care and Use of Laboratory Animals" DHEW Publication No. (NIH) 85-23. All animals were acclimated for a minimum of at lead 5 days. During this acclimation period, the rabbits were examined with respect to their general health to assure their suitability as test animals.
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Duration of exposure:
- 24 hours
- Doses:
- 2.0 g/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- On the day prior to dosing, the back of each rabbit was clipped free of fur with electric clippers. The test article was administered to intact skin under an occlusive binder at a level of 2.0 g/kg bw. The binder consisted of a layer of plastic wrap and stockinette sleeve all securely held in place with masking tape. Animals were evaluated at the end of the 15-day post application observation period.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 other: g/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred
- Clinical signs:
- other: Observation Males Females Soft stools 3/5 0/5 Nasal discharge 1/5 0/5 Anorexia
- Gross pathology:
- No noteworthy findings.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of this study, the acute lethal dermal dose (LD50) of Molyvan 855 was estimated to be greater than 2.0 g/kg of body weight in New Zealand White Rabbits.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- 1
Additional information
Acute Toxicity - Oral route
Key study
In an OECD 401 study conducted according to GLP, using male and female SD rats, the oral LD50 of Molyvan 855 is greater than 5 g/kg of body weight (Food and Drug Research Laboratories, Inc, 1985).
Acute Toxicity - Inhalation route
Data Waiver
According to 8.5.2 Column 2 Annex VIII of Regulation (EC) 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), the acute toxicity, via inhalation route, of a substance does not need to be conducted if exposure of humans via inhalation is unlikely, taking into account the vapour pressure (for liquids) and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. Molyvan 855 has a vapour pressure of lss than 0.00042 kPa, thus human exposure is considered unlikely, therefore, this endpoint is waived.
Acute Toxicity - Dermal route
Key study
In an OECD 402 study conducted according to GLP, using male and female New Zealand White Rabbits, the dermal LD50 of Molyvan 855 is greater than 2.0 g/kg of body weight.
Justification for selection of acute toxicity – oral endpoint
Well conducted study similar to OECD Guideline 401 and GLP.
Justification for selection of acute toxicity – inhalation endpoint
According to 8.5.2 Column 2 Annex VIII of Regulation (EC) 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), the acute toxicity, via inhalation route, of a substance does not need to be conducted if exposure of humans via inhalation is unlikely, taking into account the vapour pressure (for liquids) and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. Molyvan 855 has a vapour pressure of lss than 0.00042 kPa, thus human exposure is considered unlikely, therefore, this endpoint is waived.
Justification for selection of acute toxicity – dermal endpoint
Well conducted study similar to OECD Guideline 402 and GLP.
Justification for classification or non-classification
Oral route:
The oral LD50 of Molyvan 855 is >5,000 mg/kg b.w., therefore, according to Regulation EC No. 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures, Table 3.1.1, Molyvan 855 is not classified for Acute Oral Toxicity.
Dermal route:
The dermal LD50 of Molyvan 855 is estimated to be >2 g/kg b.w., therefore, according to Regulation EC No. 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures, Table 3.1.1, Molyvan 855 is not classified for 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.
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.