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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
Skin Irritation - Molyvan 855 is slightly irritating under the conditions of this study.
Eye Irritation - Molyvan 855 was found to be moderately irritating.
Respriratory Irritation - study not required
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted similar to OECD Guideline under GLP conditions. Study report does not specifically identify test guideline followed, however, evaluation of the full study supports that the study is conducted similar to OECD test guidelines.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
Approved supplier
- Age at study initiation:
Young adult
- Weight at study initiation:
2.40 +/- 0.14 KG
- Housing:
All housing and care conformed to the standards established in "Guide for the care and Use of Laboratory Animals" DHEW Publications No. (NIH) 85-23.
- Diet (e.g. ad libitum):
Certified rabbit feed ad libitum
- Water (e.g. ad libitum):
Tap water ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
Room temperature
- Photoperiod (hrs dark / hrs light):
12 Hour light dark cycle maintained. - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 4.5, 28, 52 and 76 hours post-exposure
4, 7, 10 and 14 days post exposure - Number of animals:
- 6
- Details on study design:
- On the day prior to dosing, the back of each rabbit was clipped free of fur with electric clippers. During this procedure, care was taken to avoide accidental abrasion to the skin. On the day of dosing. a volume of 0.5 ml of the test article was applied to each of 2 test sites. Following application, each test site was occluded with a one-inch square gauze patch held in place with Blenderm(r) tape.
Four hours post-dose, the patches were removed. The exposure sites were gently wiped with clean gauze to remove as much non-absorbed test article as possible. One half hour after unwrapping, the exposure sites were examined and scored separately for both erythema and edema on a graded sc all of 0 to 4 in accordance with the Skin Reaction Code. The exposure sites were again examined and scored at 28, 52 and 76 hours post-dose. Any signs of irritation were noted and observations were made on day 4, 7, 10 and 14 or until all sites returned to normal. Any extraordinary finding. dermal or toxicological, were noted.
In evaluation the average irritation, scores for individual intact exposure sites were recorded separately for each of the scoring time intervals. Based on the 28, 52 and 76 hour observations, a total for erythema and eschar formation was added to a total for edema, then divided by 6 to yield individual animal score. The mean of the six scores was calculated and this score represents the mean primary score. - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 76 hours post dosing
- Score:
- 0.73
- Max. score:
- 8
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- other: 76 hours post dosing
- Score:
- 1
- Max. score:
- 8
- Irritation parameter:
- overall irritation score
- Basis:
- animal #2
- Time point:
- other: 72 hours post dosing
- Score:
- 1.2
- Max. score:
- 8
- Irritation parameter:
- overall irritation score
- Basis:
- animal #3
- Time point:
- other: 72 hours post dosing
- Score:
- 0.83
- Max. score:
- 8
- Irritation parameter:
- overall irritation score
- Basis:
- animal #4
- Time point:
- other: 72 hours post dosing
- Score:
- 0.67
- Max. score:
- 8
- Irritation parameter:
- overall irritation score
- Basis:
- animal #5
- Time point:
- other: 72 hours post dosing
- Score:
- 0.33
- Max. score:
- 8
- Irritation parameter:
- overall irritation score
- Basis:
- animal #6
- Time point:
- other: 72 hours post dosing
- Score:
- 0.33
- Max. score:
- 8
- Irritant / corrosive response data:
- Slight erythema and eschar formation was the primary effect observed in animals up until 76 hours post dosing. Slight edema formation was observed in two animals post dosing up to 28 hours post dosing.
- Other effects:
- One animal died on day 8 and another on day 14. Prior to death of the above two animals, anorexia and diarrhea were observed. No lesions or abnormalities were noted in these animals at gross necropsy.
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Modification of J. Soc. Cosmet. Chem. Vol 13, No 6. 1962, p. 281 - 289
- Conclusions:
- Molyvan 855 is slightly irritating under the conditions of this study.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted similar to OECD Guideline under GLP conditions. Study report does not specifically identify test guideline followed, however, evaluation of the full study supports that the study is conducted similar to OECD test guidelines.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Principles of method if other than guideline:
- Principles and Procedures for Evaluating the Toxicity of Household Substances.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- undiluted 0.1 ml
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml undiluted
- Duration of treatment / exposure:
- one time administration
- Observation period (in vivo):
- 1, 24, 48 and 72 hours and again at 4 and 7 days
- Number of animals or in vitro replicates:
- 9 total
6 unwashed (test material only)
3 (test material washed 30 seconds after application with luke warm water) - Details on study design:
- 9 New Zealand White rabbits were administered 0.1 ml of the test substance in one eye of each rabbit. For six rabbits the treated eye remained unwashed and for the remaining 3 rabbits, the eye was washed 30 seconds post exposure with luke warm water. The other eye of each rabbit served as the control.
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- other: overall
- Time point:
- other: 72 hours
- Score:
- 45
- Max. score:
- 110
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 hr
- Score:
- 6.7
- Remarks on result:
- other: + or - 1.6 (no washout)
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 hrs
- Score:
- 2.3
- Remarks on result:
- other: + or - 1.5 (no washout)
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0.3
- Remarks on result:
- other: + or - 0.8 (no washout)
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: (no washout)
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 hr
- Score:
- 4
- Remarks on result:
- other: + or - 2.0 (30 second washout)
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 2
- Remarks on result:
- other: + or - 2.0 (30 second washout)
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: (30 second washout)
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: (30 second washout)
- Irritant / corrosive response data:
- The study report/author did not provide the MMTS, this was calculated based upon the results provided within the study report. All effects noted were fully reversible within 72 hours with only minor effect still being documented in one animal at 48 hours post treatment
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: study author
- Conclusions:
- Molyvan 855 was found to be moderately irritating.
Reference
No observations are noted as being made on days 4 and 7.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Skin Irritation:
Key study
In a GLP study similar to OECD 404, New Zealand White Rabbits exposed to Molyvan 855 slight erythema and eshcar formation was the primary effect observed in animals up until 76 hours post dosing. Slight edema formation was observed in two animals post dosing up to 28 hours post dosing (Food and Drug Research Laboratories, Inc, 1985).
Eye Irritation:
Key study
In a GLP study similar to OECD 405, using New Zealand White rabbits, all effects noted were fully reversible within 72 hours with only minor effect still being documented in one animal at 48 hours post treatment, Molyvan 885 was found to be moderately irritating (Food and Drug Research Laboratories, Inc, 1985).
Justification for selection of skin irritation / corrosion endpoint:
Well conducted study similar to OECD 404 under GLP conditions.
Justification for selection of eye irritation endpoint:
Well conducted study similar to OECD 405 under GLP conditions.
Effects on skin irritation/corrosion: slightly irritating
Effects on eye irritation: moderately irritating
Justification for classification or non-classification
Skin irritation:
In the key study conducted similar to OECD 404 under GLP conditions, slight erythema and eshcar formation was the primary effect observed in animals up until 76 hours post dosing; slight edema formation was observed in two animals post dosing up to 28 hours post dosing (Food and Drug Research Laboratories, Inc, 1985) therefore, according to Regulation EC No. 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures, Molyvan 855 is not classified for skin irritation/corrosion.
Eye irritation
In the key study conducted similar to OECD 405 under GLP conditions, all effects noted were fully reversible within 72 hours with only minor effects still being documented in one animal at 48 hours post treatment, (Food and Drug Research Laboratories, Inc, 1985).
Therefore, according to Regulation EC No. 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures, Molyvan 855 is not classified for eye irritation.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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