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EC number: 208-795-8 | CAS number: 541-91-3
- 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: LD50 > 5000 mg/kg bw (in 2 studies; similar to OECD 401 in rats; rel.2, WoE)
Acute toxicity: dermal: LD50 > 5000 mg/kg bw/day (similar to OECD 402 in rabbits, rel.2, S)
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:
- weight of evidence
- Study period:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Basic data given: comparable to standard guideline OECD 401. No details on test item purity, form or batch number, on test animals, environmental conditions of animal room and body weight.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- No details on test animals, environmental conditions of animal room and body weight.
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No data
- Route of administration:
- oral: unspecified
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10 animals/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for toxicity and clinical signs daily for 14 days.
- Necropsy of survivors performed: Yes - Statistics:
- No data
- Preliminary study:
- Not applicable
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: No clinical signs were observed.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the oral LD50 for the test substance is higher than 5000 mg/kg bw in rats therefore it is not classified according to the Annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
- Executive summary:
In an acute oral toxicity study (limit test), performed similarly to OECD Guideline No. 401, groups of rats (10/dose) were administered a single oral dose of test material at 5000 mg/kg bw. Animals were then observed for mortality and clinical signs daily for 14 days.
No mortality or clinical signs were observed at 5000 mg/kg bw. No abnormalities were noted at necropsy.
Rat Oral LD50 = 5000 mg/kg bw
Under the test conditions, test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1997
- 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)
- Deviations:
- yes
- Remarks:
- no details of diet and water to test animals reported; No justification for solvent used.
- Principles of method if other than guideline:
- Test substance was orally administered to rats by gavage at dose level of 5000 mg/kg bw. The animals were observed for mortality, clinical signs and body weight for 14 days and then necropsied for macroscopic observations.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- - Source: Cho Seon Pharm. & Trading Co., Ltd.
- Physical state: Colourless liquid
- Impurities (identity and concentrations): no data
- Lot/batch No.: Pilot 3, 96.11.27
- Expiration date of the lot/batch: no data - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Japan
- Housing: 5 animals/sex were housed in polycarbonate cages
ENVIRONMENTAL CONDITIONS
- Temperature: 23 ± 3 °C
- Humidity: 50 ± 10%
- Photoperiod: 12 h light/12 h dark - Route of administration:
- oral: gavage
- Vehicle:
- other: 0.1% Tween 80 solution
- Details on oral exposure:
- DOSAGE PREPARATION
- The dose was calculated for each individual animal based on the body weight on the day of administration by using the ratio 0.9221/kg bw. For preparation of the test substance, the calculated amount of l-muscone was mixed with 0.1% Tween 80 solution to obtain a final concentration of 500 mg/mL, which was mixed completely with a stirrer and then gavaged to rats using a feeding needling.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Animals were monitored and recorded for any clinical signs every hour up to 6 h followed by additional checking in a day at fixed interval for 14 days. The observation was made on changes in general conditions, appearance of toxic symptoms, animal death, and symptoms that might appear to be caused by test substance administration.
- Frequency of weighing: Body weights of all animals were measured twice a week during the experimental period before administration of the test substance and at the time of autopsy.
- Necropsy of survivors performed: Yes; dead animals were immediately autopsied and subjected to macroscopic examination. All surviving animals were subjected to gross necropsy. - Statistics:
- Median lethal dose (LD50) values for the test material were calculated using the Litchfield and Wilcoxon method, and statistical analysis of data obtained from the main test including the body weight was performed to evaluate the significance of the difference between the control and treated groups using the Student’s t-test.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: No clinical signs were observed.
- Gross pathology:
- - No abnormalities were noted at necropsy.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the oral LD50 for the substance is higher than 5000 mg/kg bw in rats therefore it is not classified according to the Annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
- Executive summary:
In an acute oral toxicity study (limit test), a groups (5/sex/dose) of Sprague-Dawley rats were given a single oral (gavage) dose of test substance at 5000 mg/kg bw in 0.1% Tween 80 solution. A similar group of rats was administrated 0.1% Tween 80 solution. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination.
No mortality or clinical signs was observed. Test substance treated group showed a significant weight loss from the day of administration of test substance to autopsy day. However, females in this group showed a significant weight loss only during the first 2 days after administration of test substance and gradually recovered thereafter, resulting in no significant weight changes. No abnormalities were noted at necropsy of animals that were killed at the end of the study.
Oral LD50 Combined > 5000 mg/kg bw.
Under the test conditions, the test substance is not classified for acute oral toxicity according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.
Referenceopen allclose all
None
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- The two studies were non-GLP but were of good quality (Klimish score= 2)
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Not required for substances at the REACH Annex VII tonnage level.
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Basic data given: comparable to standard guideline. comparable to guideline study with acceptable restrictions Pre-guideline and pre-GLP study. Only basic data given, but considered sufficiently reliable for the purpose of hazard assessment.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- (no details on test animals, environmental condition of animal room, dermal exposure (duration, occlusive-dressing or not, abraded skin or not), body weight)
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No data
- Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg bw - Duration of exposure:
- No data
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10 animals/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for toxicity and clinical signs daily for 14 days.
- Necropsy of survivors performed: Yes - Statistics:
- No data
- Preliminary study:
- Not applicable
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: One animal died on Day 4.
- Mortality:
- 1 animal died on day 4
- Clinical signs:
- other: Moderate redness was observed in 10/10 animals. Slight oedema in 3/10 and Moderate oedema in 7/10.
- Gross pathology:
- Liver dark, intestine slightly red and fecal matter dried around anal region in the animal which died.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the available data, the substance is not classified according to the Regulation (EC) No. 1272/2008 and to the GHS as the dermal LD50 is greater than 5000 mg/kg bw in rabbits.
- Executive summary:
In an acute dermal toxicity study (limit test), the skin of ten rabbits was exposed to test material at dose of 5000 mg/kg bw. Animals were observed for mortality and clinical signs at least daily for 14 days. 1/10 animal died on Day 4 post exposure. Dermal irritation was observed in all the animals.
Rabbit Dermal LD50 > 5000 mg/kg bw
Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
This study is considered as acceptable and satisfies the requirement for acute dermal toxicity endpoint.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- The study was non-GLP but was of good quality (Klimish score= 2)
Additional information
Acute toxicity: oral
A study was identified (MB research laboratories, 1977, rel.2). In this acute oral toxicity study, performed similarly to OECD Guideline No. 401, rats were given a single oral dose of test material at 5000 mg/kg bw. Animals were then observed for mortality and clinical signs for 14 days and at the end of the study the surviving animals were sacrificed for necropsy.
No mortality or clinical signs were observed. No abnormalities were noted at necropsy.
This study gave an oral LD50 (rats) > 5000 mg/kg bw.
An other study was identified (Seung-Min Oh, 1997, Rel.2). In this acute oral toxicity study, also performed similarly to OECD Guideline No. 401, rats were given a single oral dose of test material at 5000 mg/kg bw. Animals were then observed for mortality , clinical signs and body weights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination.
No mortality or clinical signs were observed. Test substance treated group showed a significant weight loss from the day of administration of test substance to autopsy day. However, females in this group showed a significant weight loss only during the first 2 days after administration of test substance and gradually recovered thereafter, resulting in no significant weight changes. No abnormalities were noted at necropsy.
This study also gave an oral LD50 (rats) > 5000 mg/kg bw.
A LD50 higher than 2000 mg/kg bw was also found following a single administration of the substance in beagle dogs of both sexes ( 3 animals/sex) with no death observed nor treatment related clinical signs, urinalysis, eye examination, hematology, serum chemistry, organ weight or other findings [You et al., 1997]. This study supports the conclusion that this substance is not acutely toxic.
Acute toxicity: dermal
Not required for substances at the REACH Annex VII tonnage level. However a study was identified (MB research laboratories, 1977, rel.2). In this acute dermal toxicity study (limit test), the skin of 10 rabbits was exposed to test material at dose of 5000 mg/kg bw. Animals were then observed for mortality and clinical signs at least daily for 14 days. 1/10 animal died on Day 4 post exposure. Moderate dermal irritation was observed in all the animals.
This study gave a dermal LD50 (rabbits) > 5000 mg/kg bw.
Reference:
[You et al., 1997] Acute and Subacute Toxicity of l-Muscone in Beagle Dogs. Korean J. Toxicol. Vol. 13, No. 4, pp. 449-460, 1997.
Justification for classification or non-classification
Harmonized classification:
The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self classification:
Acute toxicity via Oral route:
Based on the available information, the substance is:
- not classified according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) as the oral LD50 is higher than 5000 mg/kg bw
- not classified according to the GHS as the oral LD50 is higher than 5000 mg/kg bw.
Acute toxicity via Dermal route:
Based on the available information, the substance is:
- not classified according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) as the dermal LD50 is higher than 5000 mg/kg bw
- not classified according to the GHS as the dermal LD50 is higher than 5000 mg/kg bw.
Acute toxicity (Inhalation):
No data was available. Not required for substances at the REACH Annex VII tonnage level.
Specific target organ toxicity: single exposure (Oral):
The classification criteria according to the Annex VI of the Regulation (EC) No. 1272/2008 as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value (oral) for a Category 1 classification (C ≤ 300 mg/kg bw) and at the guidance value (oral) for a Category 2 classification (2000 mg/kg bw≥C > 300 mg/kg bw). No classification is required.
The criteria for Transient Organ effects (STOT-SE Category 3) according to Annex VI of the Regulation (EC) No. 1272/2008 are not met since narcotic effects were not observed in the acute oral toxicity study.
Specific target organ toxicity: single exposure (Dermal):
The classification criteria according to the Annex VI of the Regulation (EC) No. 1272/2008 as specific target organ toxicant (STOT) – single exposure, dermal are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value (dermal) for a Category 1 classification (C ≤ 300 mg/kg bw) and at the guidance value (dermal) for a Category 2 classification (2000 mg/kg bw≥C > 300 mg/kg bw). No classification is required.
Specific target organ toxicity: single exposure (Inhalation):
No data was available. Not required for substances at the REACH Annex VII tonnage level.
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