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EC number: 432-840-2 | CAS number: 220926-97-6
- 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
E96095 is not classified according to the CLP Regulation (1272/2008) as LD50 was found to be higher than 2000 mg/kg b.w. for both acute oral toxicity and acute dermal toxicity .
E96095 is classified as harmful by inhalation (R20) according to the Directive 67/548/CEE and in the Category IV according to the CLP Regulation (1272/2008) for acute inhalation toxicity as LC50 was 5.08 mg/L for rat combined sex corresponding to 3.56 mg/L when considering the respirable particles (< 7 µm diameter).
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)
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- The lowest value recorded for humidity (24%) was outside the range of 30-70%
- Principles of method if other than guideline:
- Not relevant
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
Reference
Table 7.2.1/1: signs of reaction to treatment
Clinical signs |
No. of rats in groups of 3 showing signs |
|
Dose (mg/kg b.w.) |
||
2000 |
||
M |
F |
|
Piloerection |
3 |
3 |
Hunched posture |
3 |
3 |
Abnormal faeces |
0 |
1 |
Ungroomed appearance |
0 |
1 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Study complete and sufficient to fulfill the endpoint requirements.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1300 (Acute inhalation toxicity)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- 3.97 mg/L air (analytical)
- 95% CL:
- >= 2.25 - <= 5.69
- Exp. duration:
- 4 h
- Sex:
- female
- Dose descriptor:
- LC50
- Effect level:
- 7.42 mg/L air (analytical)
- 95% CL:
- >= -4.75 - <= 19.6
- Exp. duration:
- 4 h
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 5.08 mg/L air (analytical)
- 95% CL:
- >= 1.9 - <= 8.27
- Exp. duration:
- 4 h
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- 2.79 other: mg/L (respirable component, i.e. < 7µm)
- 95% CL:
- >= 1.73 - <= 3.85
- Exp. duration:
- 4 h
- Sex:
- female
- Dose descriptor:
- LC50
- Effect level:
- 5.03 other: mg/L (respirable component, i.e. < 7 µm))
- 95% CL:
- >= -2.47 - <= 12.53
- Exp. duration:
- 4 h
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 3.56 other: mg/L (respirable component, i.e. < 7 µm)
- 95% CL:
- >= 1.47 - <= 5.64
- Exp. duration:
- 4 h
Reference
Table 7.2.2/3: lung weights in decedents and 14 days after exposure in survivors
Group |
Lung weight |
|||
Males |
Females |
|||
Decedent |
Survivor |
Decedent |
Survivor |
|
Control |
|
1.77 ± 0.100 |
|
1.31 ± 0.090 |
0.77 mg/L |
|
1.81 ± 0.119 |
1.43 ± 0.116 |
|
2.26 mg/L |
|
1.83 ± 0.197 |
2.89 |
1.50 ± 0.115 |
5.30 mg/L |
1.75 |
3.66 ± 0.429 |
3.18 |
2.47 ± 0.266 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 3 560 mg/m³ air
- Quality of whole database:
- Study complete and sufficient to fulfill the endpoint requirements.
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)
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- humidity value below the range (24 %)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Principles of method if other than guideline:
- Not applicable
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Type of coverage:
- occlusive
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
Reference
Table 7.2.3./2: Number of animals dead and number with evident toxicity
Dose (mg/kg bw) |
Conc. In vehicle (% w/v) |
Mortality (dead/total) |
Time range of deaths (hours) |
Number with evident toxicity |
||||
Male |
Female |
Combined |
Male |
Female |
Combined |
|||
2000 |
50 |
0 |
0 |
0 |
- |
0 |
0 |
0 |
Table 7.2.3./3: Mean irritant/corrosive data at 24, 48 and 72 -hour observations
Score at time point / Reversibility |
Erythema (mean score) Max. score: 4 |
Edema (mean score) Max. score: 4 |
24 h |
1.2 |
0.9 |
48 h |
0.6 |
0.3 |
72 h |
0.4 |
0.3 |
Average 24h, 48h, 72h |
0.73 |
0.5 |
Reversibility |
c* |
c* |
Average time (unit) for reversion |
Day 7 |
Day 7 |
c =completely reversible
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Study complete and sufficient to fulfill the endpoint requirements.
Additional information
E96095 was tested for acute oral toxicity according to OECD 423 guideline and in compliance with GLP. Groups of rats (3 /sex) were administered by gavage a single dose of E96095 at 2000 mg/kg b.w.. No mortality was observed throughout the 14-day observation period. Body weight gain was not affected by treatment. At necropsy, macroscopic examination of main organs showed no abnormalities.
E96095 was tested for acute dermal toxicity in CD Sprague-Dawley rats in a limit dose assay performed according to OECD guideline No 402 in compliance with GLP. Groups of rats (5/sex) were administered a single dermal dose of E96095 at 2000 mg/kg b.w. in corn oil. No death and clinical sign occurred during the 14-day observation period.
E96095 was tested for acute inhalation toxicity in rats according to a protocol similar to OECD 403 guideline in compliance with GLP. The assay was conducted on groups of rats (5/sex) exposed for at 0, 0.77, 2.26 and 5.30 mg/L particulate aerosol for 4 hours. Fast breathing rate, strong mortality (6/10 animals) and increased lung weights compared to controls were observed in the highest dose group. The acute inhalation LD50 for E96095 particle aerosol was 5.08 mg/L for rat combined sex corresponding to 3.56 mg/L when considering the respirable particles (< 7 µm diameter).
Justification for selection of acute toxicity – oral endpoint
Study performed according to the OECD guideline 423 and GLP compliant.
Justification for selection of acute toxicity – inhalation endpoint
Study performed according to the OECD guideline 403 and GLP compliant.
Justification for selection of acute toxicity – dermal endpoint
Study performed according to the OECD guideline 402 and GLP compliant.
Justification for classification or non-classification
As no mortality was observed at 2000 mg/kg b.w. in an acute oral toxicity study performed according to OECD 423 guideline and in compliance with GLP, E96095 is not classified for acute oral toxicity according to the Annex VI to the CLP Regulation (1272/2008).
As no death and clinical sign was observed at 2000 mg/kg b.w. in an acute dermal toxicity study performed according to OECD 402 guideline and in compliance with GLP, E96095 is not classified for acute dermal toxicity according to the Annex VI to the CLP Regulation (1272/2008).
As LC50 for E96095 acute inhalation particle aerosol was 5.08 mg/L for rat combined sex corresponding to 3.56 mg/L when considering the respirable particles (< 7 µm diameter), E96095 is classified as harmful by inhalation (R20) and in the Category IV according to the Annex VI to the CLP Regulation (1272/2008).
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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