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EC number: 407-420-7 | CAS number: -
- 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
The available data for test substance indicates a low potential for acute oral (LD50 >2,000 mg/kg bw) and dermal toxicity (LD50 >2,000 mg/kg bw).
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
- Study period:
- Apr-Mar, 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted equivalent or similar to EU Method B.1. and OECD Guideline 401 in compliance with GLP
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Crl:(WI)BR strain
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Limited, Manston Road, Margate, Kent, UK
- Age at study initiation: 7-8 wk males and 9-10 wk females
- Weight at study initiation: 176-198 g (males) and 191-212 g (females)
- Fasting period before study: Yes, 24 h
- Housing: Suspended cages (26.5cm x 50.0cm x 20.7cm) made of stainless steel, one side being solid and the remainder wire mesh
- Diet (e.g. ad libitum): Porton Combined Diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 6 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±2 °C
- Humidity (%): 55±25 %
- Air changes (per hr): 25-30
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION (if unusual): Test substance was suspended in corn oil. The volume of the dose was calculated for each animal according to its weight at the time of dosing, and was adjusted for water content, - Doses:
- 2000 mg/kg bw (adjusted for water content)
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Symptoms were recorded once within 2 h of dosing and again between 4 and 7 h after dosing on the day of dosing and there after once a day up to Day 15. The animals were weighed on Day -1, 1 3, 4, 8 and 15.
- Necropsy of survivors performed: yes; animals were killed by inhalation of excessive levels of halothane vapour followed by exsanguination - Statistics:
- No data
- Preliminary study:
- No data
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: -
- Mortality:
- No mortalities occurred during the whole study.
- Clinical signs:
- other: There were no significant signs of toxicity
- Gross pathology:
- No significant gross pathology changes observed
- Other findings:
- No data
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, the acute oral medial lethal dose (LD50) of the test substance was found to be >2,000 mg/kg in male and female wistar rats.
- Executive summary:
A study was conducted to assess the acute oral toxicity of test substance in wistar rats equivalent or similar to EU Method B.1. and OECD guideline 401 in compliance with GLP.
A group of five male and five female rats received a single oral dose of 2000mg/kg (adjusted for water content) of the test sample as a preparation in corn oil. The animals were assessed daily for any signs of toxicity and their bodyweights were recorded at intervals.
None of the animals died and there were no significant signs of toxicity. There were no treatment-related abnormalities at post mortem examination. The acute oral median lethal dose was in excess of 2000mg/kg to male and female rats.
Under the test conditions, the acute oral medial lethal dose (LD50) of the test substance was found to be >2,000 mg/kg in male and female wistar rats.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
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
- Study period:
- Apr-Mar, 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted equivalent or similar to EU Method B.3. and OECD Guideline 402 in compliance with GLP
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Crl:(WI)BR strain
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Limited, Manston Road, Margate, Kent, UK
- Age at study initiation: 7-8 wk males and 9-10 wk females
- Weight at study initiation: 184-195 g (males) and 199-221 g (females)
- Fasting period before study: Yes, 24 h
- Housing: Suspended cages (26.5cm x 50.0cm x 20.7cm) made of stainless steel, one side being solid and the remainder wire mesh
- Diet (e.g. ad libitum): Porton Combined Diet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 6 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±2 °C
- Humidity (%): 55±15 %
- Air changes (per hr): 25-30
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light - Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Dorso-lumbar area
- Type of wrap if used: The gauze patch was then covered by a patch of plastic film (7.5cm x 5cm) and was held in position using adhesive bandage (25cm x 5cm). This was secured by two pieces of PVC tape (approximately 2.5cm x 20cm) wrapped around the animal
REMOVAL OF TEST SUBSTANCE
- Washing (if done): using clean swabs of absorbent cotton wool soaked in clean warm water and was then dried gently with clean tissue paper
- Time after start of exposure: 24 h
TEST MATERIAL
- Concentration (if solution): Appropriate amount of test substance was moistened with 0.3 mL deionized water
- Constant volume or concentration used: yes
- For solids, paste formed: yes
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.3 mL deionized water. - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Symptoms were recorded once within 4 h of dosing and then after once daily day up to Day 15. The animals were weighed on Day 1, 3, 4, 8 and 15.
- Necropsy of survivors performed: yes; animals were killed by inhalation of excessive levels of halothane vapour followed by exsanguination - Statistics:
- No data
- Preliminary study:
- Not applicable
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: -
- Mortality:
- No mortalities occurred during the whole study.
- Clinical signs:
- other: No symptoms were observed after administration of 2000 mg/kg body weight. Signs of skin irritation consisting of slight to moderate or extreme erythema and slight or moderate oedema, were seen in all animals for 2 d after dosing. Scabs were also observed
- Gross pathology:
- No gross pathological changes were observed
No significant gross pathology changes observed
- Other findings:
- The test substance caused slight to moderate or extreme local skin irritation.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, the acute dermal medial lethal dose (LD50) of the test substance was found to be >2,000 mg/kg in male and female wistar rats.
- Executive summary:
A study was conducted to assess the acute dermal toxicity of test substance in wistar rats equivalent or similar to EU Method B.3. and OECD guideline 402 in compliance with GLP.
A group of five male and five female rats received a single dermal dose of 2000mg/kg (adjusted for water content) of the test sample as supplied. The animals were assessed daily for any signs of toxicity and their bodyweights were recorded at intervals.
None of the animals died and there were no significant signs of toxicity. There were no treatment-related abnormalities at post mortem examination. Signs of slight to moderate or severe irritation were seen in all animals but all signs of irritation had disappeared by Day 5.
The acute dermal median lethal dose was in excess of 2000mg/kg to male and female rats.
Under the test conditions, the acute dermal medial lethal dose (LD50) of the test substance was found to be >2,000 mg/kg in male and female wistar rats.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Oral
A study was conducted to assess the acute oral toxicity of test substance in wistar rats equivalent or similar to OECD guideline 401 and EU Method B.1.
A group of five male and five female rats received a single oral dose of 2000 mg/kg (adjusted for water content) of the test sample as a preparation in corn oil. The animals were assessed daily for any signs of toxicity and their bodyweights were recorded at intervals.
None of the animals died and there were no significant signs of toxicity. There were no treatment-related abnormalities at post mortem examination. The acute oral median lethal dose was in excess of 2000 mg/kg to male and female rats.
The acute oral medial lethal dose (LD50) of the test substance was found to be >2000 mg/kg in male and female wistar rats (Parr-Dobrzanski R J & Leah AM, 1991).
Dermal
A study was conducted to assess the acute dermal toxicity of test substance in wistar rats equivalent or similar to OECD guideline 402 and EU Method B.3.
A group of five male and five female rats received a single dermal dose of 2000 mg/kg (adjusted for water content) of the test sample as supplied. The animals were assessed daily for any signs of toxicity and their bodyweights were recorded at intervals.
None of the animals died and there were no significant signs of toxicity. There were no treatment-related abnormalities at post mortem examination. Signs of slight to moderate or severe irritation were seen in all animals but all signs of irritation had disappeared by Day 5. The acute dermal median lethal dose was in excess of 2000 mg/kg to male and female rats.
The acute dermal medial lethal dose (LD50) of the test substance was found to be >2000 mg/kg in male and female wistar rats (Parr-Dobrzanski R J & Leah AM, 1991).
Justification for classification or non-classification
The available data for test substance indicates a low potential for acute oral (LD50 >2,000 mg/kg bw) and dermal toxicity (LD50 >2,000 mg/kg bw) and does not meet the requirement for classification according to EC criteria (67/548/EEC) and according to CLP criteria (EC 1272/2008).
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