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EC number: 246-307-5 | CAS number: 24544-08-9
- 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 test item was tested in acute studies by oral and dermal application on rats. Both studies were conducted in accordance with GLP and following OECD-guidelines. Significant substance-related effects were observed in both tests, therefore the test item needs to be classified as "harmful".
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:
- April 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen (Germany)
- Strain: Bor: WISW (SPF Cpb)
- Age at study initiation: Males 8 weeks and females 10 weeks
- Weight at study initiation: mean males 190 g and females 171 g
- Fasting period before study: 16 hours before treatment
- Housing: gang housing à 5 animals per cage and sex
- Diet (e.g. ad libitum): Altromin® 1324 Pellets (manufacturer: Altromin GmbH und Co KG, Lage, Germany)
- Water (e.g. ad libitum): tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 50 +/- 10%
- Air changes (per hr): 10 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours (6 hours artificial light) - Route of administration:
- oral: gavage
- Vehicle:
- peanut oil
- Doses:
- 200, 312, 630, 1000 and 2000 mng/kg
- No. of animals per sex per dose:
- 5 animals per sex and dose
- Control animals:
- no
- Preliminary study:
- no pretest
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 443 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 630 mg/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 312 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 200 mg/kg:
No mortality was observed in both sexes.
312 mg/kg:
No mortality was noted in males, whereas one female was found dead five days after treatment.
630 mg/kg:
Four out of five male animals were found dead between days 1 to 4 after dosing. All females died within two to three days after treatment.
1000 mg/kg and 2000 mg/kg:
All males and females died within 2 days after dosing. - Clinical signs:
- other: 200 mg/kg: Salivation and ruffled fur was noted in some animals. 312 mg/kg up to 2000 mg/kg: In addition to salivation and ruffled fur, males and females aat these dose levels showed also sedation, gasping, chromodacryorrhoe, tremor, unsteady gait and ov
- Gross pathology:
- 200 mg/kg:
One surviving male showed pale discolored kidneys.
312 mg/kg:
No treatment-related findings observed.
630 mg/kg up to 2000 mg/kg:
Aerogastria, red or black discoloured mucuous mebranes of the stomach and small intestines were noted in both sexes. Females died at 630 mg/kg also showed pale discolored livers. There were some further findings in one died male and in one surviving male. - Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral LD50 on Wistar rats was found to be 443 mg/kg.
- Executive summary:
The acute oral LD50 study was conducted as GLP-study according to OECD no. 401. The test was performed as full test on male and female Wistar rats with doses of 200, 312, 630, 1000 and 2000 mg/kg. Mortality occured at concentrations of 312 mg/kg and above, slight to moderate clinical symptoms were noted in almost all dose groups, body weight gain was slightly reduced in surviving males at 312 mg/kg and above. At necrospy, a number of treatment-related effects were noted, such as salivation, ruffled fur, discolored kidneys and liver etc. in all dose groups.
Therefore, based on the oral LD50 of 443 mg/kg, the test item has to be classified as harmful.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 443 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:
- April - June 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen (Germany)
- Strain: Bor: WISW (SPF Cpb)
- Age at study initiation: Males ca. 10 weeks and females ca. 15 weeks
- Weight at study initiation: mean males 253 g and females 215 g
- Fasting period before study: 16 hours before treatment
- Housing: gang housing à 5 animals per cage and sex
- Diet (e.g. ad libitum): Altromin® 1324 Pellets (manufacturer: Altromin GmbH und Co KG, Lage, Germany)
- Water (e.g. ad libitum): tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 50 +/- 10%
- Air changes (per hr): 10 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours (artificial light) - Type of coverage:
- semiocclusive
- Vehicle:
- peanut oil
- Duration of exposure:
- 24 hours
- Doses:
- 100, 1000 and 2000 mg/kg
- No. of animals per sex per dose:
- 5 animals per sex and dose
- Control animals:
- no
- Preliminary study:
- Due to high mortality observed in an acute oral toxicity study on rats, 100 and 1000 mg/kg were tested in addition to the limit dose of 2000 mg/kg.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 703 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 100 mg/kg:
No mortality was observed in both sexes.
1000 mg/kg:
No mortality was noted in males, whereas one female was found dead four days after treatment.
2000 mg/kg:
One out of five male animals was found dead on day 4 after dosing. Three out of five females after 3-4 days after dosing. - Clinical signs:
- other: 100 mg/kg: No treatment-related effects observed. 1000 mg/kg and 2000 mg/kg: Most of males and females at these dose levels showed gasping, dyspnea, chromodacryorrhoe, unsteady gait, bloody snouts and overall bad condition. Clinical signs appeared four
- Gross pathology:
- Animals found dead showed red discolored lungs, bllody snouts and small intestines partly discolored black.
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal LD50 on female Wistar rats was found to be 1703 mg/kg.
- Executive summary:
The acute dermal LD50 study was conducted as GLP-study according to OECD no. 402. The test was performed as full test on male and female Wistar rats with doses of 100, 1000 and 2000 mg/kg. Mortality occured at concentrations of 1000 mg/kg and above, slight to moderate clinical symptoms were noted in mid and high dose groups, body weight gain was slightly reduced in all dose groups. At necrospy, a number of treatment-related effects were noted, such as tremor, dyspmea, bloody snouts etc. were recorded in all dose groups.
Therefore, based on the dermal LD50 of 1703 mg/kg in female rats, the test item has to be classified as harmful..
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 703 mg/kg bw
Additional information
Key study: Acute toxicity – oral
The GLP-study was carried in accordance with EU Method B.1 and OECD Guideline 401 (Acute Oral Toxicity). Five dose groups were tested per sex. 5 males and 5 females were treated by gavage with doses from 200 up to 2000 mg/kg. Mortality occured at concentrations of 312 mg/kg and above, slight to moderate clinical symptoms were noted in almost all dose groups, body weight gain was slightly reduced in surviving males at 312 mg/kg and above. At necrospy, a number of treatment-related effects were noted, such as salivation, ruffled fur, discolored kidneys and liver etc. in all dose groups. In conclusion, the acute oral LD50 was determined to be 443 mg/kg and the test item has to be classified as harmful.
Key study: Acute toxicity – dermal
The study was conducted as GLP-study according to OECD no. 402. The test was performed as full test on male and female Wistar rats with doses of 100, 1000 and 2000 mg/kg. Mortality occured at concentrations of 1000 mg/kg and above, slight to moderate clinical symptoms were noted in mid and high dose groups, body weight gain was slightly reduced in all dose groups. At necrospy, a number of treatment-related effects were noted, such as tremor, dyspmea, bloody snouts etc. were recorded in all dose groups.
Therefore, based on the dermal LD50 of 1703 mg/kg in female rats, the test item has to be classified as harmful.
Justification for selection of acute toxicity – oral endpoint
GLP study following OECD-guideline; Klimisch 1
Justification for selection of acute toxicity – dermal endpoint
GLP study following OECD-guideline; Klimisch 1
Justification for classification or non-classification
Based on the data available, the substance has to be classified and labelled according to Directive 67/548/EEC (DSD) or Regulation 1272/2008/EC (CLP):
REGULATION (EC) No 1272/2008
Pictogram: Exclamation mark
Signal word: Warning
Hazard statements: H302 - Harmful if swallowed / H312 - Harmful in contact with skin.
Precautionary statements: P280 - Wear protective gloves/ protective clothing/ eye protection/ face protection
P301 + P312 : IF SWALLOWED: Call a POISON CENTER or doctor/ physician if you feel unwell.
67/548/EC - 1999/45/EC
Symbol: Harmful
R-phrases: R21/22 - Harmful in contact with skin and if swallowed.
S-phrases: S24/25 - Avoid contact with skin and eyes.
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