Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 404-600-7 | CAS number: 129009-88-7 EVERZOL ORANGE GR; ORANGE HF-SNK; REAKTIV ORANGE FD 19969 FW
- 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 >2000 mg/kg bw) and dermal toxicity (LD50 >2000 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:
- From May. 22, 1997 to Jun. 17, 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline 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
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst Aktiengesellschaft, Kastengrund, SPF breeding colony
- Age at study initiation: 7 wk (males); 8 wk (females)
- Weight at study initiation: 182± 7 g (males); 164± 2 g (females)
- Fasting period before study: Yes, 16 h
- Housing: MacroIon cages (type 4) on soft wood granulate in groups of 5 animals
- Diet (e.g. ad libitum): ssnif R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): Tap water in plastic bottles, ad libitum
- Acclimation period: At least 7 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3 °C
- Humidity (%): 50±20 °C
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light
IN-LIFE DATES: From: May. 22, 1997 To: Jun. 05, 1997 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20 % suspension in deionized water
- Justification for choice of vehicle: Test substance is soluble in water
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION (if unusual): Test substance was suspended in the stated concentration in deionized water and distributed homogeneously by means of a magnetic stirrer.
The stability and the homogeneity of the test substance in the vehicle was determined by analytical methods. - Doses:
- 2000 mg/kg bw
- 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 twice every day (in the morning and in the afternoon), on weekends and public holidays only once. The animals were weighed weekly.
- Necropsy of survivors performed: yes; animals were killed by carbon dioxide asphyxiation, dissected and examined for macroscopically visible changes.
- Other examinations performed: Clinical signs and body weights - Statistics:
- No data
- Preliminary study:
- No
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No mortalities occurred during the whole study.
- Clinical signs:
- other: Stilted gait, squatting posture, decreased spontaneous activity and orange colored feces. One day after administration the animals were free of clinical symptoms.
- Gross pathology:
- No gross pathology changes observed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the acute oral LD50 of the test substance was found to be >2,000 mg/kg in Wistar rats.
- Executive summary:
A study was conducted to assess the acute oral toxicity of test substance in Wistar rats according EU Method B.1. and OECD guideline 401 in compliance with GLP.
Following a range-finding study, a group of 10 fasted rats (five males and five females) were given a single oral dose of the test substance as a 20 % suspension in deionized water, at a dose level of 2,000 mg/kg. The animals were observed for 14 d after the day of dosing and were then killed and subjected to gross pathological examination. The animals showed stilted gait, squatting posture, decreased spontaneous activity and orange colored feces. One day after administration the animals were free of clinical symptoms. No deaths occurred within the observation period. Development of body weight was not impaired. No abnormalities were noted at necropsy.
Under the test conditions, the acute oral LD50 of the test substance was found to be >2,000 mg/kg in Wistar rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD0
- 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:
- From Aug. 21, 1997 to Oct. 09, 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- 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:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HMR, Kastengrund, SPF breeding colony
- Age at study initiation: 7 wk (males); 8 wk (females)
- Weight at study initiation: 195± 12 g (males); 191± 8 g (females)
- Housing: MacroIon cages (type 3) on soft wood granulate, one animal/cage
- Diet (e.g. ad libitum): ssnif R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): Tap water in plastic bottles, ad libitum
- Acclimation period: At least 1 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3 °C
- Humidity (%): 50±20 °C
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light
IN-LIFE DATES: From: Aug. 21, 1997 To: Sep. 04, 1997 - Type of coverage:
- semiocclusive
- Vehicle:
- water
- Remarks:
- 0.7 mL deionized water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Dorsal skin of the area (30 cm2)
- Type of wrap if used: Elastic plaster bandage fixed around the animal's body (Fixomull and Elastoplast, 8 cm in width)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with warm water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 0.5 g of test substance was moistened with 0.7 mL deionized water
- Constant volume or concentration used: yes
- For solids, paste formed: yes
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.7 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 twice every day (in the morning and in the afternoon), on weekends and public holidays only once. The animals were weighed weekly.
- Necropsy of survivors performed: yes; animals were killed by carbon dioxide asphyxiation, dissected and examined for macroscopically visible changes.
- Other examinations performed: Clinical signs and body weight - Preliminary study:
- Not applicable
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Mortality:
- No mortalities occurred during the whole study.
- Clinical signs:
- other: No symptoms were observed after administration of 2000 mg/kg body weight. The skin of the animals was sporadically discolored light orange up to Day 8 of the study.
- Gross pathology:
- No gross pathological changes were observed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the acute dermal LD50 of the test substance was found to be >2,000 mg/kg in Wistar rats
- Executive summary:
A study was conducted to assess the acute dermal toxicity of test substance in Wistar rats according EU Method B.3. and OECD guideline 402 in compliance with GLP.
Following a range-finding study, a group of 10 rats (five males and five females) were applied 0.5 g of test substance moistened with 0.7 mL deionised water, at a dose level of 2,000 mg/kg. Following the 24 h exposure period, animals were observed for mortality, skin response and general behavior for 14 d and were then killed and subjected to gross pathological examination.
Neither deaths nor symptoms occurred in the study. All animals appeared normal throughout the 24 h exposure period and the 14 d post-exposure observation period. Development of body weight was not impaired. The skin of the animals was sporadically discolored light orange up to Day 8 of the study. The animals killed at the end of the observation period showed no macroscopically visible changes.
Under the test conditions, the acute dermal LD50 of the test substance was found to be >2,000 mg/kg in Wistar rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD0
- 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 according OECD guideline 401 and EU Method B.1.
Following a range-finding study, a group of 10 fasted rats (five males and five females) were given a single oral dose of the test substance as a 20 % suspension in deionized water, at a dose level of 2,000 mg/kg. The animals were observed for 14 d after the day of dosing and were then killed and subjected to gross pathological examination. The animals showed stilted gait, squatting posture, decreased spontaneous activity and orange colored feces. One day after administration the animals were free of clinical symptoms. No deaths occurred within the observation period. Development of body weight was not impaired. No abnormalities were noted at necropsy.
The acute oral LD50 of the test substance was found to be >2,000 mg/kg in Wistar rats (Dr. Jensch U, 1997).
Dermal
A study was conducted to assess the acute dermal toxicity of test substance in Wistar rats according OECD guideline 402 and EU Method B.3.
Following a range-finding study, a group of 10 rats (five males and five females) were applied 0.5 g of test substance moistened with 0.7 mL deionised water, at a dose level of 2,000 mg/kg. Following the 24 h exposure period, animals were observed for mortality, skin response and general behavior for 14 d and were then killed and subjected to gross pathological examination.
Neither deaths nor symptoms occurred in the study. Development of body weight was not impaired. The skin of the animals was sporadically discolored light orange up to Day 8 of the study.The animals killed at the end of the observation period showed no macroscopically visible changes.
The acute dermal LD50 of the test substance was found to be >2,000 mg/kg in Wistar rats (Dr. Jensch U, 1997).
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).
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).
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.