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EC number: 228-762-1 | CAS number: 6358-09-4
- 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 repeated dose oral toxicity study of Chlororange (2-amino-6-chloro-4-nitrophenol) was performed by following methods similar to the OECD Guideline 408 (Repeated Dose 90 -Day Oral Toxicity in Rodents).
Male and female rats were assigned to 4 groups (15 animals/sex/group;for control and 90 mg/kg dose groups an additional 10 animals/sex formed recovery groups) and were treated for 90 days as follows:
Group 1: Control (0.5% Carboxymethylcellulose)
Group 2: 10 mg/kg bw/day
Group 3: 30 mg/kg bw/day
Group 4: 90 mg/kg bw/day
No animals died during the study. No adverse clinical signs, except for an orange-red discoloration of urines in the mid and high dose animals, were observed. Body weight gain rates were significantly reduced in high-dose males during the second half of the study. The reduced male body weight was nearly compensated by significantly increased weight gain rates during the recovery period. No significant differences were seen in food consumption andfood conversion ratios.
Hematological investigation revealed intergroup differences in prothrombin time, leukocyte and reticulocyte count, which occurred sporadically within the limits of the normal range. Clinical chemistry values indicated several statistical significant intergroup differences. These changes, however, were not persistent, not dose-related and randomly sex-related and were therefore considered to be coincidental.
No test substance-related findings were seen at terminal autopsy. Organ weight changes of the liver, lung and thymus of males and females in the high dose and recovery groups were not consistent. However, increases in kidney weight were found in males and females both of the high dose and recovery groups. The histomorphological examinations revealed no treatment related organ alterations in high-dose group animals.
Based on above, treatment related adverse effects were observed at the highest tested dose level i.e.90 mg/kg bw/day (reduced body weight and increased kidney weights).
In conclusion, Chlororange (2-amino-6-chloro-4-nitrophenol) when administered by oral gavage daily for 13 weeks to male and female Crl: Wi/Br strain Wistar rats at dose levels of 0, 10, 30 and 90 mg/kg bw/day, revealed a no observed adverse effect level (NOAEL) at 30 mg/kg bw/day for male and female rats.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 30 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- reliability 1
Additional information
Justification for classification or non-classification
The repeated dose oral toxicity study of Chlororange (2-amino-6-chloro-4-nitrophenol) was performed by following methods similar to the OECD Guideline 408 (Repeated Dose 90 -Day Oral Toxicity in Rodents): No animals died during the study. No adverse clinical signs, except for an orange-red discoloration of urines in the mid and high dose animals, were observed. Body weight gain rates were significantly reduced in high-dose males during the second half of the study. The reduced male body weight was nearly compensated by significantly increased weight gain rates during the recovery period. No significant differences were seen in food consumption andfood conversion ratios.
Hematological investigation revealed intergroup differences in prothrombin time, leukocyte and reticulocyte count, which occurred sporadically within the limits of the normal range. Clinical chemistry values indicated several statistical significant intergroup differences. These changes, however, were not persistent, not dose-related and randomly sex-related and were therefore considered to be coincidental.
No test substance-related findings were seen at terminal autopsy. Organ weight changes of the liver, lung and thymus of males and females in the high dose and recovery groups were not consistent. However, increases in kidney weight were found in males and females both of the high dose and recovery groups. The histomorphological examinations revealed no treatment related organ alterations in high-dose group animals.
Based on above, treatment related adverse effects were observed at the highest tested dose level i.e.90 mg/kg bw/day (reduced body weight and increased kidney weights).
In conclusion, Chlororange (2-amino-6-chloro-4-nitrophenol) when administered by oral gavage daily for 13 weeks to male and female Crl: Wi/Br strain Wistar rats at dose levels of 0, 10, 30 and 90 mg/kg bw/day, revealed a no observed adverse effect level (NOAEL) at 30 mg/kg bw/day for male and female rats. According to CLP criteria, there was no sufficient adverse effect to determined a STOT effect.
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