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EC number: 288-422-3 | CAS number: 85721-12-6
- 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
Based on the test result for acute oral toxicity, the tested substance is considered as not toxic for oral route with a LD50 > 2000 mg/kg.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- other: experimental study on similar substance
- Adequacy of study:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Full article with few details on results
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Specific details on test material used for the study:
- The test material was supplied by Tokyo Kasei Kogyo Industry Ltd, Tokyo Japan.
- Species:
- other: mice
- Strain:
- other: ddY
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- 4 Male ddY mice were obtained from Japan SLC Co., Shizuoka, Japan, at 7 weeks of age and used after 1 week of acclimatization.
They were fed commercial pellets MF (Oriental Yeast Industries Co., Tokyo, Japan) and tap water ad libitum throughout the acclimatization period and the experiment.
The animal room was at 20–24 ◦C with a 12 h light–dark cycle. - Route of administration:
- oral: unspecified
- Vehicle:
- other: saline solution
- Details on oral exposure:
- The test substance were dissolved in saline solution.
- Doses:
- All food additives were administered orally at up to 0.5 × LD50 or the limit dose of 2000 mg/kg.
- No. of animals per sex per dose:
- 4
- Control animals:
- not specified
- Preliminary study:
- -
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality
- Clinical signs:
- No data
- Body weight:
- No data
- Gross pathology:
- No data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 > 2000 mg/kg bw
- Executive summary:
Based on the test results, no toxic effect were seen for an oral application of the tested substance.
No death occurred during the fixed dose test.
- Endpoint:
- acute toxicity: oral
- Type of information:
- other: experimental study on similar substance
- Adequacy of study:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: publication with many details on test procedure and results
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Toxicity test performed on pigs for 76 days
- Deviations:
- not specified
- Principles of method if other than guideline:
- Similar to Short term repeated test on pigs for 21 days.
- GLP compliance:
- not specified
- Test type:
- other: 76 days of exposure
- Limit test:
- no
- Species:
- pig
- Strain:
- other: SPF Danish Landrace
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 36 pigs after an accomodation period of 21 days, were distributed according to body weight into 9 groups of 2 males and 2 females.
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- All pigs were dosed by gavage 3 h after feeding in the morning.
The doses administered were rather high and were adjusted in relation to how well they were tolerated as judged by clinical and hematological examination. - Doses:
- 1000 From 1st to 21st day and 1500 mg/kg bw from 22nd to 76th day.
- No. of animals per sex per dose:
- 9 groups of 2 males and 2 females
- Control animals:
- yes
- Remarks:
- untreated
- Details on study design:
- Bodyweight was recorded weekly and food intake daily.
- Preliminary study:
- -
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 1 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality
- Clinical signs:
- The azo dye produced no significant effect on the clinical and hematological parameters.
- Gross pathology:
- No effects were seen for the tested substance.
- Other findings:
- Blood samples were collected from all animals from truncus jugularis 2 days prior to and 5, 19 and 68 days following the start of the dosing period.
On clinical indication further blood samples were collected from single animals. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 is > 1500 mg/kg bw
- Executive summary:
None of the tested azo dyes produced any significant toxic effects on the examined liver and blood parameters on pigs after an oral application of 76 day.
- Endpoint:
- acute toxicity: oral
- Type of information:
- other: experimental study on similar substance
- Adequacy of study:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: HPV program
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Acute oral toxicity test on dogs
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- dog
- Strain:
- other: Mongrel dogs
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Each test animal was individually housed. Food and water were available ad libitum.
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 2 male dogs
- Control animals:
- yes
- Remarks:
- 300 ml of water
- Details on study design:
- Observations were made immediately following dosing and daily thereafter for 7 days.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths at the dose level tested (5000 mg/kg bw).
- Clinical signs:
- Red diarrhea was observed 30 minutes following dosing in one animal, which was followed by emesis. Red urine was reported for the other animal. Red stools were reported for both dogs one day following dosing.
- Body weight:
- From the third day until the seventh day, both animals appeared normal with respect to appetite.
- Gross pathology:
- Gross necropsy revealed fibrotic changes and decreased weight in a kidney of one test animal. This finding was not considered treatment-related but was rather considered to be a chronic lesion. The spleen also appeared enlarged in this test animal.
- Other findings:
- From the third day until the seventh day, both animals appeared normal with respect to appearance, behavior, appetite and elimination.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 > 5000 mg/kg bw
- Executive summary:
The tested substance does not show toxic effect on oral application of 5000 mg/kg bw to two male dogs.
- Endpoint:
- acute toxicity: oral
- Type of information:
- other: experimental study on similar substance
- Adequacy of study:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: HPV program
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Acute oral toxicity test on rats
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The animals were housed in metal cages suspended above the droppings. Food and water were available ad libitum.
Six groups of 5 males and 5 females. - Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Doses:
- 215, 464, 1000, 2150, 4640, and 10,000 mg/kg bw.
- No. of animals per sex per dose:
- 4 male and 4 females rats
- Control animals:
- not specified
- Details on study design:
- Observations were made immediately following dosing, at 1, 4, 24, 48 hours and once daily thereafter up to 14 days
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths at the dose level tested.
- Clinical signs:
- Clinical observations were normal with the exception of red-colored feces in both sexes at all dose levels and red-colored urine at the three highest dose levels in the female animals.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 > 10000 mg/kg bw
- Executive summary:
The tested substance does not show toxic effect on oral application to six groups of 5 male and 5 female rats.
Referenceopen allclose all
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
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
There are different test performed on
similar substance related to oral toxicity.
One test was performed following OECD 420 showed a LD50 > 1000 mg/kg
since it was the highest tested dose.
Some other subacute studies are available performed on different animals
with the following results:
LD50 rats > 10000 mg/kg bw
LD50 dogs > 5000 mg/kb bw
LD50 pigs > 1500 mg/kg bw
Based on the available results, the LD50 of
the tested substance was fixed to > 2000 mg/kg bw.
According to the CLP Regulation (EC n. 1272/2008), table 3.1.1, Acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories:
For Acute toxicity oral route:
Category 1: ATE <= 5 mg/kg bw
Category 2: 5 < ATE <= 50 mg/kg bw
Category 3: 50 < ATE <= 300 mg/kg bw
Category 4: 300 < ATE <= 2000 mg/kg bw
The LD50 of the test substance was determined to be greater than 2000 mg/kg bw in the chosen reference test, which is outside the above criteria. Therefore, the test substance is not classified for Acute toxicity by oral exposure.
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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