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EC number: 232-380-0 | CAS number: 8011-86-7 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 34905.
- 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
LD50 oral acute rat > 2000 mg/Kg bw (test item)
LD50 dermal acut rat > 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:
- April 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Not GLP study but good described study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: First attachments of 30 July 1996 DIRECTIVE 96/54/EC (L 248)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: authorized vendor
- Weight at study initiation: 175 ± 5 g
- Housing: Makrolon cage (48 x 27 x 20 cm), with bedding of wood chips.
- Diet: free access to an experimental diet for rats, provided by an accredited supplier.
- Water: tap water bottles ad libitum
- Acclimation period: 7 days
- Health check: during acclimatation period
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C (± 2°C).
- Humidity (%): 55% (± 25%)
- Air changes (per hr): 15 air change per hour with filtered air (5 µm)
- Photoperiod (hrs dark / hrs light): 12 hours cycle dark/light - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2000 mg for 20 ml of water
- Amount of vehicle : 2 ml of solution for 100 mg of body weight - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3 animals per each sex per dose
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed:
Skin, hair, eyes, mucous membranes, respiratory, circulatory system, central and autonomic nervous system, somatomotor activity and behavior patterns. Particular attention to: tremors, convulsions, salivation, diarrhea, lethargy, sleep and coma. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality observed
- Clinical signs:
- other: no clinical signs observed
- Gross pathology:
- no patology observed after necropsy
- Interpretation of results:
- other: not classified under Regulation 1272/2008
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance was tested following Eu Method B1 for acute oral toxicity in rats. Under the epxerimental conditions the LD50 > 1500 mg/kg bw based on active ingredient, LD50 > 2000 mg/kg test item.
- Executive summary:
The substance was tested for acute toxicity on Wistar rats following EU Method B1. No signs of toxicity are observed during the experiment at dose of 2000 mg/kg bw.
Reference
sacrifice:
All survived animals are killed by CO2 administration
The test was conducted as a limit test, since no mortality was recorded, no further test or analysis are necessary
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:
- other: read across from analogue substance
- Adequacy of study:
- key study
- Study period:
- Since November 23,1989 to December
- Reliability:
- 2 (reliable with restrictions)
- 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
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG
- Age at study initiation: males 11 weeks , females 13 weeks
- Weight at study initiation: males: 256-282 g, females: 199-213 g
- Housing:Individually in Makrolon type-2 cages with standard softwood bedding
- Diet : Pelleted standard Kliba 343, Batch 34/88 rat maintenance diet
- Water : Community tap water from Itingen, ad libitum
- Acclimation period:7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):22 ± 3
- Humidity (%): 40-70 %,
- Air changes (per hr): 10-15 air changes
- Photoperiod: 12 hours cycle dark/light - Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 10%
- Type of wrap if used: occlusive dressing. The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.
- Other: On test day 1 the test article was applied evenly on the skin with a syringe
REMOVAL OF TEST SUBSTANCE
- Washing : lukewarm tap water
TEST MATERIAL
- Amount(s) applied: 4 ml
- Constant volume or concentration used: yes - Duration of exposure:
- 24 h
- Doses:
- 4 ml at 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 x sex x single dose
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations :
mortality/ viability: Four times during test day 1, and daily during days 2 - 15
Body Weights: Test days 1 (pre-administration), 8 and 15.
Symptons: Each animal had an examination for changes in appearance and behavior four times during day 1, and daily during days 2-15. All abnormalities were recorded.
- Necropsy of survivors performed: yes
GENERAL BEHAVIOR
aggressiveness vocalization, restlessness/excitation nervousness, fear sedation, somnolence, sleep, coma
RESPIRATION
apnea ,dyspnea ,rales
EYE
chromodacryorrhea, exophthalmos, miosis, mydriasis, whitish discharge, lid adhesion, negative corneal reflex
NOSE
rhinorrhea, epistaxis
MOTILITY
akinesia, ataxia ,dropped head, hyperkinesia, hypokinesia, paralysis, flaccid paralysis, spastic , paddiing movements, stiff gait, rolling movements
BODY POSITION
ventral body position
latero-abdominai position
hunched posture
MOTOR SUSCEPTIBILITY
spasms, tonic muscle spasms, clonic muscle spasms, opisthotonus, saltatory spasms, trismus retching, "Straub" phenomenon ,tremor ,muscle-twitching ,muscle-twitching, generalized
SKIN
erythema edema, necrosis ,crusts ,scale formations
VARIDUS
loss of weight ,emaciation ,diarrhea ,ruffled fur ,necrosis of tissue of application area , salivation ,pallor, cyanosis
Test item preparation:
The test article was placed into a glass beaker on a tared Mettler PK 300 balance and the vehicle (distilled water) was added. A weight/volume dilution was prepared using .a homogenizer.
Homogeneity of the test article in the vehicle was maintained during treatment using a magnetic stirrer.
The preparation was made immediately prior to dosing. - Statistics:
- The LOGIT-Model couid not be applied to the observed rate of death. The toxi¬city was estimated without use of a statistical model.
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality observed during the test
- Clinical signs:
- other: at 2000 mg/kg: erythema, brown discolored application area, scales (females). The described symptoms were partly observed until termination of test. No systemic symtoms were observed.
- Gross pathology:
- No macroscopic organ changes.
- Interpretation of results:
- other: not classified under Regulation 1272/2008
- Conclusions:
- The analogue substance was tested for acute dermal toxicity following OECd 402. Under the experimental conditions the LD50 (LD0) > 2000 mg/kg bw.
- Executive summary:
The test article was applied to the skin of rats of both sexes for 24 hours at a dose of 2000 mg/kg. The following death rate was observed: 0 % at 2000 mg/kg.
Based on these observations, the LOGIT model could not be applied to the observed rate of death.
Therefore, the toxicity was estimated to be greater than 2000 mg/kg
SYMPTOMS
The following local findings were observed: 2000 mg/kg: erythema, brown discolored application area, scales (females). The described symptoms were partly observed until termination of test. No systemic symtoms were observed.
NECROPSY
The following macroscopic organ changes were observed: No macroscopic organ changes.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Oral exposure pattern is covered by studies on the substance, dermal toxicity is assessed through a very similar substance, and inhalation is not considered as a potential exposure pattern based on the vapour pressure. The oral toxicity has been performed just as a limit test at 2000 mg/Kg bw on the test item, with no effects, it can be concluded that the substance does not arise any concern for acute toxicity by oral route.
For acute dermal toxicity, no studies are available on the substance. A study has been performed on a very similar substance and the results have been taken into account for the assessment. The analogue substance was tsted for acute dermal toxicity and the LD50, LD0 resulted > 2000 mg7kg. Based on the read across considerations same results apply to the target substance.
Justification for classification or non-classification
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 mroe 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.
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 dermal route:
Category 1: ATE <= 50 mg/kg bw
Category 2: 50 < ATE <= 200 mg/kg bw
Category 3: 200 < ATE <= 1000 mg/kg bw
Category 4: 1000 < ATE <= 2000 mg/kg bw
The LD50 of the test substance was determined to be more 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 dermal exposure.
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