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Reaction mass of Chromate(1-), [N-[7-hydroxy-8-[(2-hydroxy-5-nitrophenyl)azo]-1-naphthalenyl]acetamidato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]-, hydrogen, compd. with N-cyclohexylcyclohexanamine (1:1) and hydrogen bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with dicyclohexylamine (1:1) and hydrogen bis[N-[7-hydroxy-8-[(2-hydroxy-5-nitrophenyl)azo]-1-naphthyl]acetamidato(2-)]chromate(1-) , compound with dicyclohexylamine (1:1)
EC number: 916-865-0 | CAS number: -
- 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 acute oral LD50 of the a close analogue of the test substance was determined to be 3250 mg/kg bw.
The acute dermal LD50 of the test substance in rats was determined to be >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:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to the read-across justification attached to section 13.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 3 250 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 2 598 - < 3 902
- Remarks on result:
- other: Result read-across source CAS No. 12237-23-9
- Remarks:
- Correction for molecular weight is not considered
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 250 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:
- 6 Sept. 2016 to 20 Sept. 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- February 24,1987
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- August 1998
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Testing Guideline of 12 Nousan No. 8147, 2000 as this in line with OECD 402
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bioassay - Labor für biologische Analytik GmbH, Im Neuenheimer Feld 515-519, 69120 Heidelberg
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Orasol Black X45
- Test item No.: 16/0051-1
- Batch identification: 002-150504
- EC No.: 916-865-0
- Content: 97.5 g/100 g (100 g/100 g minus water content)
- Homogeneity: The test item was homogeneous by visual inspection.
- Storage stability: Guaranteed by the sponsor, and the sponsor holds this responsibility.
- Expiry date: April 29, 2025
- Storage conditions: Room temperature
- Physical state/ color: Solid / black - Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:Wi (Han) SPF
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Reasons for selection of the test species: Rats were selected since this rodent species is recommended in the respective test guidelines. Wistar rats were selected since there is extensive experience available in the laboratory with this strain of rats.
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: male animals approx. 8 weeks, female animals approx. 12 weeks
- Weight at study initiation: average 230 g (males); average 207.4 g (females)
- Housing: Makrolon cage, type III
- Diet and water : ad libitum
- Acclimation period: at least 5 days before the beginning of the experimental phase
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70 %
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 h / 12 h - Type of coverage:
- semiocclusive
- Vehicle:
- corn oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal and dorsolateral parts of the trunk
- % coverage: About 40 cm² (corresponds to at least 10% of the body surface)
- Type of wrap if used: air-permeable dressing (4 layers of absorbent gauze (Ph. Eur. supplied by Lohmann GmbH & Co., KG) and stretch bandage (Fixomull® Stretch (adhesive fleece) supplied by Beiersdorf AG).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Rinse with warm water
- Time after start of exposure: At the end of the exposure time (24 h)
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mL/kg bw
- Concentration (if solution): 20 g / 100 mL
VEHICLE
- Vehicle: Corn oil Ph.Eur.
- Reason for the vehicle: Good homogeneity in corn oil Ph.Eur.
- Form of application: Suspension - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- weighing: shortly before application, weekly thereafter and on the last day of observation;
- clinical observations: several times on the day of application and at least once during each workday thereafter;
- scoring of skin findings: 30-60 minutes after removal of the dressing, several times thereafter and the last day of observation;
- mortality: at least once each workday
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, local effects (skin reactions), gross pathology - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: No systemic clinical signs were observed during clinical examination
- Gross pathology:
- No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined on the last day of observation.
- Other findings:
- Local effects:
Due to the black discoloration of the application site no erythema was assessable in the male animals from study day 1 until study day 3 after administration. Thereafter no erythema was observed.
Due to the black discoloration of the application site no erythema was assessable in the female animals on study day 1 after administration. Thereafter no erythema was observed. - Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
An acute dermal toxicity test is available for the substance itself. As no acute oral toxicity test is available for the substance itself, a read-across is made to a structural analogue of the substance.
Acute toxicity: Oral (Orasol Black CN, CAS 12237-23-9)
No acute oral study was available for the test substance. A very close analogue of the test substance, consisting of the same constituents in slightly different ratios, was tested and this substance was used as a source substance. The test item was studied in a study similar to OECD test guideline 401. Male (3 -5) and female (2 -5) rats (strain: RAI outdred SPF) were orally administrated via gavage at concentrations of 2.5%; 5%; 15%; 25%; 50% in CMC (carboxymethyl cellulose) as vehicle. The rats were observed for 8 days and examinations of clinical signs, body weight, organ weights were performed. 1/5 males and 2/5 females died at a dose of 3000 mg/kg bw (15%), 5/5 males and 3/5 females at 5000 mg/kg bw (25%) and all animals at 10000 mg/kg bw (50%). In addition, local effects (skin and feces black stained at 500 at concentration of 2.5% and 5%; ataxia, stiff movements, eyes, skin, feces black stained at 15%, 25% and 50%, at the concentration of 25% and 50% also piloerection) were observed with increasing concentration of the test item used. The acute oral LD50 in rats was calculated to be 3250 mg/kg. Based on the available information the test item is not considered to cause acute toxicity via the oral route (Ciba-Geiga Ltd, 1972).
Acute toxicity: Dermal (substance itself, EC 916-865-0)
In an acute dermal toxicity study (Limit Test), according to OECD guideline 402, young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of Orasol Black X45 (as suspension in corn oil Ph.Eur.). The clipped application site (dorsal and dorso-lateral parts of the trunk, comprising at least 10% of the total body surface) was covered by semi-occlusive dressing during the 24-hour exposure period. The animals were observed for 14 days. No mortality or signs of systemic toxicity occurred. Due to the black discoloration of the application site erythema could not be assessed in the male animals from the first till the third study day and in the female animals on first study day after application. Thereafter, no erythema was observed. The body weight of the male and female animals increased within the normal range throughout the study period. However, one female animal did not adequately gain weight during the first week, but gained weight in a normal range during the second week. Due to the fact that stagnation of body weight is commonly known for females after dermal applications, this stagnation is considered to be unspecific. No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study. The LD50 was determined to be > 2000 mg/kg bw. Based on the available information, the test item is not considered to cause acute toxicity via the dermal route (Bioassay, 2016).
Justification for classification or non-classification
Based on the available information classification for acute oral, inhalation or dermal toxicity is not warranted in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.
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