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Reaction mass of hydrogen [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1) and hydrogen bis[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1) and hydrogen bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)
EC number: 916-881-8 | 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 January 1993 to 20 January 1993.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction mass of hydrogen [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1) and hydrogen bis[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1) and hydrogen bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)
- IUPAC Name:
- Reaction mass of hydrogen [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1) and hydrogen bis[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1) and hydrogen bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Description: Black powder
- Storage Conditions: Room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Approximately ten to fourteen weeks old.
- Weight at study initiation: Male rats weighed 216 - 252 g and female rats weighed 209 - 228 g.
- Housing: The animals were housed in suspended polypropylene cages furnished with softwood sawdust. The animals were housed individually during the 24-hour exposure period and in groups of five, by sex, for the remainder of the study.
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: At least five days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21 °C
- Humidity (%): 52 - 67 %
- Air changes (per hr): Approximately 15 changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours darkness.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The test material was used as supplied.
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 5 cm x 4 cm of dermal surface area
- % coverage: approximating to 10 % of the total body surface area.
- Type of wrap if used: A piece of surgical gauze measuring 7 cm x 4 cm was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage (HYPERTIE). The bandage was further secured with a piece of BLENDERM wrapped around each end.
REMOVAL OF TEST SUBSTANCE
- Washing: The bandage was carefully removed and the treated skin and surrounding hair were wiped with cotton wool moistened with arachis oil to remove any residual test material.
- Time after start of exposure: After the 24-hour contact period.
TEST MATERIAL
- For solids, paste formed: No. The test material was applied uniformly to an area of shorn skin which had previously been moistened with arachis oil B.P.
- Duration of exposure:
- 24 hours
- Doses:
- 2 000 mg/kg
- No. of animals per sex per dose:
- Five males and five females.
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: The animals were observed for deaths or overt signs of toxicity at 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days.
- Frequency of weighing: Individual bodyweights were recorded prior to application of the test material on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: At the end of the study the animals were killed by cervical dislocation and subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.
- Other examinations performed: Adverse dermal reactions, if present, were recorded. Data evaluations included the relationship, if any, between the animals' exposure to the test material and the increased incidence and severity of all abnormalities including behavioural and clinical observations, gross lesions, bodyweight changes, mortality and any other toxicological effects.
- Other: On the day before treatment, the back and flanks of each animal were clipped free of hair using veterinary clippers. - Statistics:
- Using the mortality data obtained, an estimate of the acute dermal median lethal dose (LD50) of the test material was made.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths throughout the duration of the test.
- Clinical signs:
- other: No signs of systemic toxicity were noted during the study. Black staining of the fur was commonly noted during the study.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- Dermal reactions: Desquamation was noted at the treatment sites of all animals four and five days after dosing and persisted at the treatment sites of two animals up to seven days after dosing. No other signs of skin irritation were noted.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified in accordance with EU criteria.
- Conclusions:
- Under the conditions of the study, the acute LD50 of the test material in the Sprague-Dawley rat was greater than 2 000 mg/kg bodyweight.
- Executive summary:
A study was conducted to investigate the potential of the test material to cause acute dermal toxicity in rats in accordance to the standardised guidelines OECD 402 and EU method B3 under GLP conditions.
A group of ten animals (five males and five females) were given a single 24-hour, semi-occluded dermal application to intact skin at a dose level of 2 000 mg/kg bodyweight. The animals were observed for fourteen days after the day of treatment and were then euthanised for gross pathological examination.
There were no deaths throughout the study and no signs of systemic toxicity were noted during the study. Desquamation was noted at the treatment sites of all animals. All animals showed expected gain in bodyweight during the study. No abnormalities were noted at necropsy.
Under the conditions of the study, the acute dermal LD50 of the test material in the Sprague-Dawley rat was found to be greater than 2 000 mg/kg bodyweight.
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