Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 297-025-4 | CAS number: 93281-13-1
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From September 27 to October 18t, 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- adopted February 24t, 1987
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Direct Black 168
- IUPAC Name:
- Direct Black 168
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd.
- Age at study initiation: 8 weeks males; 10 weeks females.
- Weight at study initiation: 191 - 206 g males; 168 - 181 g females.
- Fasting period before study: 12 - 18 hours before test administration. Access to water was not interrupted. 2-3 hours after dosing food was again presented.
- Housing: groups of five in Makrolon type-3 cages with standard softwood bedding.
- Diet: pelleted standard Kliba 343, rat maintenance diet, ad libitum.
- Water: community tap water from Itingen, ad libitum.
- Acclimation: one week under laboratory conditions, after veterinary examination.
HUSBANDRY CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 40 - 70 %
- Air changes: 10 - 15 air changes per hour.
- Photoperiod: 12hrs dark / 12 hrs artifical fluorescent light.
- Other: room was airconditioned, music during the light period.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- bi-distilled
- Details on oral exposure:
- APPLICATION VOLUME/Kg bw
10 ml at 2000 mg/kg
PREPARATION
The test article was placed into a glass beaker on a tared balance and the vehicle was added. A weight by volume dilution was prepared using a homogenizer. Homogeneity of the test article in the vehicle maintained during treatment using a magentic stirrer.
The preparation was made immediately prior to dosing. - Doses:
- 10 ml at 2000 mg/kg b.w.
- 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: 15 days.
- Clinical signs observed: each animal was examined for changes in appearance and behaviour four times during day 1, and daily during days 2-15. All abnormalities were recorded. The animals were checked for the following clinical signs: aggressiveness, vocalization, restlessness / excitation, nervousness, fear, sedation, somnolence, sleep, coma, rhinorrhea, epistaxis, apnea, dyspnea, rales, chromodacryorrhea, exophthalmos, miosis, mydriasis, whitish discharge, lid adhesion, lacrimation, negative corneal reflex, akinesia, ataxia, dropped head, hyperkinesia, hypokinesia, paralysis, flaccid, paralysis, spastic, paddling movements, stiff gait, rolling movements, ventral body position, latero-abdominal position, hunched posture, spasms, tonic muscle spasms, clonic muscle spasms, opisthotonus, saltatory, spasms, trismus, tremor, muscle-twitching emaciation and muscle-twitching generalized, erythema, edema, necrosis, loss of weight, diarrhea, ruffled fur, salivation, pallor, cyanosis.
- Frequency of observations: mortality/viability were recorded four times during test day 1(at 1, 2, 3 and 5 hours) and daily during days 2 - 15.
- Frequency of weighing: test day 1 (pre-administration), day 8 and 15.
- Necropsy: necropsies were performed by experienced prosectors. All animals were necropsied. All the animals which survived until the scheduled termination were euthanized by intraperitoneal injection of sodium pentobarbitone. - Statistics:
- The LOGIT-Model could not be applied to the observed rates of death. The toxicity was estimated without the use of a statistical model.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred up to 15 days post-treatment.
- Clinical signs:
- other: 2000 mg/kg: males/females exhibited ruffled fur, diarrhea, hunched posture. Males exhibited sedated. All animals had recovered after 10 observation days.
- Gross pathology:
- No obvious macroscopical organ findings were seen in any animal.
Any other information on results incl. tables
Clinical signs
Summary
Test day |
1 | 1 | 1 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 |
Time after treatment (hrs) | 1 | 2 | 3 | 5 | ||||||||||||||
Males |
||||||||||||||||||
Behaviour sedated | - | - | - | x | - | - | - | - | - | - | - | - | - | - | - | - | - | - |
Hunched posture | x | x | x | x | x | x | x | x | x | - | - | - | - | - | - | - | - | - |
Ruffled fur | x | x | x | x | x | x | x | x | x | x | x | x | x | - | - | - | - | - |
Diarrhea | - | x | x | x | x | - | - | - | - | - | - | - | - | - | - | - | - | - |
Females |
||||||||||||||||||
Hunched posture | - | - | - | x | - | - | - | - | - | - | - | - | - | - | - | - | - | - |
Ruffled fur | - | x | x | x | x | x | x | x | x | x | x | x | x | - | - | - | - | - |
Diarrhea | - | x | x | x | x | - | - | - | - | - | - | - | - | - | - | - | - | - |
X = sign observed
- = observation performed, sign not observed
Test day | 1 | 1 | 1 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | ||
Time after treatment (hrs) | 1 | 2 | 3 | 5 | ||||||||||||||||
Animal N. | Sign | (G) | ||||||||||||||||||
1M | Ruffled fur | (3) | - | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | - | - | - | - | - | - | - | - |
Diarrhea | (1) | - | 1 | 1 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
2M | Ruffled fur | (3) | - | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | - | - | - | - | - | - | - |
Diarrhea | (1) | - | 1 | 1 | 1 | 1 | - | - | - | - | - | - | - | - | - | - | - | - | - | |
3M | Ruffled fur | (3) | - | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | - | - | - | - |
Diarrhea | (1) | - | 1 | 1 | 1 | 1 | - | - | - | - | - | - | - | - | - | - | - | - | - | |
4M | Behaviour sedated | (3) | - | - | - | 1 | - | - | - | - | - | - | - | - | - | - | - | - | - | - |
Hunched posture | (1) | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | - | - | - | - | - | - | - | - | - | |
Ruffled fur | (3) | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | - | - | - | - | - | - | - | - | |
Diarrhea | (1) | - | 1 | 1 | 1 | 1 | - | - | - | - | - | - | - | - | - | - | - | - | - | |
5M | Ruffled fur | (3) | - | 1 | 1 | 1 | - | - | - | - | - | - | - | - | - | - | - | - | - | - |
Diarrhea | (1) | - | 1 | 1 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
6F | Ruffled fur | (3) | - | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | - | - | - | - | - | - | - |
Diarrhea | (1) | - | 1 | 1 | 1 | 1 | - | - | - | - | - | - | - | - | - | - | - | - | - | |
7F | Ruffled fur | (3) | - | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | - | - | - | - | - | - | - | - |
Diarrhea | (1) | - | 1 | 1 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |
8F | Ruffled fur | (3) | - | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | - | - | - | - |
Diarrhea | (1) | - | 1 | 1 | 1 | 1 | - | - | - | - | - | - | - | - | - | - | - | - | - | |
9F | Hunched posture | (1) | - | - | - | 1 | - | - | - | - | - | - | - | - | - | - | - | - | - | - |
Ruffled fur | (3) | - | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | - | - | - | - | - | - | - | - | |
Diarrhea | (1) | - | 1 | 1 | 1 | 1 | - | - | - | - | - | - | - | - | - | - | - | - | - | |
10F | Ruffled fur | (3) | - | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | - | - | - | - | - | - | - |
Diarrhea | (1) | - | 1 | 1 | 1 | 1 | - | - | - | - | - | - | - | - | - | - | - | - | - |
- = observation performed, sign not observed
(G) = max. grade
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified, according to the CLP Regulation (EC) No 1272/2008
- Conclusions:
- LD50 (males and female) > 2000 mg/kg bw
- Executive summary:
The substance was assessed for its acute toxicity to rats in a limit test, according to the OECD guideline 401 and the EU Method B.1. The acqueous solution of the substance was administrated by oral gavage to five female and five male Wistar rats in a concentration of 2000 mg/kg bw. The rats were observed for mortality, clinical signs, macroscopic changes and vitality four times during test day 1 (at 1, 2, 3 and 5 hrs) and daily during days 2 - 15. The animals were weighed on test day 1 (pre-administration), day 8 and 15.
During the observation period, no mortality was observed and no macroscopical findings were noted. The body weight was increased. Clinical signs observed in some animals were sedated behaviour and hunched posture, while ruffled fur and diarrhea was observed in all animals until day 10 and day 2 respectively. No obvious macroscopical organ findings were seen in any animal.
Conclusion
LD50 (males and female) > 2000 mg/kg bw
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)