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EC number: 269-505-3 | CAS number: 68259-02-9
- 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
Reactive Black 039 was found to have an oral LD50 >5000 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:
- From 17 September, 1992 to 08 October, 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- Principles of method if other than guideline:
- Guidelines followed
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: HanIbm: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: and BRL, Biological Research Laboratories, Ltd. Wolferstrasse 4, CH-4414 Füllinsdorf
- Age at study initiation: males: 8 weeks; females: 10 weeks
- Weight at study initiation: males: 190-205 g; females: 172-182 g
- Housing: Groups of five in Makrolon type-3 cages (size: 22 x 37.5 x 15 cm) with standard (softwood bedding ("Lignocel" , Schill AG, CH-4132 Muttenz).
- Diet: Pelleted standard Kliba 343, Batch 88/92 rat maintenance diet ("Kliba". Klingentalmuehle AG. CH-4303 Kaiseraugst) (ad libitum except for overnight fasting period)
- Water: Community tap water ad libitum
- Acclimation period: One week under laboratory conditions, after veterinary examination. Only animals without any visual signs of illness were used for the study.
- Identification: by unique cage number and corresponding color-coded spots on the tail
- Randomization: Randomly selected at time of delivery in groups of five.
- Fasting period before study: 16 to 17 h
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 40-70 %
- Air changes: 10-15 air changes/h
- Photoperiod: 12 h/12 h (music during the light period)
IN-LIFE DATES: From: September 17, 1992; To: October 8, 1992 - Route of administration:
- oral: gavage
- Vehicle:
- other: bidistilled water
- Details on oral exposure:
- TEST SUBSTANCE PREPARATION
The test substance was placed into a glass beaker on a tared Mettler PM 480 balance, and the vehicle (bidistilled water) was added. A w/v dilution was prepared using a homogenizer. Homogeneity of the test substance in the vehicle was maintained during treatment using a magnetic stirrer. The preparation was made immediately prior to each dosing.
Application Volume/kg bw: 10 mL at 2000 mg/kg bw - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 15 d
- Necropsy of survivors performed: yes; all animals were necropsied. All animals were euthanized by intraperitoneal injection of sodium pentobarbitone.
- Other examinations performed: clinical signs, body weight
- Mortality/Viability: Four times during test Day 1 (according to the laboratories SOP's the last check was conducted 5 h after application), and daily during Days 2-15.
- Body Weights: Test Days 1 (pre-administration), 8 and 15.
- Clinical Signs: 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 clinical signs. - Statistics:
- The LOGIT-Model could not be applied to the observed rates of death. The toxicity was estimated without use of a statistical model.
- Preliminary study:
- No data
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Remarks on result:
- other: other details not available
- Mortality:
- No premature death occurred.
- Clinical signs:
- other: Sedation and ruffled fur were observed in all treated animals between 24 h and 4 d after administration of test substance.
- Gross pathology:
- No macroscopic findings were observed.
- Other findings:
- No data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 of the test substance was found to be >2000 mg/kg bw in rats.
- Executive summary:
A study was conducted to assess the acute oral toxicity of the test substance (of 100 % purity) in HanIbm: WIST (SPF) rats according to OECD Guideline 401and EU Method B.1 in compliance with GLP.
Groups of 10 fasted animals (5/sex/dose) received a single oral (gavage) dose of 2000 mg/kg bw of the test substance. Parameters assessed included mortality, clinical observations, body weight and necropsy findings in all animals after a 15 d observation period.
No mortality occurred and no significant macroscopic abnormalities were seen at necropsy. Further, there were no effect on body weight gain. However, sedation and ruffled fur were observed in all treated animals between 24 h and 4 d after dosing.
Under the study conditions, the oral LD50 of the test substance was found to be >2000 mg/kg bw in rats.
Reference
None
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
Acute toxicity – oral
The Key study was conducted to assess the acute oral toxicity of the test substance in Wistar rats according to OECD Guideline 401 and EU Method B.1 in compliance with GLP.
Groups of 10 fasted animals (5/sex/dose) received a single oral (gavage) dose of 2000 mg/kg bw of the test substance. Parameters assessed included mortality, clinical observations, body weight and necropsy findings in all animals after a 15 d observation period.
No mortality occurred and no significant macroscopic abnormalities were seen at necropsy. Further, there were no effect on body weight gain. However, sedation and ruffled fur were observed in all treated animals between 24 h and 4 d after dosing. Under the study conditions, the oral LD50 of the test substance was found to be > 2000 mg/kg bw in rats.
Couple of more studies conducted to assess the acute oral toxicity of the test substance in rats found the oral LD50 of the test substance to be > 5000 mg/kg bw.
Based on the data of all the three studies it can be concluded that, Reactive Black 039 is considered to have low toxicity by oral route.
Further analysis of our substance does not indicate any harm upon oral exposure and neither the chemical structure of the substance nor any toxicokinetic results raise any concern about the toxic behavior of the substance upon dermal absorption, we will not perform any test on this endpoint in in vitro or in vivo test systems.
Acute toxicity – inhalation
Based on Column 2 of the table given in REACH Annex VIII, the study
on acute inhalation toxicity only needs to be conducted if an exposure
via inhalation is to be expected, based on vapour pressure and/or the
likelihood of an exposure to aerosols, particles or droplets. Referring
to the very low vapour pressure of the substance, the fact that the
substance is imported into the EU in a formulated form as a dust-free
powder or as a granulate, the inhalation route of exposure is considered
to be unlikely, thus the study on acute inhalation toxicity is being
waived.
Acute toxicity – dermal
The
substance FAT40171 has been tested for acute oral toxicity and has been
found to be not toxic to the animals investigated LD50 (males/females)
>2000 mg/kg bw. None of the animals died and none of the animals exhibit
any notable signs of toxicity. In addition, in animal tests on skin
irritation/corrosion effects the test substance has not been found to
cause severe irritating or corrosive effects to the skin or any other
effect resulting in a destruction of an intact skin barrier. In
addition, old tests on skin irritation performed on abraded skin areas
of animals resulting in a partial destruction of the skin barrier, also
no signs of toxicity were noted. The substance itself is characterized
as a dry powdery substance which is marketed in a dedusted form or in a
liquid mixture only. The molecular weight of the substance is 1021.1629
g/mole. From basic research on internal and external barriers of humans
it is known, that such molecules are almost not able to permeate the
skin resulting in an enhanced bioavailability of the substance applied
topically. Experts from the chemical industry, CRO s and regulatory
authorities, together with the NC 3Rs, have published a review paper
highlighting opportunity to waive requirements for acute toxicity
testing of non-pharmaceutical chemicals. The review focuses on acute
oral, dermal and inhalation toxicity, skin and eye irritation and skin
sensitisation. The paper, which is published as an open access article
in Critical Reviews in Toxicology, is intended to provide a focused
review for the regulatory community to use when considering the need to
generate acute toxicity data. Analysis presented in the paper
demonstrates that for pesticide active substances and general chemicals,
acute dermal toxicity testing very rarely provides information of value
for hazard identification or classification and labelling purposes, when
an acute oral study has already been conducted. Only 1 out of 438
chemical substances and 2 out of 240 active pesticide substances have
been found to be more severe than after oral application. These findings
suggest that acute dermal toxicity studies should not be performed
except in exceptional circumstances, for example where information on
absorption, toxicokinetics or mode of action suggests that acute
toxicity might be greater by the dermal rather than oral route. Since
analysis of our substance does not indicate any harm upon oral exposure
and neither the chemical structure of the substance nor any
toxicokinetic results raise any concern about the toxic behaviour of the
substance upon dermal absorption, we will not perform any test on this
endpoint in in vitro or in vivo test systems.
Justification for classification or non-classification
Based on the available data, Reactive Black 039 does not warrant classification for acute toxicity as per the criteria of Regulation EC No. 1272/2008 (CLP).
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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