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EC number: 225-862-7 | CAS number: 5124-25-4
- 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 oral LD50 of the test substance was considered 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 28 July, 1993 to 11 August, 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- Adopted February 24, 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- December, 1992
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- TEerasil Yellow GWL crude moist (FAT 36'014/F)
- 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. Wolferstrasse 4, CH-4414 Fullinsdorf, Switzerland
- Age at study initiation: Approx. 10 weeks
- Weight at study initiation: Males : 231 - 268 g; Females: 168 - 192 g
- Fasting period before study: 16 to 22 h (access to water was not interrupted). Food was presented approx. 3 to 4 h after dosing
- Housing: Group housing of 5 animals/sex/cage in labelled polycarbonate cages containing purified sawdust as bedding material (Woody SPF, supplied by B.M.I., Helmond, The Netherlands)
- Diet: Standard pelleted laboratory animal diet (Kliba 343 from Klingentalmühle Ag, Kaiseraugst, Switzerland) (free access, except for overnight fasting period)
- Water: Tap-water (Free access)
- Acclimation period: At least one week
- Identification: By individual earmark.
- Randomisation: Randomly selected at time of delivery in groups of five.
ENVIRONMENTAL CONDITIONS
- Temperature: 21 °C
- Humidity: 55 %
- Air changes: 15 air changes/h
- Photoperiod: 12 h/12 h (music during light period) - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 1%
- Details on oral exposure:
- Test substance preparation:
The test substance was placed into a glass beaker on a tared Mettler analytical balance and carboxymethyl cellulose 1 % was added. A weight/weight suspension was prepared using a magnetic stirrer, a mechanical stirrer and an electric blender. The preparation was made immediately prior to each dosing.
Dose volume: 10 mL/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
Other examinations performed: clinical signs, body weight,
- Mortality / Viability: At least three times each Day.
- Body Weights: Test Days 1 (pre-administration), 8 and 15
- Clinical Signs: Each animal was examined for changes to treatment with particular attention paid to changes in behaviour, respiration, motility, body posture, motor susceptibility, skin, eyes, nose and fur. Observations were performed four times during Day 1, and once daily during Days 2 - 15. All abnormalities were recorded.
- Necropsy of survivors performed: yes; all animals were necropsied. All animals surviving to the end of the observation period were sacrificed by oxygen/carbon dioxide asphyxiation. - Statistics:
- No data
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 1 814 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: No clinical signs of ill health or behavioural changes were observed during the study period.
- Gross pathology:
- Macroscopic post mortem examination of the animals at termination did not reveal any significant abnormalities. Renal pelvic dilation, observed in 1/10 treated animals, is a common finding in animals of this age and strain and therefore considered of no toxicological significance.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 of the test substance was found to be >2000 mg/kg bw (i.e. ca. >1814 mg a.i./kg bw) in rats.
- Executive summary:
A study was conducted to assess the acute oral toxicity of the test substance (of 90.7 % purity) in Wistar rats according to OECD Guideline 401 and EU Method B.1 in compliance with GLP. A group of 5 female and 5 male rats received a single oral (gavage) dose of 2000 mg/kg bw of test substance. Parameters assessed included mortality, clinical observations, body weight and necropsy findings in all animals over a 15 d observation period. No mortality and no clinical signs were observed and no significant macroscopic abnormalities were seen at necropsy except renal pelvic dilation, observed in a single male, which is a common finding in animals of this age and strain and was therefore considered to be of no toxicological significance. Further, normal body weight gain was noted in all females over the first week. However, slightly reduced body weight gain was observed among females over Week 2 compared to Week 1. Taking the above findings into account, the oral LD50 of the test substance was >2000 mg/kg bw (i.e. ca. >1814 mg a.i./kg bw) in rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Good Quality Study
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Oral:
In the key study conducted in Wistar rats according to OECD Guideline 401 and EU Method B., no mortality or clinical signs were seen when FAT 36014/F was administered to a group of rats containing 5 males and 5 females at 2000 mg/kg bw via gavage. Hence, the oral LD50 of the test substance was found to be considered to be >2000 mg/kg bw (i.e. ca. >1814 mg a.i./kg bw) in rats. A few mores single dose studies with oral gavage of test substance FAT 36014 at doses up to 15000 mg/kg bw are available. These studies showed that FAT 36014 has a very low toxicity with an oral LD50 >15000 mg/kg bw.
Inhalation:
Currently no study to assess the acute inhalation toxicity potential of Disperse Yellow 042 is available. However, the vapour pressure for the substance can be considered low owing to the high melting point (>308 °C). Hence the substance is considered to have low volatility. Based on column 2, ‘Specific rules for adaptation from column 1’ of the table given in REACH Annex VII, 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 expected low volatility 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 exposure via inhalation is considered to be unlikely. Further, the chemical was found to have low acute toxicity when tested via oral route with no mortality when tested up to 5000 mg/kg bw. Hence, considering all the above arguments, it is considered that Disperse Yellow 042 has a low toxicity potential via inhalation route and thus the study on acute inhalation toxicity is considered scientifically not necessary.
Dermal:
Currently no study to assess acute dermal toxicity of Disperse Yellow 042 is available. However, the molecular weight of the chemical is 369.4 g/mol, indicating it being large for dermal absorption. Hence, the dermal uptake for the chemical is expected to be limited. The chemical showed low toxicity potential in the available acute oral toxicity studies (LD50 >5000 mg/kg bw), with no mortality or systemic toxicity being seen upto 2000 mg/kg bw, hence it does not need to be classified STOT SE. Similarly, absence of systemic toxicity in skin irritation as well as sensitization studies, further supports the conclusion that no adverse effects are expected for the chemical via the dermal route. Further, experience with similar chemical substances has demonstrated that it is very unlikely that toxicity related to the intrinsic properties of the chemical only show up upon dermal exposure and not after systemic application. Hence, low toxicity is expected on acute dermal exposure of Disperse Yellow 042 and testing by the dermal route was considered scientifically not necessary.
Justification for classification or non-classification
Low toxicity was seen in the acute oral toxicity studies with Disperse Yellow 042 with LD50 being >2000 mg/kg bw, hence the substance does not warrant classification for acute toxicity as per the criteria of Regulation (EC) No. 1272/2008.
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