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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 286-122-7 | CAS number: 85187-33-3
- 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 test substance is not toxic in an acute oral, inhalation and dermal toxicity studies.
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:
- 3 February 1994 to 6 April 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- None
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: P.04.36
- Expiration date of the lot/batch: November, 1998
- Test article:: FAT 40066/C
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature - Species:
- rat
- Strain:
- other: Tif: RAI f (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Limited Animal Production 4332 Stein / Switzerland
- Weight at study initiation: 200 to 246 g
- Fasting period before study: overnight
- Housing: Macrolon cages type 4, with standardized soft wood bedding \
- Diet: rat diet (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland)) ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour/day light cycle - Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- distilled water
- Details on oral exposure:
- Administration of the test arrticle: one single oral dose, by gastric intubation (gavage)
Volume applied: 10 ml/kg body weight - Doses:
- 2000 mg/kg (males and females)
- No. of animals per sex per dose:
- 10 animals
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology - Preliminary study:
- None
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities occurred in this study.
- Clinical signs:
- other: Piloerection, hunched posture and dyspnea were seen, being common symptoms in acute tests. The animals recovered within 1 to 2 days.
- Gross pathology:
- At necropsy, no deviations from normal morphology were found in all animals.
- Other findings:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of FAT 40066/C in rats is greater than 2000 mg/kg bw.
- Executive summary:
The acute oral toxicity of FAT 40066/C was investigated in an an OECD 401 guideline test according to GLP. The test substance was investigated on 10 rats in total. A single dose of 2000 mg/kg bw orally was tested according to OECD guideline 401 and EU method B.1. After administration of the compound, the animals were observed for 14 days. Deaths and clinical symptoms were recorded. At the end of the observation period, surviving animals were killed by exsanguination under ether anaesthesia and an autopsy was performed. Piloerection, hunched posture and dyspnoea were seen, being common symptoms in acute tests but the animals recovered within 1 to 2 days. At necropsy, no deviations from normal morphology were found in all animals. In conclusion, the acute oral LD50 of FAT 40066/C in rats of both sexes observed over a period of 14 days is greater than 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- OECD guideline and GLP compliant study.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 June 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Principles of method if other than guideline:
- None
- GLP compliance:
- no
- Test type:
- traditional method
- Limit test:
- no
- Specific details on test material used for the study:
- Lanasol Red 6G, Product No. 01-146394-100-0, Batch No. (DCT No. 8-0053) 78316/11
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 247 and 345 g
- Fasting period before study: 1 hour
- Housing: housed, individually, in suspended, wire bottom cages
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 74 ± 1
- Humidity (%): 45 to 55
- Photoperiod (hrs dark / hrs light): 12 hours - Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- not specified
- Vehicle:
- air
- Remark on MMAD/GSD:
- None
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: 3-neck, round-bottom, 250 ml Pyrex flask
- Source and rate of air: 0.5 liter of air per minute per rat.
- Duration of exposure:
- 4 h
- Remarks on duration:
- None
- Concentrations:
- The average analytical concentration obtained was 0.42 ± 0.32 mg/L.
- No. of animals per sex per dose:
- None
- Control animals:
- not specified
- Details on study design:
- None
- Statistics:
- None
- Preliminary study:
- None
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 0.42 mg/L air (nominal)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: The concentration stated above was the maximum attainable aerosol concentration of the test material under the experimental conditions
- Mortality:
- No mortality observed.
- Clinical signs:
- other: Abnormal exposure at 3 to 4 h of exposure and upto 4 h post exposure in all animals. No abnormalities were noted during the 14-day post-exposure period.
- Body weight:
- No effects observed.
- Gross pathology:
- Gross pathological observations showed organs of all animals to be within normal limits.
- Other findings:
- No effects observed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LC50 of test substance was 0.42 ± 0.32 mg/l and was found to be non toxic via inhalation.
- Executive summary:
An acute toxicity study via inhalation was performed in 10 laboratory rats (5 males & 5 females) initially weighing between 247 and 345 grams, for 4 hours via the inhalation route at an atmospheric concentration of 0.42 ± 0.32 mg/l, exhibited abnormal respiration for the last half of the exposure. This condition persisted for approximately 4 hours post-exposure. The test substance was generated as a dust using a 3-neck, round-bottom, 250 ml Pyrex flask. No abnormalities were noted during the 14-day post-exposure period. There was no mortality seen. No abnormalities were noted during the 14-day post-exposure period except abnormal exposure at 3 to 4 h of exposure and up to 4 h post exposure in all animals which was subsided from Day1 of observation period. Gross pathological observations showed organs of all animals to be within normal limits. The concentration stated above was the maximum attainable aerosol concentration of the test material under the experimental conditions. The average mass median particle diameter was 3.90 ± 0.44 µm. Gross pathological observations showed organs of all animals to be within normal limits. Based on the study results the LC50 of test substance (FAT 40066) was 0.42 ± 0.32 mg/l.
Reference
The average mass median diameter of particles for the 4-hour exposure was 3.90 ± 0.44 µm. Abnormal respiration was noted during the last 2 hours of the 4-hour exposure for all animals. This condition persisted for the first 4 hours post-exposure; however, all animals appeared to be normal for the remainder of the post-exposure period. Abnormal exposure at 3 to 4 h of exposure and up to 4 h post exposure in all animals.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- klimisch score 2
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:
- 10 May 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- None
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- 'Lanasol Red 6G, Product #01- 146394- 100-0, Batch No. 78316/11 (DCT No. 8-0053), brownish-red powder
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals, Boyertown, Pennsylvania
- Weight at study initiation: 2.3 and 3.0 kgs
- Diet: ad libitum
- Water: ad libitum
- Type of coverage:
- occlusive
- Vehicle:
- water
- Remarks:
- warm
- Details on dermal exposure:
- 24 hours prior to dosing, the animals were immobilized in an animal holder and their backs clipped free of hair with an Oster animal clipper exposing approximately 30 % of each animal's skin surface. Immediately prior to dosing, one-half of the animals were further prepared by making epidermal abrasions longitudinally over the area of exposure. The abrasions were made sufficiently deep to penetrate the stratum corneum, but not deep enough to disturb the derma. The test material was applied, in the quantity of 3 g/kg of body weight, to the test area and held in contact with the skin by means of an elastic sleeve for a period of 24 hours at which time the sleeve was removed and the treated areas washed clean of the remaining excess test material with warm water. The animals were then returned to their individual cages and observed for toxic signs and survival.
- Duration of exposure:
- 24 hours
- Doses:
- 3 gm/kg of body weight
- No. of animals per sex per dose:
- 6 animals per dose
- Control animals:
- not specified
- Preliminary study:
- None
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 3 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality observed.
- Clinical signs:
- other: There were no adverse clinical signs observed in any of the six animals throughout the study. There was skin reaction seen during the study, all animals exhibited edema and erythema for 3 days. At day 4, six animals displayed erythema and four animals dis
- Gross pathology:
- Necropsies revealed all organs to be within normal limits
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Acute dermal median lethal dose (LD50) of FAT 40066 was >3000 mg/kg and was found to be non toxic via dermal route of administration.
- Executive summary:
A acute toxicity study via dermal route was performed on New Zealand albino. The test material was applied, in the quantity of 3000 mg/kg of body weight, to the test area and held in contact with the skin by means of an elastic sleeve for a period of 24 hours at which time the sleeve was removed and the treated areas washed clean of the remaining excess test material with warm water. Six animals were used in the study. There were no mortality observed. There were no adverse clinical signs observed in any of the six animals throughout the study. There was skin reaction seen during the study, all animals exhibited edema and erythema for 3 days. At day 4, six animals displayed erythema and four animals displayed edema. This lasted until day 7, when the only irritation present was edema on two animals. By day 8, all animals were normal and remained so throughout the study. All gross necropsies were within limits. Based on the findings, an acute dermal median lethal dose (LD50) of FAT 40066 was >3000 mg/kg and was found to be non toxic via dermal route of administration.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 000 mg/kg bw
- Quality of whole database:
- klimisch score 2
Additional information
Acute Oral Toxicity:
The acute oral toxicity of FAT 40066/C was investigated in an an OECD 401 guideline test according to GLP. The test substance was investigated on 10 rats in total. A single dose of 2000 mg/kg bw orally was tested according to OECD guideline 401 and EU method B.1. After administration of the compound, the animals were observed for 14 days. Deaths and clinical symptoms were recorded. At the end of the observation period, surviving animals were killed by exsanguination under ether anaesthesia and an autopsy was performed. Piloerection, hunched posture and dyspnoea were seen, being common symptoms in acute tests but the animals recovered within 1 to 2 days. At necropsy, no deviations from normal morphology were found in all animals. In conclusion, the acute oral LD50 of FAT 40066/C in rats of both sexes observed over a period of 14 days is greater than 2000 mg/kg bw. In another study, an acute oral toxicity study with FAT 40066/A was carried out in Tif RAI male and female rats (5/sex/dosage) at the dose concentration of 4640, 6000 and 7750 mg/kg. A 30 % concentration as formulation was used. All animals were observed for mortality, clinical signs, body weight and gross pathology. One female animal each on day 7 and day 14 died from the 7750 mg/kg dose group. All animals from 4640 and 6000 mg/kg dose group survived. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. The surviving animals had recovered within 8 to 11. days. No substance related gross organ changes were seen. Based on the study results, the acute oral median lethal dose (LD50) of FAT 40066/A in rats of both sexes observed, over a period of 14 days is greater than 7700 mg/kg.
Acute Inhalation Toxicity:
An acute toxicity study via inhalation was performed in 10 laboratory rats (5 males & 5 females) initially weighing between 247 and 345 grams, for 4 hours via the inhalation route at an atmospheric concentration of 0.42 +/- 0.32 mg/l, exhibited abnormal respiration for the last half of the exposure. This condition persisted for approximately 4 hours post-exposure. The test substance was generated as a dust using a 3-neck, round-bottom, 250 ml Pyrex flask. There was no mortality observed. No abnormalities were noted during the 14-day post-exposure period except abnormal exposure at 3 to 4 h of exposure and up to 4 h post exposure in all animals which was subsided from Day1 of observation period. Gross pathological observations showed organs of all animals to be within normal limits. The concentration stated above was the maximum attainable aerosol concentration of the test material under the experimental conditions. The average mass median particle diameter was 3.90±0.44µm. Based on the study results the LC50 of test substance was 0.42 ± 0.32 mg/l.
Acute Dermal Toxicity:
An acute toxicity study via dermal route was performed on New Zealand albino rabbits as per the method which is equivalent of OECD guideline 402. The test material was applied, in the quantity of 3000 mg/kg of body weight, to the test area and held in contact with the skin by means of an elastic sleeve for a period of 24 hours at which time the sleeve was removed and the treated areas washed clean of the remaining excess test material with warm water. Six animals were used in the study. There was no mortality observed. There were no adverse clinical signs observed in any of the six animals throughout the study. There was skin reaction seen during the study, all animals exhibited edema and erythema for 3 days. At day 4, six animals displayed erythema and four animals displayed edema. This lasted until day 7, when the only irritation present was edema on two animals. By day 8, all animals were normal and remained so throughout the study. All gross necropsies were within limits. Based on the findings, an acute dermal median lethal dose (LD50) of FAT 40066 was >3000 mg/kg and was found to be non toxic via dermal route of administration.
Justification for classification or non-classification
Based on the acute oral, inhalation and dermal toxicity studies, the test substance does not considered to be classified according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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.