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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 222-838-8 | CAS number: 3626-36-6
- 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
NOAEL > 1000 mg/kg bw/day at 30 days
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- other: read across from similar substance
- Adequacy of study:
- key study
- Study period:
- From january 15 to february 28, 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study not performed under GLP.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 1000 mg/kg/day of the substance where administrated daily (5 times a week) by gavage over a period of 30 days to male and female rats.
- GLP compliance:
- no
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Tif: RAIf (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Age at study initiation: 4 weeks- Weight at study initiation: 128-129 g, female; 113-115 g males- Housing: the animals were housed individually in Macrolon cages type 3 with standardized granulated soft wood bedding (Socicté Parisicnne des sciures Pantin). - Diet: Pelleted standard diet (Nafag. No. /890) ad LibitumNeither insecticides nor chemicals were applied in the animal room with the exceptic of a desinfectant: Fungitex SB (Prod. Nr. 30071, Ciba-Geigy).ENVIRONMENTAL CONDITIONS- Temperature (°C): 22 ± 1°C- Humidity (%): 55 ± 5%- Air changes (per hr): 15-17- Photoperiod (hrs dark / hrs light): 10/10
- Route of administration:
- oral: gavage
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:Volume: 10 ml/kg of a daily prepared suspension (10 % compound in Carboxymethyl-cellulose 2 %)The animals of group 1 (Control) received a similar treatment with CMC 2 % without the compound.
- Duration of treatment / exposure:
- 4 weeks and 2 days of the 5th week (30 days)
- Frequency of treatment:
- 5 times at week (in total 22 doses); 1 dose per day for 4 weeks plus in the 5th week on Monday to Tuesday
- Remarks:
- Doses / Concentrations:0/1000Basis:no data
- No. of animals per sex per dose:
- 20 males, 20 females per experimental group
- Control animals:
- yes, concurrent vehicle
- Observations and examinations performed and frequency:
- MORTALITY: Yes, dailySYMPTOMS: Yes, dailyBODY WEIGHT: Yes, weeklyFOOD CONSUMPTION: Yes, weeklyEYE EXAMINATION: Yes, by observation prior to dosing and after the treatment periodHEARING TEST: prior to dosing and after the treatment period (by hand clapping)MEAN FOOD CONSERVATION: was calculated according the following formula: MFC = (weekly food consumption in g / midweek body weight) x (1000/7)Haematologic, blood chemistry and urinalysis measurements were carried out by standard methods on 20 randomized rats (5 males, 5 females per group) from the control and one test group at test day 28.To reduce the biologic variability due to circadian rhythms, blood sampling for haematology and blood chemistry was between the hours of 8.00 and 9.00 a.m. For blood chemistry measurements food was withheld overnight prior to blood removal. The site of blood removal was the orbital sinus and a micro-haematocrit glass capillary tube was used.Blood samples from each animal with the respective anticoagulant (EDTA for performing haematologleal and heparin for blood chemistr measurements) were aliquoted into individual vials. No anaesthesia was used to restrain the animals. All blood collection was by manual restraint only. Urine for analysis was collected overnight. The individual rats were housed in special metabolism cages. Food and water was withheld during the time of urine collection.The quantitative assay of all blood parameters was completed within a 8 h. period under "Quality Control" conditions.
- Statistics:
- For each time point and parameter a uni-variate statistical analysis was conducted. Due to the routine manner of the analysis system parameter free methods were applied. The treated group was compared to the control group in respect of dispersion and displacement.
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- Comparable to the controls
- Food efficiency:
- no effects observed
- Description (incidence and severity):
- Comparable to the controls
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- Unremarkable
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- Unremarkable and comparable to those of the controls
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- Unremarkable
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- No statistically significant
- Details on results:
- During the experiment no treatment realted reactions were observed with respect to clinical symptoms, mortality, food consumption, body weight, clinacl laboratory investigations and pathology.Eye examination did not reveal any ocular changes. No loss hearing ability was registred. At the end of the 30 day toxicity study or after an additional recovery period of two weeks the treated rats showed neither macroscopical nor microscepical changes which could be related to the treatment with FAT 11 11o/N.
- Dose descriptor:
- NOEL
- Effect level:
- > 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- mortality
- Remarks on result:
- other: valid test
- Critical effects observed:
- not specified
- Conclusions:
- It can be concluded from the observations made during the study that 1000 mg/kg/day of the tested substance produced no observable effects in male and female rats when administrated daily by gavage over a period of 30 days.
- Executive summary:
The toxicity of the tested substance was investigated during a period over 30 day on females and males rats by oral administration.
No observable effects were observed at a dosage of 1000 mg/kg/day.
Reference
Macroscopical Findings:
All details regarding the gross anatomical changes are listed within the macroscopical findings in individual rats. No compound related gross anatomical changes were noted.
Microscopical Findings:
All details regarding the histopathological changes are listed within the microscopical findings in individual rats. All minor changes seen in some control and treated rats and described within the microscopical findings in individual rats were only incidental in nature and not related to the treatment with FAT 11 110/N.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Some of the available tests respectively at 28 and 30 days, don't report a limit dose for the tested substance 01 but identify No-Observed-Adverse-Effect-Level (NOAEL) as > 1000 mg/kg. In the other study on similar substances, no toxic effects were observed.
The key value chose was the NOAEL > 1000 mg/g.Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Subacute study (30 days) on similar substance 01 of which results have been confirmed in the Leist et al. 1982 study.
Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
Based on REACH regulation annex VIII column 2 (specific rules for adaptation from column 1) the study does not need to be conducted if exposure of humans via inhalation is unlikely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.
Justification for selection of repeated dose toxicity inhalation - local effects endpoint:
Based on REACH regulation annex VIII column 2 (specific rules for adaptation from column 1) the study does not need to be conducted if exposure of humans via inhalation is unlikely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.
Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
Based on REACH regulation annex VIII column 2 (specific rules for adaptation from column 1) the study does not need to be conducted if exposure of humans by dermal route is unlikely; physicochemical and toxicological properties don't suggest potential for a significant rate of absorption through the skin
Justification for selection of repeated dose toxicity dermal - local effects endpoint:
Based on REACH regulation annex VIII column 2 (specific rules for adaptation from column 1) the study does not need to be conducted if exposure of humans by dermal route is unlikely; physicochemical and toxicological properties don't suggest potential for a significant rate of absorption through the skin
Justification for classification or non-classification
According to CLP regulation (EC1272/2008) Direct Orange 26 is not classified for subacute toxicity.
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.