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EC number: 225-443-9 | CAS number: 4851-50-7
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Justification for type of information:
- Justification Document for the Category of Six Anthraquinone Dyes
LANXESS Deutschland GmbH has registered five mono-constituent anthraquinone dyes of similar chemical structure using a category approach: Solvent Violet 36 (CAS No 82-16-6), Solvent Green 3 (CAS No 128-80-3), Reinblau RLW (CAS No 41611-76-1), Reinblau BLW (CAS No 32724-62-2) and Solvent Green 28 (CAS No 4851-50-7). Additional data were taken from another registered anthraquinone dye, Solvent Blue 104 (CAS No 116-75-6), leading to a category consisting of six members (see attached justification in Category dossier).
Data source
Materials and methods
Test material
- Reference substance name:
- 1,4-bis[[4-(1,1-dimethylethyl)phenyl]amino]-5,8-dihydroxyanthraquinone
- EC Number:
- 225-443-9
- EC Name:
- 1,4-bis[[4-(1,1-dimethylethyl)phenyl]amino]-5,8-dihydroxyanthraquinone
- Cas Number:
- 4851-50-7
- Molecular formula:
- C34H34N2O4
- IUPAC Name:
- 1,4-bis[(4-tert-butylphenyl)amino]-5,8-dihydroxy-9,10-dihydroanthracene-9,10-dione
Constituent 1
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- At 1000 mg/kg bw/day a total of 17 females were recorded with the clinical sign of blue staining of the tail. This was considered to be related to the blue coloured test material being excreted in the faeces. Two animals were recorded with abnormally coloured staining of the head and muzzle, where a further qualifier of colour was omitted in error, however these were recorded on Day 0 after mating, and therefore could not have been related to the test material. In addition four treated females (numbers 31,32, 33 and 34) were recorded with abnormal colouration of the tail on Day 20 after mating; however, no further qualifier of colour was recorded in error. Three out of the four of these females were confirmed as having a blue tail at necropsy on Day 20 after mating.
There were no other consistent clinical signs, nor any dosing signs, observed that were considered to be related to treatment at the limit dose of 1000 mg/kg bw/day. - Mortality:
- no mortality observed
- Description (incidence):
- There were no premature decedents.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Mean overall bodyweight gain during gestation was similar to controls and unaffected by treatment at 1000 mg/kg/day.
There were a number of incidences of slight but statistically significant differences in mean absolute body weight at 1000 mg/kg/day when compared to the Controls (approximately 3% on Days 6, 10, 11, 12, 16, 17, 18 of gestation), however, this was principally due to slightly lower gain experienced during Days 3 to 6 of gestation, prior to the commencement of treatment, such that mean bodyweight at the start of treatment was statistically significantly lower than Controls for females receiving 1000 mg/kg/day. After the commencement of treatment, mean body weight gain during Days 6-20 of gestation for treated females was not significantly different from Controls (Controls 113g; dose group 111g). - Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- Mean overall values of food consumption during Days 6-19 of gestation for females receiving 1000 mg/kg bw/day were no different from Controls and were unaffected by treatment.
Mean food consumption for treated females immediately prior to the commencement of treatment (during Days 3-5 of gestation) was marginally lower than Controls, attaining statistical significance, however, subsequent food consumption for the remainder of gestation was unaffected by treatment. - Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Endocrine findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- Mean gravid uterine weight was similar to Controls and unaffected by treatment and when mean values of body weight and body weight gain were adjusted for the contribution of the gravid uterus, the maternal portion of mean body weight gain during Days 6-20 of gestation was similar to Controls and unaffected by treatment at 1000 mg/kg bw/day.
- Gross pathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Several females receiving 1000 mg/kg bw/day showed blue colouration of gastro-intestinal content.
Three females at 1000 mg/kg bw/day showed blue colouration of the rectal tissue, 5 females showed blue coloration of the stomach tissue and 17 females were confirmed as having blue colouration of the tail.
The blue staining observed was considered discolouration caused by the test material itself (a blue dye) and is considered not to represent toxicity.
There were no other blue coloured organs observed in any female, and no further maternal findings observed at macroscopic examination that were considered to relate to treatment. - Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- no effects observed
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Description (incidence and severity):
- One Control female was found to be non-pregnant. All treated females were pregnant with a live litter on Day 20 of gestation.
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- no effects observed
- Changes in number of pregnant:
- no effects observed
- Other effects:
- no effects observed
- Details on maternal toxic effects:
- Embryo-fetal survival was clearly unaffected by treatment at 1000 mg/kg bw/day with mean numbers of implantations, resorptions, live young and percentages of sex ratio and pre and post-implantation loss being similar to Control values.
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- behaviour (functional findings)
- body weight and weight gain
- changes in number of pregnant
- changes in pregnancy duration
- clinical biochemistry
- clinical signs
- dead fetuses
- early or late resorptions
- effects on pregnancy duration
- gross pathology
- haematology
- histopathology: non-neoplastic
- maternal abnormalities
- mortality
- necropsy findings
- number of abortions
- organ weights and organ / body weight ratios
- pre and post implantation loss
- total litter losses by resorption
Maternal abnormalities
- Key result
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Mean male, female and overall fetal weights in litters of females receiving 1000 mg/kg bw/day were lower than Controls, and although statistical significance was attained, the difference was marginal (approximately 0.2g or 5-6% lighter than Controls) and considered not adverse since embryo-fetal survival and development were clearly unaffected by treatment.
Mean placental weights at 1000 mg/kg/day were similar to Controls and unaffected by treatment. - Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Anogenital distance of all rodent fetuses:
- not examined
- Changes in postnatal survival:
- not examined
- External malformations:
- no effects observed
- Description (incidence and severity):
- Fetal development was clearly unaffected by treatment at the limit dose of 1000 mg/kg bwday.
- Skeletal malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The incidence of major and minor abnormalities and skeletal variants showed no relationship to treatment.
At 1000 mg/kg bw/day there was a slightly increased incidence of delayed/ incomplete ossification/unossified thoracic vertebrae compared to concurrent control, however, this was within the Historical Control range. - Visceral malformations:
- no effects observed
- Other effects:
- no effects observed
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reduction in number of live offspring
- changes in sex ratio
- fetal/pup body weight changes
- changes in litter size and weights
- changes in postnatal survival
Fetal abnormalities
- Key result
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this embryo-fetal developmental toxicity study in rats, it was concluded that the No-Observed--Adverse-Effect-Level (NOAEL) of Macrolex Blau 3R for maternal toxicity was the limit dose of 1000 mg/kg bw/day.
For embryo-fetal development, the limit dose of 1000 mg/kg bw/day was considered to be the No-Observed-Adverse-Effect-Level (NOAEL), when administered during the organogenesis and fetal growth phases of gestation in the rat, as there was a marginal reduction in fetal weight which was considered not adverse due to there being no effect of treatment upon embryo-fetal survival or development. - Executive summary:
The objective of this study was to assess the influence of Macrolex Blau 3R, a blue powder, on embryo-fetal survival and development when administered during the organogenesis and fetal growth phases of pregnancy in the Sprague Dawley CD rat. The study was conducted according to the OECD TG 414 and in compliance with GLP.
One group of 22 females received Macrolex Blau 3R suspended in 0.5% CMC-Na solution at the limit dose of 1000 mg/kg bw/day by daily oral gavage administration at a dose volume of 10 mL/kg/day from Day 6 to 19 after mating. A similarly constituted Control group received the vehicle, according to the same dose volume and regimen. Animals were killed on Day 20 after mating for reproductive assessment and fetal examination.
Clinical observations, body weight and food consumption were recorded. Adult females were examined macroscopically at necropsy on Day 20 after mating with the weight of the gravid uterus recorded. All fetuses were weighed, subjected to an external macroscopic examination and then subsequently to detailed internal visceral or skeletal examination.
Treatment of pregnant female Sprague Dawley rats with Macrolex Blau 3R daily from Day 6 to Day 19 after mating, inclusive, at the limit dose of 1000 mg/kg bw/day was well tolerated and elicited no deaths and no toxicity related changes in clinical condition of the adult females.
At 1000 mg/kg bw/day a total of 17 females were recorded with the clinical sign of blue staining of the tail. At necropsy several females receiving 1000 mg/kg/day showed blue colouration of gastro-intestinal contents, three females showed blue colouration of rectal tissue, 5 females were recorded with blue coloration of stomach tissue and 17 females were confirmed as having blue colouration of the tail. The blue staining observed was considered discolouration caused by the test material itself (a blue dye) and is considered not to represent toxicity.
Body weight gain and food consumption during gestation were unaffected by treatment and there were no other maternal findings observed at macroscopic examination that were considered to relate to treatment.
There was no effect of treatment at 1000 mg/kg bw/day upon embryo-fetal survival or placental weights, and fetal development was also unaffected by treatment at this limit dose, with the incidence of major and minor abnormalities and skeletal variants showing no relationship to treatment.
Mean male, female and overall fetal weights at 1000 mg/kg bw/day were lower than Controls, but the difference was considered marginal (approx. 5-6%) and was clearly not adverse since embryo fetal survival and development were unaffected by treatment.
Based on the results of this embryo-fetal developmental toxicity study in rats, it was concluded that the No-Observed-Adverse- Effect-Level (NOAEL) of Macrolex Blau 3R for maternal toxicity and embryo-fetal development was the limit dose of 1000 mg/kg bw/day.
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