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Registration Dossier
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EC number: 201-398-0 | CAS number: 82-16-6
- 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
Key value for chemical safety assessment
Effects on fertility
Description of key information
An OECD 422 study is planned on Solvent Violet 36. The dossier will be updated as soon as the result becomes available.
Key information on Category members:
- Reinblau BLW: NOAEL for systemic toxicity and reproductive / developmental toxicity = 1000 mg/kg bw/day (OECD 422, GLP, K, rel.1)
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
An OECD 422 study will be performed on Solvent Violet 36 to support the Category approach. The dossier will be updated with the new study as soon at it becomes available.
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The study on Solvent green 28 - one of the category members - is GLP-compliant and of high quality Klimisch score =1). A new study will be conducted on Solvent Violet 36.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
There was no fertility study with Solvent Violet 36.
The following studies are available for category members:
1/ Solvent Green 28 (CAS 4851-50-7): In an OECD guideline 422 study (Combined Repeated Dose Toxicity Study and Reproductive/ Developmental Toxicity Screening Study in the Crl:CD(SD) Rat by Oral Gavage Administration) Solvent Green 28 was administered to three groups of ten male and ten female rats by oral gavage administration, for approximately 6 weeks (males) and up to eight weeks (females) (including a two week pre-pairing phase, pairing, gestation and early lactation for females), at dose levels of 100, 300 and 1000 mg/kg bw/day. A similarly constituted control group received the vehicle, corn oil, at the same volume dose as the treated groups.
The no-observed adverse-effect level (NOAEL) of Solvent Green 28 for systemic toxicity was considered to be 1000 mg/kg bw/day and the no-observed adverse-effect level (NOAEL) of Solvent green 28 for reproductive/developmental toxicity was also considered to be 1000 mg/kg bw/day.
2/ Solvent Blue 104 (Source : ECHA disseminated dossier) :
An OECD test guideline (OECD 421) and GLP-compliant Reproduction/Developmental Toxicity Screening Test was performed with the test item (Solvent Blue 104). Groups of 10 male and 10 female Wistar rats received doses of 0, 100, 300 and 1000 mg/kg bw by daily gavage. No toxicologically significant changes were noted in any of the parameters investigated in this study.
An NOAEL for general toxicity of 1000 mg/kg/day was established. No test item-related effects were observed in males or females up to and including 1000 mg/kg bw/day, the highest dose level administered.
An NOAEL for reproduction and development of 1000 mg/kg/day was established. No test item-related effects on reproduction or development were observed up to and including 1000 mg/kg bw/day, the highest dose level administered.
Conclusion:
The available two screening tests for reproductive toxicity and development toxicity consistently show no toxicity of the anthraquinone dye group; up to the limit dose no adverse effects are reported, and it can be concluded that “no hazard” is identified in any of these studies.
Effects on developmental toxicity
Description of key information
There was no developmental toxicity study with Solvent Violet.
Key information on Reinblau BLW (category member) Developmental toxicity: via oral route: NOAEL = 1000 mg/kg bw/day (OECD 414, GLP, K, Rel. 1)
Link to relevant study records
- 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 the Category dossier). - 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
- 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.
- 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
- Key result
- Abnormalities:
- no effects observed
- 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
- 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
- Key result
- Abnormalities:
- no effects observed
- Key result
- Developmental effects observed:
- no
- 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.
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The available study on Reinblau RLW - one of the category member - is GLP-compliant and of high quality (Klimisch score = 1)
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
no data
Toxicity to reproduction: other studies
Additional information
A developmental toxicity study according to OECD TG 414 was conducted with Reinblau RLW (one of the category members) in rats. Test stubstance was administered during the organogenesis and fetal growth phases of pregnancy in the Sprague Dawley CD rat. One group of 22 females received Reinblau RLW 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 bw/day from Day 6 to 19 after mating. A similarly constituted Control group received the vehicle alone. 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.
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 Reinblau RLW for maternal toxicity and embryo-fetal development was the limit dose of 1000 mg/kg bw/day.
Justification for classification or non-classification
Harmonised classification:
The substance has no harmonised classification according to the Regulation (EC) No. 1272/2008 (CLP).
Self-classification:
None of the category members is classifed for reproductive or developmental toxicity. An OECD 422 study is planned on Solvent Violet 36. The dossier will be updated as soon as the new study becomes available.
Additional information
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.
