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EC number: 221-409-2 | CAS number: 3087-16-9
- 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:
- experimental study
- Adequacy of study:
- key study
- 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:
- Data is from peer reiviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Teratogenicity and embryotoxicity study of green s in rats
- Author:
- S. A. CLODE
- Year:
- 1 987
- Bibliographic source:
- Food Chemical Toxicology. Vol. 25, No. 12, pp. 995-997, 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD 422
- Principles of method if other than guideline:
- Combined repeated dose repro-devp. Screen of Green S (Hydrogen [4-[4-(dimethylamino)α-(2-hydroxy-3,6-disulphonato-1-naphthyl)benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium, monosodium salt) in rats
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Hydrogen [4-[4-(dimethylamino)-α-(2-hydroxy-3,6-disulphonato-1-naphthyl)benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium, monosodium salt
- EC Number:
- 221-409-2
- EC Name:
- Hydrogen [4-[4-(dimethylamino)-α-(2-hydroxy-3,6-disulphonato-1-naphthyl)benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium, monosodium salt
- Cas Number:
- 3087-16-9
- Molecular formula:
- C27H26N2O7S2.Na
- IUPAC Name:
- Hydrogen [4-[4-(dimethylamino)-α-(2-hydroxy-3,6-disulphonato-1-naphthyl)benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium, monosodium salt
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): Hydrogen [4-[4-(dimethylamino)-α-(2-hydroxy-3,6-disulphonato-1-naphthyl)benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium, monosodium salt
- Molecular formula :C27H26N2O7S2.Na
- Molecular weight: 576.623 g/mol
- Substance type:Organic
- Physical state:Solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Green S (Wool Green BS; CI (1971) No. 44090; EEC E.142, monosodium salt of 4,4'-bis(dimethylamino)-diphenylmethylene-2-naphthol-3,6-disulphonic acid, sodium 5-[4-dimethylamino-~-(4-dimethyliminocyclohexa - 2,5 - dienylidene)benzyl] - 6-hydroxy-7 sulphonatonaphthalene-2-sulphonate))
- Molecular formula (if other than submission substance): C27H26N2O7S2.Na
- Molecular weight (if other than submission substance): 576.6 g/mole
- Substance type: Organic
- Physical state: No data available
- Impurities (identity and concentrations): Dye 82% (80%); volatile matter, 3.37% (4.9%); water insoluble matter, 0.01% (0.07%); sodium chloride, 1.4% (2.6%); sodium sulphate, 8.5% (6.0%); pH (of a 1% solution in distilled water), 5.4 (2.9); lead, < 5 ppm; copper, 4 ppm (2 ppm); chromium, 6 ppm (8 ppm); zinc, 9 ppm (5 ppm); iron, 30 ppm (35 ppm); cadmium, < 1 ppm; mercury, 0.2 ppm (< I ppm); free aromatic amines (as aniline), 29 ppm (17 ppm); Michler's hydrol, <0.01% (<0.02%); Michler's ketone, < 0.01%; R-acid, 0.11% (0.05%); subsidiary dyes, < 1%; ether extractable material, 0.14%.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Specified-pathogen-free colony (Olac (1976) Ltd, Bicester, Oxon)
- Age at study initiation: No data available
- Weight at study initiation: No data available
- Fasting period before study: No data available
- Housing: Animals were housed in five per caged till 7 weeks and then individually.
- Diet (e.g. ad libitum): Spratt's Laboratory Diet No. 5, ad libitum
- Water (e.g. ad libitum): Tap-water, ad libitum
- Acclimation period: 7 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2°C
- Humidity (%): 40-60%
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available
IN-LIFE DATES: From: To: No data available
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The dosing solutions were prepared at concentrations 0, 250, 500 and 1000 mg/kg such that a volume of 10 ml/kg was administered daily.
DIET PREPARATION
- Rate of preparation of diet (frequency): No data available
- Mixing appropriate amounts with (Type of food): No data available
- Storage temperature of food: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water): Water
- Concentration in vehicle: 0, 250, 500 and 1000 mg/kg/day
- Amount of vehicle (if gavage): 10 ml/kg
- Lot/batch no. (if required): No data available
- Purity: No data available - Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - M/F ratio per cage: 1 : 1 ratio
- Length of cohabitation: Overnight
- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancy Sperm in vaginal smear referred to as day 0 of pregnancy
- After successful mating each pregnant female was caged (how): Individually
- Any other deviations from standard protocol: This procedure was repeated over several consecutive days until at least 30 females had been allocated to each treatment group. - Duration of treatment / exposure:
- 19 days
- Frequency of treatment:
- Daily
- Duration of test:
- 19 days
Doses / concentrations
- Remarks:
- 0, 250, 500 and 1000 mg/kg bw/day
- No. of animals per sex per dose:
- Total: 120
0 mg/kg/day: 30 female
250 mg/kg/day: 30 female
500 mg/kg/day: 30 female
1000 mg/kg/day: 30 female - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data available
Examinations
- Maternal examinations:
- Body weigth and gross appearances were observed
- Ovaries and uterine content:
- Presence of cornified and epithelial cells of Estrous cyclicity, number of corpora lutea, implantation sites, Pre-implantation losses, Early resorptions, Late resorptions and Post-implantation losses was recorded.
- Fetal examinations:
- Weight of fetuses, Sex, Gross skeletal and soft-part abnormalities were observed.
- Statistics:
- No data available
- Indices:
- Viability of fetuses were observed.
- Historical control data:
- No data available
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- effects observed, non-treatment-related
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- 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:
- not specified
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): not specified - Changes in number of pregnant:
- not specified
- Details on maternal toxic effects:
- Body weight:
No statistically significant differences were observed in treated female rats as compared to control.
Reproductive performance:
No effect were observed on number of corpora lutea, implantation sites, Pre-implantation losses, early resorptions, late resorptions and post-implantation losses of treated female rats as compared to control.
Gross pathology:
Slightly green colouring in the gastro-intestinal tract and the placental tissue were observed in treated female rats.
No other abnormalities were found in the tissues of treated female rats.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- dead fetuses
- early or late resorptions
- gross pathology
- maternal abnormalities
- necropsy findings
- number of abortions
- pre and post implantation loss
- total litter losses by resorption
- other: No effect
Maternal abnormalities
- Abnormalities:
- not specified
- Localisation:
- not specified
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): no effects observed - Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- not specified
- Changes in litter size and weights:
- not specified
- Changes in postnatal survival:
- not specified
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- not specified
- Other effects:
- not specified
- Details on embryotoxic / teratogenic effects:
- Mortality:
No effect were observed on Live foetuses f trated female rats as compared to contorl.
Body weight:
No significant effect was observed on fetuses of treated female rats as compared to control.
Gross pathology:
Statistically significant increase in fetuses with mucus in tracea were observed in 250, 500 and 1000 mg/kg/day treated female rats as compared to control.
This findings were observed at all dose levels and the incidence was not dose related.
Histopathology: Ossification of proximal phalanges and fourth metacarpals of Skeletal tissue were observed in 500 and 1000 mg/kg/day treated fetoses as compared to contorl.
Despite this association with treatment, the nature of the finding does not indicate an adverse effect.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reduction in number of live offspring
- fetal/pup body weight changes
- external malformations
- skeletal malformations
- other: No effect
Fetal abnormalities
- Abnormalities:
- not specified
- Localisation:
- other: not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
- Treatment related:
- not specified
- Relation to maternal toxicity:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Any other information on results incl. tables
Table 1.Results of the examination of the reproductive system and foetuses of female rats given 0-1000mg Green S/kg/day in aqueous solution, by oral intubation, throughout pregnancy
|
Mean no. (value)/pregnant female given doses (mg/kg/day) of: |
|||
Observation |
0 |
250 |
500 |
1000 |
Corpora lutea |
12.13 |
11.57 |
11.67 |
12.03 |
Implantations |
10.60 |
10.93 |
10.13 |
10.83 |
Pre-implantation losses |
1.57 |
0.64 |
1.54 |
1.20 |
Early resorptions |
0.50 |
0.60 |
0.40 |
0.57 |
Late resorptions |
0.03 |
0.13 |
0.17 |
0.13 |
Post-implantation losses |
0.53 |
0.73 |
0.57 |
0.70 |
Live foetuses |
10.07 |
10.20 |
9.53 |
10.13 |
Litter weight (g) |
34.2 |
34.7 |
33.6 |
35.9 |
Mean foetal weight (g) |
3.40 |
3.42 |
3.49 |
3.53 |
The results are means for groups of 30 females. There were no significant differences between the control and test groups (the exact test of Fisher, 1934): P > 0.05.
Table 2. Incidence of statistically significant findings in rat pups from females given 0-1000mg Green S/kg/day in aqueous solution, by oral intubation, throughoutpregnancy
Finding |
Dose level (mg/kg/day)... |
No. of pups affected |
|||
|
|
0 |
250 |
500 |
1000 |
Visceral findings
|
|
|
|
|
|
No. of pups examined... |
|
138 |
137 |
133 |
136 |
Mucus in tracea |
|
3 |
11* |
13** |
13** |
Skeletal findings |
|
|
|
|
|
No. of pups examined... |
|
131 |
134 |
129 |
135 |
Proximal phalanges ossified |
|
23 |
19 |
35 |
38* |
Metacarpals ossified |
|
53 |
56 |
71* |
82*** |
Values marked with asterisks differ significantly (chi-square test) from those of the control: *P <0.05; **P < 0.01; ***P < 0.001.
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 1000 mg/kg/day for P and F1 generation when Water female rats treated with Green S.
- Executive summary:
In a Combined repeated dose repro-devp. Screen, Wistar male and female rats treated with Green S in the concentration of 0, 50, 500 and 1000 mg/kg body weight/day orally in diet. In Parental generation, No effect were observed on survival, body weight, Food consumption, compound intake and water consumption of treated male and female rats as compared to control. Signs of respiratory distress, faeces, fur and extremities of all treated animals became impregnated or coated with the colouring were observed in treated and control. In addition, Significant decrease were observed in absolute stomach and empty caecum weight and increased in relative kidney weight in male and increased in absolute and relative empty and full caecum, spleen, and gonads weight in female and full caecum weight in male were observed at 1000 mg/kg body weight/day treated rats. Occasional focal inflammatory lesions were observed in the liver, heart, kidney and stomach in 1000 mg/kg bw/day and presence of colouring in wall of the uterus as a distinct ring around the placenta, and appeared to be confined to the amniotic membrane were observed in 500 and 1000 mg/kg bw/day treated female rats as compared to control. Significant increased in isolated foci or as a more widespread multifocal lesion associated with slight parenchymal necrosis and a portal inflammatory infiltrate of liver in female rats and statistically significantly increase in number of submucosal granulocytes and a slight vacuolation of overlying epithelium of stomach in male rats were observed at 1000 mg/kg bw/day as compared to control. In F1, F2 and F3 generation, Significantly decrease in number of live foetuses were observed in P generation and Slightly earlier incisors were observed in F1, F2 and F3 generation at 500 and 1000 mg/kg bw/day and in F2 and F3 generation at 50 mg/kg bw/day. This was associated with a large number of late resorptions in four animals. Significantly increased pups weight was observed in P and F1 generation at 50 mg/kg bw/day as compared to control. Both changes in P and F1 stages were associated with slightly smaller litters. Similarly, Minor variations in the degree of skeletal ossification were observed in alizarin-stained preparations, there were no differences that could be associated with treatment. Therefore, NOAEL was considered to be 500 mg/kg body weight/day for P, F1, F2 and F3 generation when Wistar male and female rats were treated with Green S orally in diet for 229 days.
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