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EC number: 247-368-0 | CAS number: 25956-17-6
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- two-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data from secondary source
Data source
Reference
- Reference Type:
- other: Secondary source
- Title:
- Two generation reproductive toxicity study of test chemical
- Author:
- HPVIS
- Year:
- 2 018
- Bibliographic source:
- HPVIS,2018
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
- Principles of method if other than guideline:
- Two generation reproductive toxicity study of test chemical
- GLP compliance:
- not specified
- Limit test:
- no
- Justification for study design:
- No data available
Test material
- Reference substance name:
- Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
- EC Number:
- 247-368-0
- EC Name:
- Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
- Cas Number:
- 25956-17-6
- Molecular formula:
- C18H16N2O8S2.2Na
- IUPAC Name:
- disodium 6-hydroxy-5-[(2-methoxy-3-methyl-4-sulfonatophenyl)diazenyl]naphthalene-2-sulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material: disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate (Allura red AC)
- IUPAC name: disodium 6-hydroxy-5-[(2-methoxy-3-methyl-4-sulfonatophenyl)diazenyl]naphthalene-2-sulfonate
- Moleclar formula: C18H16N2O8S2.2Na
- Molecular formula: 496.4266 g/mol
- Smiles: c12c(cc(cc2)S(=O)(=O)[O-])ccc(c1/N=N/c1c(cc(c(c1)C)S(=O)(=O)[O-])OC)O.[Na+].[Na+]
- InChI :1S/C18H16N2O8S2.2Na/c1-10-7-14(16(28-2)9-17(10)30(25,26)27)19-20-18-13-5-4-12(29(22,23)24)8-11(13)3-6-15(18)21;;/h3-9,21H, 1-2H3,(H,22,23,24)(H,25,26,27);;/q;2*+1/p-2/b20-19+;;
- Substance type: Organic
- Physical state: Red powder
- Purity: 96.6% (pure dye content)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Charles River Ceesarean albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data available
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- not specified
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The test chemical mixed with feed
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):
- Concentration in vehicle: 3700, 13,900 and 51,900 ppm - Amount of vehicle (if gavage):
- Lot/batch no. (if required): No data available
- Purity: No data available - Details on mating procedure:
- - M/F ratio per cage: 1:2
- Length of cohabitation: 21 days
- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancy days. The first day that sperm were observed was designated as day 0 of gestation
- After ... days of unsuccessful pairing replacement of first male by another male with proven fertility. No data available
- Further matings after two unsuccessful attempts: [no / yes (explain)] No data available
- After successful mating each pregnant female was caged (how): The females were then placed in individual cages.
- Any other deviations from standard protocol: No data available - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 27 Weeks
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- 0,3700, 13,900 and 51,900 ppm (equivalent to 0, 185, 695 and 2595 mg/kg bw per day)
- No. of animals per sex per dose:
- Total: 120
0 mg/kgbw/day: 10 male and 20 female
185mg/kgbw/day: 10 male and 20 female
695mg/kgbw/day: 10 male and 20 female
2595 mg/kgbw/day: 10 male and 20 female - Control animals:
- yes, plain diet
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Parental animals: Observations and examinations:
- Clinical observations included food consumption, appearance, individual body weights and behavior and were made weekly.
- Oestrous cyclicity (parental animals):
- No data available
- Sperm parameters (parental animals):
- No data available
- Litter observations:
- individual fetal weight and length (crown to rump), and external fetal anatomical structure were observed
- Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: All surviving animals [describe when, e.g. as soon as possible after the last litters in each generation were produced.]
- Maternal animals: All surviving animals [describe when, e.g. after the last litter of each generation was weaned.]
GROSS NECROPSY
-yes , Observations included number and placement of implantation sites, resorption sites, and live and dead fetuses; individual fetal weight and length (crown to rump), and external fetal anatomical structure. Gross necropsies were performed on each female including examination of uterus and visceral structures.
HISTOPATHOLOGY / ORGAN WEIGHTS
The tissues indicated in Table [#] were prepared for microscopic examination and weighed, respectively. - Postmortem examinations (offspring):
- SACRIFICE
- Twenty-four hours following the birth of the pups the first litters (FIA) were arbitrarily reduced to 8 maximum per mother.
- These animals were subjected to postmortem examinations (macroscopic and/or microscopic examination) as follows:
GROSS NECROPSY
- Gross necropsy consisted of [external and internal examinations including the cervical, thoracic, and abdominal viscera.]
HISTOPATHOLOGY / ORGAN WEIGTHS
The tissues indicated in Table [#] were prepared for microscopic examination and weighed, respectively. - Statistics:
- No data available
- Reproductive indices:
- No data available
- Offspring viability indices:
- No data available
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- 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
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- effects observed, treatment-related
- Description (incidence and severity):
- Fertility indices for the control and test animals of both F1A and F1B were considered low.The fertility index of the 3700 ppm test group in the F2A breeding cycle as well as the 3700 and 51900 ppm test groups in the F2B breeding cycle were reported to be low in comparison to control animals and historical control data.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 695 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reproductive performance
- Remarks on result:
- other: No toxic effects were observed
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
Results: P1 (second parental generation)
General toxicity (P1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- 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:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P1)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- effects observed, treatment-related
- Description (incidence and severity):
- The fertility index of the 3700 ppm test group in the F2A breeding cycle as well as the 3700 and 51900 ppm test groups in the F2B breeding cycle were reported to be low in comparison to control animals and historical control data.
Effect levels (P1)
- Dose descriptor:
- NOAEL
- Effect level:
- 695 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reproductive performance
- Remarks on result:
- other: No toxic effects were observed
Target system / organ toxicity (P1)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- mortality observed, treatment-related
- Body weight and weight changes:
- not specified
- 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
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- no effects observed
- Description (incidence and severity):
- Growth suppression characterized as slight was also reported for the low-level F1B pups, and the high-level F1A and F1B pups and the F2A . when compared with controls. All other measured parameters were comparable to controls in each generation and among the two filial generations.
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 695 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No evidence was seen of teratogenic or embryotoxic effects were observed
- Remarks on result:
- other: No evidence was seen of teratogenic or embryotoxic effects were observed
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
Results: F2 generation
General toxicity (F2)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- not specified
- 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
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- no effects observed
- Description (incidence and severity):
- Growth suppression characterized as slight was also reported for the F2A and F2B breeding cycles when compared with controls. All other measured parameters were comparable to controls in each generation and among the two filial generations.
Developmental neurotoxicity (F2)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F2)
- Developmental immunotoxicity:
- not specified
Effect levels (F2)
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- 695 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No evidence was seen of teratogenic or embryotoxic effects were observed
- Remarks on result:
- other: No evidence was seen of teratogenic or embryotoxic effects were observed
Target system / organ toxicity (F2)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The NOAEL was considered to be 695 mg/kg bw for F0 and F1 generation , when male and female rats were treated with test chemical orally .
- Executive summary:
Two generation reproductive toxicity study of test chemical was performed on male and femaleCharles River Ceesarean albino rats . The test chemical mixed with food in dose concentration 0,3700, 13,900 and 51,900 ppm (equivalent to 0, 185, 695 and 2595 mg/kg bw per day) were administered for 27 weeks .These P1 parental generations were individually housed. Clinical observations included food consumption, appearance, individual body weights and behavior and were made weekly. The F1A weanling rats designated P2 generation were kept 4-5 to a cage according to sex and maintained on the same concentration level as their parents until reaching maturity. During the breeding phase of the P1 generation, two females and one male were placed in a breeding cage. At weekly intervals during the mating period, the males were rotated among the females in each group. Following mating, the females were placed in individual cages to produce the first (FIA) litters. Twenty-four hours following the birth of the pups the first litters (FIA) were arbitrarily reduced to 8 maximum per mother. The number of conceptions, number of litters, live births, stillbirths, size of natural and nursing litters, deaths during the period of lactation, and number of pups weaned were recorded. The body weights of each pup were recorded at 24 hours and at weaning. Gross signs of toxicity were monitored. After 21-days of nursing, random pups were sacrificed and gross necropsies performed. Twenty-four females and twelve males remaining from each test group and control group were selected at random and designated the P2 generation. Following the weaning of the F1A animals, the P1 generation was remated to produce their second litters referred to as F1B, according to the procedures described above.
The P2 generation was housed 4-5 per cage and was maintained on the same dietary levels as their parents. The procedures outlined above for the P1 generation were maintained for the P2 generation. The litters of the P2 animals were referred to as the F2A litters. Body weights of the F2A pups were monitored 24 hours following the birth and at weaning. Gross signs of toxicity were recorded. Following a 21-day nursing period, all pups were weaned and sacrificed. One week following the weaning period of the F2A litter, the P2 generation was remated to produce their second litters (F2B). Two females were placed in a cage with a male from the corresponding dose group. Males were rotated weekly, and females were examined daily for presence of spermatozoa for a maximum of 21 consecutive days. The first day that sperm were observed was designated as day 0 of gestation. The females were then placed in individual cages. Half of the females (12) were sacrificed on day 19 or 20 of gestation and Caesarean sections were performed. Observations included number and placement of implantation sites, resorption sites, and live and dead fetuses; individual fetal weight and length (crown to rump), and external fetal anatomical structure. Gross necropsies were performed on each female including examination of uterus and visceral structures. The remaining 12 females were allowed to litter normally. The fetuses of both females delivering normally and via Caesarean section were necropsied.Fertility indices for the control and test animals of both F1A and F1B were considered low. The authors attributed this to the advanced age of the animals upon mating. The fertility index of the 3700 ppm test group in the F2A breeding cycle as well as the 3700 and 51900 ppm test groups in the F2B breeding cycle were reported to be low in comparison to control animals and historical control data.
Offspring toxicity F1 and F2: Growth suppression characterized as slight was also reported for the low-level F1B pups, and the high-level F1A and F1B pups and the F2A and F2B breeding cycles when compared with controls. All other measured parameters were comparable to controls in each generation and among the two filial generations. HenceThe NOAEL was considered to be 695 mg/kg bw for F0 and F1 generation , when male and female rats were treated with test chemical orally .
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