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EC number: 227-497-9 | CAS number: 5858-81-1
- 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
NOAEL was considered to be 1000 mg/kg/day for F0 generation and F1 generation whenCharies river CD®male and female rat were exposed todisodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate orally in feed.
Link to relevant study records
- Endpoint:
- reproductive toxicity, other
- Remarks:
- Chronic toxicity and carcinogenicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from NTRL report
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: as below
- Principles of method if other than guideline:
- Chronic toxicity and carcinogenicity study of D&C Red #6 in rat
- GLP compliance:
- not specified
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report):Ldisodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate/ Lithol Rubine B - Molecular formula (if other than submission substance):C18H14N2O6S.2Na- Molecular weight (if other than submission substance):432.38 g/mole- Substance type:Organic
- Species:
- rat
- Strain:
- other: Charies river CD®
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: Charies river Breeding Laboratories. Iac. Wilningeon - Age at study initiation: (P) x wks; (F1) x wks: P: 36 days- Weight at study initiation: (P) Males: 75-155 g, Female: 75-114 g- Fasting period before study: No data available - Housing: Animals were housed individually in hanging wire mash cages. - Diet (e.g. ad libitum): Purina Laboratory diet, ad libitum. During post weaning segment Purina Laboratory diet, Rodent Laboratory Chow@#5001 and Certified Rodent Chow were used respectively. - Water (e.g. ad libitum): Tap water, ad libitum- Acclimation period: 15 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 71 °- Humidity (%): 53 %- Air changes (per hr): No data available - Photoperiod (hrs dark / hrs light): 12 hr light/12hr dark
- Route of administration:
- oral: feed
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- other: Purina Laboratory diet
- Details on mating procedure:
- - M/F ratio per cage: 1:1 ratio - Length of cohabitation:7 days - Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancySperm and /or copulatory plug observed in the following morning were considered to be 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):Individually - Any other deviations from standard protocol:No data available
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 126 week
- Frequency of treatment:
- Daily
- Details on study schedule:
- not specified
- Remarks:
- 0,0, 25, 150, or 1000 mg/kg bw/day
- No. of animals per sex per dose:
- Total : 1300F0 generation 0 mg/kg body weight/day: 60 male, 60 Female 0 mg/kg body weight/day: 60 male, 60 Female 25 mg/kg body weight/day: 60 male, 60 Female 150 mg/kg body weight/day: 60 male, 60 Female 1000 mg/kg body weight/day: 60 male, 60 Female F1 generation 0 mg/kg body weight/day: 70 male, 70 Female 0 mg/kg body weight/day: 70 male, 70 Female 25 mg/kg body weight/day: 70 male, 70 Female 150 mg/kg body weight/day: 70 male, 70 Female 1000 mg/kg body weight/day: 70 male, 70 Female
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- not specified
- Positive control:
- not specified
- Parental animals: Observations and examinations:
- Mortality , clinical sign, body weight, food and compound consumption, ophthalmoscopic examination, haematology, clinical chemistry, urinalysis, virology and microbiology were observed
- Oestrous cyclicity (parental animals):
- Any irregularities in the estrous cycle were investigated
- Sperm parameters (parental animals):
- not specified
- Litter observations:
- Live birth, sex, survival, body weigh, food and compound consumption, ophthalmoscopic examination, haematology, clinical chemistry, urinalysis, virology and microbiology were observed
- Postmortem examinations (parental animals):
- Gross abnormalities and organ weight were examined.
- Postmortem examinations (offspring):
- Gross abnormalities, organ weight and histopathology were examined.
- Statistics:
- Statistically analysis were performed by using fertility indices, gestation 4, 14 and 21 day survival indices were compared by using Chi- square test and /or Fishur’s extract probability. The mean number of liveborn pups per litter and the litter mean per weight at day 0,4,14 and 21 were compared by analysis of variance (one way classification), Barletts test for homogenicty of variances and the appropriate t-test (for equal and unequal variances).For F1 rat: all pair wise statistical comparison were two tailed with the probability level for significance at 0.01. Body weight, food consumption and absolute and relative body weight were compared by analysis of variances and appropriate t-test. Data for animals with malignant tumors, with beings and all tumors combined were analyzed separately by sex. Homogenicity was analysed by cor’s test and cehan-Breslow generalized Krunkal-Wallis test. For the histopathologically proired neoplastic lesions incidencus the two control groups were tested against each other.
- Reproductive indices:
- Fertility index, gestation index and effect on parturition and lactation were examined.
- Offspring viability indices:
- Yes, on day 0, 4 and 14
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Description (incidence):
- When treated with 150 mg/kg bw, 3 rats were died.When reated with 1000 mg/kg bw one rat died and in control 3 rats were died.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No effect on body weight of treated rat was observed as comparable to control.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No effect on food consumption of treated male and female rats was observed as comparable to control.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- no effects observed
- Description (incidence and severity):
- No change in treated male and female rats was observed as compared to control.
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- No change in treated male and female rats was observed as compared to control.
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- No effect on Clinical chemistry of treated male and female rats was observed as compared to control.
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- No effect on urinalysis of treated male and female rats was observed as compared to control.
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- An acceleration of testicular changes (degeneration of the testicular tubules) was observed in treated male rat, a common effect in ageing rats. However, at the termination of the study, the increased incidence was not of statistical significance.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- no effects observed
- Description (incidence and severity):
- Virology:No effect on virology of treated male and female rats was observed as compared to control.Microbiology:No effect on Microbiology of treated male and female rats was observed as compared to control.
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- No effect on Fertility index, gestation index and effect on parturition and lactation were observed as compared to control.
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- other: No effect observed
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- No effect on survival of F1 offspring were observed as compared to control.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- When treated with 1000 mg/kg bw, significant decrease in body weight were observed in male rat as comparable to control. When treated with 25 and 150 mg/kg bw, slightly decreased body weight was observed as comparable to control. Decrease in body weight were recovred in treated rats.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No effect on food consumption of treated male and female offspring’s was observed as comparable to control.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- no effects observed
- Description (incidence and severity):
- No change in treated male and female offsprings rats was observed as compared to control.
- 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:
- no effects observed
- Description (incidence and severity):
- No effect on organ weight of treated male and female offspring was observed as compared to control.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No gross pathological changes were observed in treated male and female offspring as compared to control.
- Histopathological findings:
- no effects observed
- Description (incidence and severity):
- An acceleration of testicular changes (degeneration of the testicular tubules) was observed in treated male rat, a common effect in ageing rats. However, at the termination of the study, the increased incidence was not of statistical significance.
- Other effects:
- not specified
- Behaviour (functional findings):
- not specified
- Developmental immunotoxicity:
- not specified
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- viability
- mortality
- body weight and weight gain
- food consumption and compound intake
- ophthalmological examination
- haematology
- clinical biochemistry
- urinalysis
- organ weights and organ / body weight ratios
- gross pathology
- neuropathology
- other: No effect observed
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
- 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
- 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:
- not specified
- Behaviour (functional findings):
- not specified
- Developmental immunotoxicity:
- not specified
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
- Relation to other toxic effects:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
- Conclusions:
- NOAEL was considered to be 1000 mg/kg/day for F0 generation and F1 geneartion when Charies river CD®male and female rat were exposed to disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate orally in feed.
- Executive summary:
In achronic toxicity and carcinogenicitystudy,Charies river CD®male and femalerat were exposedtodisodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate in the concentration 0, 0, 25, 150 and 1000 mg/kg/day orally in feed. In the parental generation,3 rats were died at 150 mg/kg bw, one rat died at 1000 mg/kg bw and 3 rats were died in in control. No effect onbody weight andfood consumption,ophthalmoscopic examination, haematology, clinical chemistry, urinalysis, virology and microbiologyof treated male and female rats was observed as comparable to control.Similarly, No effect on reproductive performance such asFertilityindex, gestation index and effect on parturition and lactation were observed as compared to control. No effect onorgan weight and gross pathology were observed as compared to control in P and F1 generation. In addition, anacceleration of testicular changes (degeneration of the testicular tubules) was observed in treated male rat, a common effect in ageing rats. However, at the termination of the study, the increased incidence was not of statistical significance. Therefore, NOAEL was considered to be 1000 mg/kg/day for F0 generation and F1 geneartion whenCharies river CD®male and female rat were exposed todisodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate orally in feed.
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- Dats is Klimisch 4 and from NTRL and COLIPA
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Reproductive toxicity: Oral
In different studies, disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate has been investigated for Reproductive toxicity to a greater or lesser extent. Often are the studies based on in vivo experiments and estimated data in rodents, i.e. most commonly in rats and mice for disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate along with the study available on structurally similar read across substance Carmoisine (CAS: 3567-69-9). The predicted data using the OECD QSAR toolbox has also been compared with the experimental studies.
In a experimental study given by Environmental Protection Agency, Washington, DC. Office of Toxic (National Technical Reports Library, NTRL, 1992) and Scientific Committee on Cosmetic Products (COLIPA, SCCNFP, 2004),Charies river CD®male and femalerat were exposed todisodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate in the concentration 0, 0, 25, 150 and 1000 mg/kg/day orally in feed. In the parental generation,3 rats were died at 150 mg/kg bw, one rat died at 1000 mg/kg bw and 3 rats were died in in control. No effect onbody weight andfood consumption,ophthalmoscopic examination, haematology, clinical chemistry, urinalysis, virology and microbiologyof treated male and female rats was observed as comparable to control.Similarly, No effect on reproductive performance such as Fertilityindex, gestation index and effect on parturition and lactation were observed as compared to control. No effect onorgan weight and gross pathology were observed as compared to control in P and F1 generation. In addition, anacceleration of testicular changes (degeneration of the testicular tubules) was observed in treated male rat, a common effect in ageing rats. However, at the termination of the study, the increased incidence was not of statistical significance. Therefore, NOAEL was considered to be 1000 mg/kg/day for F0 generation and F1 generation whenCharies river CD®male and female rat were exposed todisodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate orally in feed.
In another experimental study conducted by Environmental Protection Agency, Washington, DC. Office of Toxic (National Technical Reports Library, NTRL, 1992) and Scientific Committee on Cosmetic Products (COLIPA, SCCNFP, 2004),In a long term toxicity study, CD male and female mice were exposed to disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate in the concentration 0 ,0, 75, 1500 and 7500 mg/kg bw/day orally in feed. Slight compound related increase in mortality was observed in male mice during last 6 months of study at 7500 mg/kg bw. Hair and exposed sikn area appered red, a reddish brown ventral abdomen and/or anogenital region was observed readdish brown in colour at 1500 and 7500 mg/kg bw and anogenital region was observed orang in coloure at 75 mg/kg bw. No effect on body weight and food consumption of treated mice was observed as comparable to control. Similarly, No effect on reproductive organ weight and gross pathology of treated male and female mice was observed as compared to control. Revealed degenerative kidney changes were observed in 7500 mg/kg bw treated male mice. Therefore, NOAEL was considered to be 1500 mg/kg/day for male and 7500 mg/kg bw when CD male and female rat were exposed to disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate orally in feed.
Thus, based on the above studies on disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate, it can be concluded that NOAEL value is1000 mg/kg/day. Thus, comparing this value with the criteria of CLP regulation, disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate can be Not classified for reproductive toxicity.
Effects on developmental toxicity
Description of key information
NOAEL was considered to be 1000 mg/kg/day for F0 generation and F1 generation whenCharies river CD®male and female rat were exposed todisodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate orally in feed.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from NTRL report
- Qualifier:
- according to guideline
- Guideline:
- other: as below
- Principles of method if other than guideline:
- Chronic toxicity and carcinogenicity study of D&C Red #6 in rat
- GLP compliance:
- not specified
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report):Ldisodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate/ Lithol Rubine B - Molecular formula (if other than submission substance):C18H14N2O6S.2Na- Molecular weight (if other than submission substance):432.38 g/mole- Substance type:Organic
- Species:
- rat
- Strain:
- other: Charies river CD®
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Charies river Breeding Laboratories. Iac. Wilningeon - Age at study initiation: (P) x wks; (F1) x wks: P: 36 days- Weight at study initiation: (P) Males: 75-155 g, Female: 75-114 g- Fasting period before study: No data available - Housing: Animals were housed individually in hanging wire mash cages. - Diet (e.g. ad libitum): Purina Laboratory diet, ad libitum. During post weaning segment Purina Laboratory diet, Rodent Laboratory Chow@#5001 and Certified Rodent Chow were used respectively. - Water (e.g. ad libitum): Tap water, ad libitum- Acclimation period: 15 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 71 °- Humidity (%): 53 %- Air changes (per hr): No data available - Photoperiod (hrs dark / hrs light): 12 hr light/12hr dark
- Route of administration:
- oral: feed
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- other: Purina Laboratory diet
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - M/F ratio per cage: 1:1 ratio - Length of cohabitation:7 days - Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancySperm and /or copulatory plug observed in the following morning were considered to be 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):Individually - Any other deviations from standard protocol:No data available
- Duration of treatment / exposure:
- 126 week
- Frequency of treatment:
- Daily
- Duration of test:
- 126 week
- Remarks:
- 0,0, 25, 150, or 1000 mg/kg bw/day
- No. of animals per sex per dose:
- Total : 1300F0 generation 0 mg/kg body weight/day: 60 male, 60 Female 0 mg/kg body weight/day: 60 male, 60 Female 25 mg/kg body weight/day: 60 male, 60 Female 150 mg/kg body weight/day: 60 male, 60 Female 1000 mg/kg body weight/day: 60 male, 60 Female F1 generation 0 mg/kg body weight/day: 70 male, 70 Female 0 mg/kg body weight/day: 70 male, 70 Female 25 mg/kg body weight/day: 70 male, 70 Female 150 mg/kg body weight/day: 70 male, 70 Female 1000 mg/kg body weight/day: 70 male, 70 Female
- Control animals:
- yes, concurrent vehicle
- Maternal examinations:
- Mortality, clinical sign, body weight, food and compound consumption, ophthalmoscopic examination, haematology, clinical chemistry, urinalysis, virology, microbiology, Gross abnormalities and organ weight were examined.
- Ovaries and uterine content:
- not specified
- Fetal examinations:
- Live birth, sex, survival, body weigh, food and compound consumption, ophthalmoscopic examination, haematology, clinical chemistry, urinalysis, virology, microbiology, Gross abnormalities, organ weight and
- Statistics:
- Statistically analysis were performed by using fertility indices, gestation 4, 14 and 21 day survival indices were compared by using Chi- square test and /or Fishur’s extract probability. The mean number of liveborn pups per litter and the litter mean per weight at day 0,4,14 and 21 were compared by analysis of variance (one way classification), Barletts test for homogenicty of variances and the appropriate t-test (for equal and unequal variances).For F1 rat: all pair wise statistical comparison were two tailed with the probability level for significance at 0.01. Body weight, food consumption and absolute and relative body weight were compared by analysis of variances and appropriate t-test. Data for animals with malignant tumors, with beings and all tumors combined were analyzed separately by sex. Homogenicity was analysed by cor’s test and cehan-Breslow generalized Krunkal-Wallis test. For the histopathologically proired neoplastic lesions incidencus the two control groups were tested against each other.
- Indices:
- Fertility index, gestation index and effect on parturition and lactation were examined.
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Description (incidence):
- When treated with 150 mg/kg bw, 3 rats were died.When reated with 1000 mg/kg bw one rat died and in control 3 rats were died.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No effect on body weight of treated rat was observed as comparable to control.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No effect on food consumption of treated male and female rats was observed as comparable to control.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- no effects observed
- Description (incidence and severity):
- No change in treated male and female rats was observed as compared to control.
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- No change in treated male and female rats was observed as compared to control.
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- No effect on Clinical chemistry of treated male and female rats was observed as compared to control.
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- No effect on urinalysis of treated male and female rats was observed as compared to control.
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- No effect on organ weight of treated male and female rats was observed as compared to control.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No gross pathological changes were observed in treated male and female rats as compared to control.
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Description (incidence and severity):
- An acceleration of testicular changes (degeneration of the testicular tubules) was observed in treated male rat, a common effect in ageing rats. However, at the termination of the study, the increased incidence was not of statistical significance.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- no effects observed
- Description (incidence and severity):
- Virology:No effect on virology of treated male and female rats was observed as compared to control.Microbiology:No effect on Microbiology of treated male and female rats was observed as compared to control.
- Number of abortions:
- not specified
- Pre- and post-implantation loss:
- not specified
- Total litter losses by resorption:
- not specified
- Early or late resorptions:
- not specified
- Dead fetuses:
- not specified
- 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
- Other effects:
- not specified
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- clinical biochemistry
- food consumption and compound intake
- gross pathology
- haematology
- histopathology: non-neoplastic
- mortality
- ophthalmological examination
- organ weights and organ / body weight ratios
- urinalysis
- other: No effect observed
- Abnormalities:
- not specified
- Localisation:
- not specified
- Description (incidence and severity):
- not specified
- Fetal body weight changes:
- not specified
- 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
Field "Description (incidence and severity)" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.DescriptionIncidenceAndSeverityFetalPupBodyWeightChanges): When treated with 1000 mg/kg bw, significant decrease in body weight were observed in male rat as comparable to control. When treated with 25 and 150 mg/kg bw, slightly decreased body weight was observed as - 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:
- no effects observed
- Description (incidence and severity):
- No effect on survival of F1 offspring were observed as compared to control.
- Skeletal malformations:
- not specified
- Visceral malformations:
- not specified
- Other effects:
- no effects observed
- Description (incidence and severity):
- Food consumption: No effect on food consumption of treated male and female offspring’s was observed as comparable to control.Opthalmology:No change in treated male and female offsprings rats was observed as compared to control.Organ weights:No effect on organ weight of treated male and female offspring was observed as compared to control. Gross pathology:No gross pathological changes were observed in treated male and female offspring as compared to controlHistopathology:An acceleration of testicular changes (degeneration of the testicular tubules) was observed in treated male rat, a common effect in ageing rats. However, at the termination of the study, the increased incidence was not of statistical significance'
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- fetal/pup body weight changes
- changes in postnatal survival
- external malformations
- other: No effect observed
- Abnormalities:
- not specified
- Localisation:
- other:
- Description (incidence and severity):
- not specified
- 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
- Conclusions:
- NOAEL was considered to be 1000 mg/kg/day for F0 generation and F1 geneartion when Charies river CD®male and female rat were exposed to disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate orally in feed.
- Executive summary:
In achronic toxicity and carcinogenicitystudy,Charies river CD®male and femalerat were exposedtodisodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate in the concentration 0, 0, 25, 150 and 1000 mg/kg/day orally in feed. In the parental generation,3 rats were died at 150 mg/kg bw, one rat died at 1000 mg/kg bw and 3 rats were died in in control. No effect onbody weight andfood consumption,ophthalmoscopic examination, haematology, clinical chemistry, urinalysis, virology and microbiologyof treated male and female rats was observed as comparable to control.Similarly, No effect onFertilityindex, gestation index and effect on parturition and lactation were observed as compared to control. No effect onorgan weight and gross pathology were observed as compared to control in P and F1 generation. In addition, anacceleration of testicular changes (degeneration of the testicular tubules) was observed in treated male rat, a common effect in ageing rats. However, at the termination of the study, the increased incidence was not of statistical significance. Therefore, NOAEL was considered to be 1000 mg/kg/day for F0 generation and F1 generation when Charies river CD®male and female rat were exposed todisodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate orally in feed.
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:
- chronic
- Species:
- rat
- Quality of whole database:
- Dats is Klimisch 4 and from NTRL and COLIPA
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
Developmental toxicity:
In different studies, disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate has been investigated for developmental toxicity to a greater or lesser extent. Often are the studies based on in vivo experiments and estimated data in rodents, i.e. most commonly in rats and mice for disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate along with the study available on structurally similar read across substance Carmoisine (CAS: 3567-69-9). The predicted data using the OECD QSAR toolbox has also been compared with the experimental studies.
In a experimental study given by Environmental Protection Agency, Washington, DC. Office of Toxic (National Technical Reports Library, NTRL, 1992) and Scientific Committee on Cosmetic Products (COLIPA, SCCNFP, 2004),Charies river CD®male and femalerat were exposed todisodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate in the concentration 0, 0, 25, 150 and 1000 mg/kg/day orally in feed. In the parental generation,3 rats were died at 150 mg/kg bw, one rat died at 1000 mg/kg bw and 3 rats were died in in control. No effect onbody weight andfood consumption,ophthalmoscopic examination, haematology, clinical chemistry, urinalysis, virology and microbiologyof treated male and female rats was observed as comparable to control.Similarly, No effect on Fertilityindex, gestation index and effect on parturition and lactation were observed as compared to control. No effect onorgan weight and gross pathology were observed as compared to control in P and F1 generation. In addition, anacceleration of testicular changes (degeneration of the testicular tubules) was observed in treated male rat, a common effect in ageing rats. However, at the termination of the study, the increased incidence was not of statistical significance. Therefore, NOAEL was considered to be 1000 mg/kg/day for F0 generation and F1 generation whenCharies river CD®male and female rat were exposed todisodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate orally in feed.
Thus, based on the above study on disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate, it can be concluded that NOAEL value is1000 mg/kg/day. Thus, comparing this value with the criteria of CLP regulation, disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate can be Not classified for developmental toxicity.
Justification for classification or non-classification
Based on the above study on disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate, it can be concluded that NOAEL value is1000 mg/kg/day. Thus, comparing this value with the criteria of CLP regulation, disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate can be Not classified for reproduction and developmental toxicity.
Additional information
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