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EC number: 281-619-5 | CAS number: 84000-63-5
- 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:
- one-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- 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-reviewed journal.
Data source
Reference
- Reference Type:
- publication
- Title:
- Reproductive toxicity of test material was assessed in Osborne-Mendel rats in 20 days study
- Author:
- COLLINS,et.al
- Year:
- 1 989
- Bibliographic source:
- Fd Chem. Toxic.
Materials and methods
- Principles of method if other than guideline:
- The present study was conducted to determine the reproductive toxicity potential of FD & C RED NO. 40 (CAS No.- 25956-17-6) when given by gavage to rats.
- GLP compliance:
- not specified
- Limit test:
- no
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
- Details on test material:
- - Name of test material (as cited in study report): disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
(ALLURA RED AC)
- Substance type: Organic
- Physical state: solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Certified Batch No. AA-4181, was obtained from Buffalo Color Corporation (Buffalo, NY, USA).
Test animals
- Species:
- rat
- Strain:
- Osborne-Mendel
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: FDA rat breeding colony
- Age at study initiation: female: 12 - 21 wk
- Weight at study initiation:female: 220 - 270 g
- Fasting period before study: no data
- Housing: Stainless-steel hanging cages.
- Use of restrainers for preventing ingestion (if dermal): no
- Diet (e.g. ad libitum): Purina Laboratory Chow ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 25 deg C
- Humidity (%): 30 - 63%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12-hr light/dark cycle (8 am - 8 pm).
IN-LIFE DATES: From: To: no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- FD & C Red No. 40, Certified Batch No. AA-4181 was dissolved in distilled water (w/v). Fresh solutions were prepared daily and administered by gavage in a volume of 1 ml/100 g body weight, at approximately the same time each day. Controls received an equivalent volume of distilled water.
- Details on mating procedure:
- - M/F ratio per cage: 1:2
- Length of cohabitation: 1 day
- Proof of pregnancy: sperm in vaginal smear was considered day 0 of gestation
- After ... days of unsuccessful pairing replacement of first male by another male with proven fertility: no data
- Further matings after two unsuccessful attempts: no data
- After successful mating each pregnant female was caged (how): no data
- Any other deviations from standard protocol: no data - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Gestation day 0 to day 19
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 30, 75, 150, 300, 600 or 1000mg/kg/day.
Basis:
nominal in water
- No. of animals per sex per dose:
- 42 - 43 female/dose group.
- Control animals:
- yes, concurrent vehicle
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: No data
- Time schedule: No data
- Cage side observations checked in table [No.?] were included. No data
DETAILED CLINICAL OBSERVATIONS: No data
- Time schedule: No data
BODY WEIGHT: Yes
- Time schedule for examinations: The rats were weighed daily.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Food consumption was measured weekly.
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Water intake was not measured.
- Time schedule for examinations: no data
- Oestrous cyclicity (parental animals):
- No data
- Sperm parameters (parental animals):
- No data
- Litter observations:
- Each live foetus was promptly weighed, sexed and examined for gross external malformations, and the crown-rump length was measured. Any foetus that weighed less than 70% of the average weight of the concurrent male or female controls was considered to be a runt.
- Postmortem examinations (parental animals):
- On day 20 of gestation, starting at 1 pm, the females were examined for gross abnormalities for the last time before being killed by CO2, asphyxiation. Caesarean sections were performed. Corpora lutea were counted. The uterus was opened and examined in situ. The uterine positions of all implantation sites were noted and their condition (early or late resorptions, living or dead foetuses) was determined.
- Postmortem examinations (offspring):
- Approximately one-half of the foetuses were fixed in alcohol, stained with Alizarin Red S and examined under a dissecting microscope for all skeletal variations. The remaining half of the foetuses were fixed in Bouin's solution, serially sectioned by razor blade and examined under a dissecting microscope for internal variations of the soft tissues.
- Statistics:
- All data analyses were performed by the Division of Mathematics at the FDA. Data on maternal initial body weights and food consumption were analysed by straight analysis of variance (ANOVA) and two-tailed t-test, and a regression analysis. The number of dams affected was analysed by a Fisher's exact test. Data on maternal weight gain were submitted to an analysis of covariance (ANOCOVA) and a two-tailed t-test. Data on the numbers of implants, corpora lutca, total viable young and viable males and females were analysed by ANOVA followed by a one-tailed t-test. Data on implantation efficiency, early deaths, late deaths and total resorptions (early and late deaths) were transformed by using the Freeman-Tukey arc-sine transformation (Freeman and Tukey, 1950) and then analysed by ANOVA and a one-tailed t-test. Data on litters having one or more or two or more resorptions were analysed by a Fisher's exact test. Similar tests were applied to the number of runts per litter. Data on foetal body weights, crown-!o-rump lengths and foetal ossified vertebrae were analysed by nested ANOVA and a one-tailed t-test. The ANOVA included a correction for unequal sample size (Sokal and Rohlf, 1981). Data on the average number of foetuses per litter with skeletal, sternebral, combined missing plus incomplete plus bipartite sternebrae or soft-tissue variations were transformed by using the Frceman-Tukey arc-sine transformation and then analysed by ANOVA and a one-tailed t-test. Litters with foetuses with at least one, at least two, etc. skeletal, sternebral, combined missing plus incomplete plus bipartite sternebrae, or soft-tissue variations, and specific variations were analysed by Fisher's exact test.
- Reproductive indices:
- No data
- Offspring viability indices:
- No data
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:
- no effects observed
- Description (incidence and severity):
- Initial body weight at day 0 and maternal body-weight gain during gestation were similar in all groups.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- Mean food consumption on days 0-7, 7-14, 14-20 and 0-20 by the treated animals was similar to that of the control animals.
- 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):
- no effects observed
- Description (incidence and severity):
- No unusual behaviours were observed in the animals during the study.
- 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 examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- effects observed, treatment-related
- Description (incidence and severity):
- The pregnancy rate ranged from 85.71 to 95.35% with no evidence of dose correlation.
The mean numbers of corpora lutea and implants per female were similar in all groups. No litters were totally resorbed.
Details on results (P0)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No dose-related maternal effects occurred when FD & C Red No. 40 was given by gavage.
Target system / organ toxicity (P0)
- Critical effects observed:
- no
Results: P1 (second parental generation)
Effect levels (P1)
- Remarks on result:
- not measured/tested
Target system / organ toxicity (P1)
- Critical effects observed:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- The mean number of viable foetuses per female was similar in all groups.
The number of early deaths per litter and the number of early plus late deaths per litter were greatest in the 600 mg/kg group, but these appeared to be random occurrences. The percentage of females with at least one resorption was similar in all groups. The percentage of females given 600mg/kg that had at least two resorptions was significantly greater than the percentage in the control females, but there was no dose related effect in the percentage of females with at least two resorptions. - Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Mean foetal weights of males and females and crown rump lengths were similar in all groups. The number of litters with runts was similar in all groups.
- 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:
- effects observed, treatment-related
- Description (incidence and severity):
- Aside from haemorrhages present in foetuses in all groups in similar numbers, there were no other external variations in any of the dosed groups. Two foetuses had multiple anomalies: one foetus from the control group had a club foot, a short tail and four digits on the hind legs, and one foetus from the 150-mg/kg group had exencephalus and hydrocephalus. Three foetuses in a single litter of a female given 75 mg/kg were oedematous.
- Histopathological findings:
- not examined
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Details on results (F1)
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No developmental toxicity was observed.
Target system / organ toxicity (F1)
- Critical effects observed:
- no
Results: F2 generation
Effect levels (F2)
- Remarks on result:
- not measured/tested
Target system / organ toxicity (F2)
- Critical effects observed:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Under the condition of this study, the no-observed-adverse-effect level (NOAEL) for maternal and developmental toxicity study was found to be 1000.0 mg/kg bw/day.
- Executive summary:
The present study was conducted to determine the reproductive toxicity potential of FD & C RED NO. 40 (CAS No.- 25956-17-6) when given by gavage to rats. Osborne-Mendel rats were intubated with FD & C Red No. 40 at dose levels of 0, 30, 75, 150, 300, 600 or 1000 mg/kg body weight/day on days 0-19 of gestat ion. No developmental toxicity was observed when the animals were killed on day 20 of gestation. No dose-related changes were seen in maternal daily obser vations, food consumption, body-weight gain or implantations, or in foetal viability, body weight, body length, sex distribution or external variations. Skeletal and soft-tissue development appeared similar in foetuses of all groups. The isolated increases that occurred in the number of male foetuses, number of females with two or more resorptions, number of litters with three or more sternebral variations and incidence of 14th rib bud are considered random occurrences and were not related to dosage. Thus, under the condition of this study, the no-observed-adverse-effect level (NOAEL)for maternal and developmental toxicity study was found to be 1000.0 mg/kg bw/day.
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