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EC number: 262-538-4 | CAS number: 60958-41-0
- 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
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- 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:
- data from handbook or collection of data
- Justification for type of information:
- data from peer reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- STUDY OF THE TERATOGENIC POTENTIAL OF FD & C RED NO. 40 WHEN GIVEN BY GAVAGE TO RATS
- Author:
- T. F. X. COLLINS, T. N. BLACK, J. J. WELSH and L. H. BROWN
- Year:
- 1 989
- Bibliographic source:
- Fd Chem. Toxic. Vol. 27, No. 11, pp. 707-713. 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Reproductive toxicity of FD & C RED NO. 40 was assessed in Osborne-Mendel rats in 20 days study
- 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
- 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:
- - Name of test material: FD & C RED NO. 40 (ALLURA RED)
- IUPAC name: disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate
- Substance type: Organic
- Physical state: solid
Test animals
- Species:
- rat
- Strain:
- Osborne-Mendel
- Details on species / strain selection:
- No data available
- 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 pro).
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
FD & C Red No. 40, Certified Batch No. AA-4181 was dissolved in distilled water (w/v). Fresh solutions were prepared 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):
- Concentration in vehicle: 0, 30, 75, 150, 300, 600 or 1000mg/kg/day.
- Amount of vehicle (if gavage): 1ml/100g body weight
- 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: 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:
- 19 days (Gestation day 0 to day 19)
- Frequency of treatment:
- Daily
- Details on study schedule:
- No data available
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
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule:
- Cage side observations checked in table [No.?] were included.
DETAILED CLINICAL OBSERVATIONS:No data
- Time schedule:
BODY WEIGHT: Yes
- Time schedule for examinations:The rats were weighed daily
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): yes ,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:
OTHER: - Oestrous cyclicity (parental animals):
- No data
- Sperm parameters (parental animals):
- No data
- Litter observations:
- STANDARDISATION OF LITTERS:No data available
- Performed on day 4 postpartum: [yes/no]
- If yes, maximum of [...] pups/litter ([...]/sex/litter as nearly as possible); excess pups were killed and discarded.
PARAMETERS EXAMINED
The following parameters were examined in [F1 ] offspring:
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.
GROSS EXAMINATION OF DEAD PUPS:Yes
[no / yes, for external and internal abnormalities; possible cause of death was/was not determined for pups born or found dead.]
ASSESSMENT OF DEVELOPMENTAL NEUROTOXICITY: No data available
ASSESSMENT OF DEVELOPMENTAL IMMUNOTOXICITY:No data available - 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: On day 20 of gestation,
GROSS NECROPSY: yes ,the females were examined for gross abnormalities for the last time before being killed by CO, 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.
-
HISTOPATHOLOGY / ORGAN WEIGHTS: yes
The tissues indicated in Table [#] were prepared for microscopic examination and weighed, respectively. - Postmortem examinations (offspring):
- SACRIFICE: yes
- The F1 offspring not selected as parental animals and all F2 offspring were sacrificed at [#?] days of age.
- These animals were subjected to postmortem examinations (macroscopic and/or microscopic examination) as follows:
GROSS NECROPSY:yes
HISTOPATHOLOGY / ORGAN WEIGTHS
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:
- no effects observed
- Description (incidence and severity):
- No unusual behaviours were observed in the animals during the study.The external maternal findings were unremarkabke.
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- One female inthe group given 300mg/kg died at day 12 of gestation as a result of gavage difficulties unrelated to dosage
- 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 examined
- 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 examined
- Histopathological findings: non-neoplastic:
- not examined
- 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:
- no effects observed
- 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. The mean number of viable foetuses per female was similar in all groups. The number of viable male foetuses was increased over the control value in the groups given 30 and 1000mg/kg, but because of the lack of relation to dosage, these increases were considered to be random. The number of viable female foetuses was not affected in any group. 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.
Details on results (P0)
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
Initial body weight at day 0 and maternal body-weight gain during gestation were similar in all groups
REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS)
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. The mean number of viable foetuses per female was similar in all groups. The number of viable male foetuses was increased over the control value in the groups given 30 and 1000mg/kg, but because of the lack of relation to dosage, these increases were considered to be random. The number of viable female foetuses was not affected in any group. 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.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No maternal toxicity effects observed
- Remarks on result:
- other: No effects on reproductive parametes was observed
Target system / organ toxicity (P0)
- 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
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not examined
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- 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 examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- 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:
- no effects observed
- Description (incidence and severity):
- No dose-related increase in sternebral variations was seen among the foetuses with reduced ossification, bipartite, missing, malaligned or fused sternebrae,nor in the numbers of litters containing these foetuses. The incidence of specific skeletal variations was similar in all groups of foetuses, except for a significant increase in the incidence of 14th rib bud in foetuses from the 300 mg/kg group which was considered to be a random occurrence.
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Details on results (F1)
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.
GROSS PATHOLOGY
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.
OTHER FINDINGS (OFFSPRING)
No dose-related increase in sternebral variations was seen among the foetuses with reduced ossification, bipartite, missing, malaligned or fused sternebrae,
nor in the numbers of litters containing these foetuses. The incidence of specific skeletal variations was similar in all groups of foetuses, except for a significant increase in the incidence of 14th rib bud in foetuses from the 300 mg/kg group which was considered to be a random occurrence.
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- viability
- body weight and weight gain
- gross pathology
- other:
- Remarks on result:
- other: No developmental effects was obseved
Target system / organ toxicity (F1)
- 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
Overall reproductive toxicity
- 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
Applicant's summary and conclusion
- Conclusions:
- In reproductive and developmental toxicity study, The NOAEL was considered to be 1000mg/kg bw as no effects on reproductive performance and developmental of fetus was observed , when Osborne-Mendel male and female rats were treated with FD & C RED NO. 40 orally in 20 days .
- Executive summary:
The reproductive and developmental toxicity study of FD & C RED NO. 40(25956-17-6) was performed on male and female Osborne-Mendel rats. The test material was dissolved in distilled water (w/v). Fresh solutions were prepared daily. The dose concentration of 0, 30, 75, 150, 300, 600 or 1000mg/kg/day was administered by oral gavage route in volume 1ml/100g body weight .On mating days , two females were randomly mated with one male at approximately 4.30pm. The following morning, a vaginal smear was obtained from each female to determine whether copulation had taken place. Sperm positive dams were considered to be at day 0 of gestation. 42-43 female/dose groups were used. All the animals were observed for signs of toxicity. The rats were weighed daily and food consumption was measured weekly. Water intake was not measured. On day 20 of gestation, the females were examined for gross abnormalities for the last time before being killed by CO, 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. 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. 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.
No unusual behaviours were observed in the animals during the study. The external maternal findings were unremarkable. One female in the group given 300mg/kg died at day 12 of gestation as a result of gavage difficulties unrelated to dosage. Initial body weight at day 0 and maternal body-weight gain during gestation were similar in all groups. 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. 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. The mean number of viable foetuses per female was similar in all groups. The number of viable male foetuses was increased over the control value in the groups given 30 and 1000mg/kg, but because of the lack of relation to dosage, these increases were considered to be random. The number of viable female foetuses was not affected in any group. 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. 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. 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. No dose-related increase in sternebral variations was seen among the foetuses with reduced ossification, bipartite, missing, malaligned or fused sternebrae,nor in the numbers of litters containing these foetuses. The incidence of specific skeletal variations was similar in all groups of foetuses, except for a significant increase in the incidence of 14th rib bud in foetuses from the 300 mg/kg group which was considered to be a random occurrence. Hence the NOAEL was considered to be 1000mg/kg bw as no effects on reproductive performance and developmental of fetus was observed, when Osborne-Mendel male and female rats were treated with FD & C RED NO. 40 orally in 20 days.
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