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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- 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:
- Effects of FD & C red no. 40 on rat intrauterine development
- Author:
- T. F. X. COLLINS and T. N. BLACK
- Year:
- 1 980
- Bibliographic source:
- Food and cosmatics toxicology, Vol. 18. pp 561 to 568, 1980
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test of FD & C RED NO. 40 in 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): FD & C RED NO. 40 (disodium salt of 6-hydroxy-5-[(2-methoxy-5-methyl-4-sulph ophenyl)azo]-2-naphthalene sulphonic acid.) - Molecular formula (if other than submission substance): C18-H16-N2-O8-S2.2Na- Molecular weight (if other than submission substance): 496.4266 g/mole - Substance type: Oragnic - Physical state: No data available - Impurities (identity and concentrations): 5.30% NaC1, 4.50% volatile matter,0.3 % Na2SO4 and 0.26% Schaeffer's salt (an intermediate).
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Osborne-Mendel
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: FDA breeding colony
- Age at study initiation: No data available
- Weight at study initiation: 124.1 to 134.8 g
- Fasting period before study: No data available
- Housing: Animals were housed in stainless-steel hanging cages.
- Diet (e.g. ad libitum): Purina Laboratory Chow (Ralston-Purina Co., Inc., St. Louis, MO), ad libitum
- Water (e.g. ad libitum): Distilled water, ad libitum
- Acclimation period: No data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): 12 hr darkness and 12 hr light.
IN-LIFE DATES: From: To: No data available
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Distilled water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: Solutions of FD & C Red No. 40 were prepared with distilled water at 7.5, 15, 30, 100 and 200 mg FD & C Red No. 40/kg body weight daily on days 0-19 of gestation.
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): distilled water
- Concentration in vehicle: 0, 7.5, 15, 30, 100 and 200 mg/kg body weight/day
- Amount of vehicle (if gavage): 1 ml/100 g body weight
- Lot/batch no. (if required): No data available
- Purity: No data available - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- stability were tested
- Duration of treatment / exposure:
- 19 days
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:0, 7.5, 15, 30, 100 and 200 mg/kg body weight /day Basis:nominal in water
- No. of animals per sex per dose:
- 25
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Doses were selected on the basis of teratology study of FD & C Red No. 2 (Collins & McLaughlin, 1972).
- Rationale for animal assignment (if not random): No data available
- Rationale for selecting satellite groups: No data available
- Post-exposure recovery period in satellite groups: No data available
- Section schedule rationale (if not random): No data available - Positive control:
- No data available
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data available
- Time schedule: No data available
- Cage side observations checked in table [No.?] were included. No data available
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Daily
BODY WEIGHT: Yes
- Time schedule for examinations: Daily
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No data available
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data available
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data available
FOOD EFFICIENCY: No data available
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data available
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: Daily
OPHTHALMOSCOPIC EXAMINATION: No data available
- Time schedule for examinations: No data available
- Dose groups that were examined: No data available
HAEMATOLOGY: No data available
- Time schedule for collection of blood: No data available
- Anaesthetic used for blood collection: No data available
- Animals fasted: No data available
- How many animals: No data available
- Parameters checked in table [No.?] were examined. No data available
CLINICAL CHEMISTRY: No data available
- Time schedule for collection of blood: No data available
- Animals fasted: No data available
- How many animals: No data available
- Parameters checked in table [No.?] were examined. No data available
URINALYSIS: No data available
- Time schedule for collection of urine: No data available
- Metabolism cages used for collection of urine: No data available
- Animals fasted: No data available
- Parameters checked in table [No.?] were examined. No data available
NEUROBEHAVIOURAL EXAMINATION: No data available
- Time schedule for examinations: No data available
- Dose groups that were examined: No data available
- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data available
OTHER: No data available - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Other examinations:
- Presence and location of resorption sites and implantation sites, Corpora lutea, Live and dead foetuses, weight and sexed of foetuses, Gross external malformationsunder magnification, and the crown-rump length and soft tissues variations of foetuses were examined.
- Statistics:
- Statistical analysis were performed by using a least significant difference (LSD) test for numbers of corpora lutea per dam, implantations per dam, numbers of viable implants per dam, foetal body weights and crown-rump lengths. Freeman-Tukey arc-sine transformation for binomial proportions (Mosteller & Youtz, 1961) followed by an analysis of variance and an LSD test used for The number of resorptions per litter and the average number of foetuses with one or more variations per litter. Preimplantation loss data were transformed using the Freeman-Tukey arc-sine transformation followed by an analysis of variance and an LSD test. The numbers of litters with one or more resorptions, one or more skeletal or soft tissue variations and specific external, soft-tissue and skeletal variations were analysed by Fisher's exact one-tail test (Siegel, 1956). An analysis of variance was used to test maternal weight gain. An Armitage lest for linearity of proportions (Armitage, 1973) was also used to detect trends. Differences in water consumption were analysed by a paired t-test.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No external signs of toxicity and animals appeared healthy and behaved normally in treated groups as compared to control.
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No effect on maternal weight gain was observed in treated groups as compared to control.
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Description (incidence and severity):
- No effect on water comsumption was observed in treated rats as compare to control.
- 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:
- no effects observed
- Description (incidence and severity):
- When treated wtih 7.5 and 15 mg/kg bw/day , slightly increase in percentage of early resorptions were observed but this response were appe ared to be the result of sporadic occurrences. When treated wtih 100 mg/kg bw/day, One litter was totally resorbed. The percentage of females with more than one and with more than two resorptions showed no dose-related correlation as comapred to control.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 200 other: mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: No effect on clinical sign, water consumption, body weight and reproductive performance was observed.
Target system / organ toxicity
- Critical effects observed:
- no
Any other information on results incl. tables
Maternal and reproductive data for rats given FD & C red no 40 during gestation
|
|
|
Autopsy finding (mean/dam) |
|
|
Females with Resorption (%) |
|||||
|
|
|
|
|
Resorption |
|
|
|
One or more |
Two or more |
|
Mode of addministration and dose level |
no. Of pregnant females examined |
mean maternal body weigh tgain (g)* |
Corpora lutea* |
implantations* |
Early |
Late |
Viable foetuses* |
Resorption (%) |
preimplantation |
|
|
Intubation (mg/kg/day) |
|
|
|
|
|
|
|
|
|
|
|
0 |
24 |
124.1 ± 4.5 |
13.0 ± 0.3 |
11.5 ± 0.5 |
1.1 |
0.04 |
10.3 ±0.5 |
10.1 |
11.2 |
66.7 |
33.3 |
7.5 |
27 |
127.2 ± 5.6 |
13.4 ± 0.4 |
12.5 ± 0.4 |
1.4 |
0 |
11.0 ±0.6 |
11.6 |
6.9 |
48.2 |
29.6 |
15 |
28 |
134.8 ± 3.9 |
13.8 ± 0.4 |
12.7 ± 0.2 |
1.6 |
0.04 |
11.1 ± 0.3 |
12.9 |
7.8 |
71.4 |
35.7 |
30 |
28 |
128.3 ± 5.1 |
13.4±0.6 |
12.1 ± 0.5 |
1.2 |
0.04 |
10.9 ±0.6 |
10.0 |
10.2 |
64.3 |
21.4 |
100 |
26 |
123.1 ±4.4 |
13.6 ± 0.5 |
11.6 ± 0.5 |
0.7 |
0 |
11.0 ± 0.6 |
5.9 |
14.6 |
34.6 |
23.1 |
200 |
25 |
123.3 ± 4.1 |
13.0 ± 0.4 |
11.6 ± 0.4 |
1.0 |
0 |
10.6 ±0.5 |
8.3 |
11.4 |
56.0 |
20. |
*Values are means ± SEM.
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 200 mg/kg body weight /day when Osborne-Mendel female rats were treated wtih FD & C RED NO. 40.
- Executive summary:
In a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening, Osborne-Mendelfemale rats were treated wtih FD & C RED NO. 40 in the concentration of 0, 7.5, 15, 30, 100 and 200 mg/kg body weight /day in distilled water by oral gavage. No external signs of toxicity and animals were appeared healthy and behaved normally in treated groups as compared to control.No effects on weight gain and water consumption were observed in treated female rats as compared to control. No significant effect on numbers of corpora lutea, implantations, early and late deaths and viable foetuses per litter or on the percentage of preimplantation loss were observed in treated group as compared to control. Slightly increas in percentage of early resorptions were observed in 7.5 and 15 mg/kg bw/day but this response were appeared to be the result of sporadic occurrences. One litter was totally resorbed at 100 mg/kg bw/day. But, he percentage of females with more than one and with more than two resorptions showed no dose-related correlation as comapred to control. In addition, no effect on live or dead foetuses and mean foetal body weight and percentage of males and females per treatment group were observed as compared to control. Increased in number of runts were observed at 7.5, 15, 100 and 200 mg/kg bw/day treated dams, No compound-related external variations were observed in litters of treated dams as compared to control. Slightly decrease in males and females Crown-rump length were observed but were not significantly significant with increasing dose level. No effect on percentage of males and females per treatment group were observed as compared to control. Therefore, NOAEL was considered to be 200 mg/kg body weight /day when Osborne-Mendel female rats were treated wtih FD & C RED NO. 40 orally by gavage for 19 days.
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