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EC number: 241-409-6 | CAS number: 17372-87-1
- 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
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 is from peer-reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Developmental Toxicity and Psychotoxicity Evaluation of test chemical in Rats
- Author:
- Charles V. Vorhees et.al
- Year:
- 2 018
- Bibliographic source:
- Arch Toxicol (1983)
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- The reproductive effect of test chemical was evaluated in Sprague-Dawley rats when administered orally in one-generation.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate
- EC Number:
- 240-474-8
- EC Name:
- Disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate
- Cas Number:
- 16423-68-0
- Molecular formula:
- C20H8I4O5.2Na
- IUPAC Name:
- disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Erythrosine
- Molecular formula (if other than submission substance): C20-H6-I4-Na2-O5
- Molecular weight (if other than submission substance): 879.86
- InChl Key (if other than submission substance): RAGZEDHHTPQLAI-UHFFFAOYSA-L
-Substance type- Organic
- Physical state: Solid (powder)
- Analytical purity:91%
- Impurities (identity and concentrations):9 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Laboratory Supply Co., Indianapolis, Indiana, USA
- Age at study initiation: adult rats
- Weight at study initiation: (P) Males: 200-220 g; Females: 200-220 g
- Fasting period before study: No data available
- Housing: No data available
- Use of restrainers for preventing ingestion (if dermal): Not applicable
- Diet (e.g. ad libitum): The experimental diets were freely available throughout postnatal development to the offspring of all delivering dams (up to the end of the experiments at 90-110 days of age of the offspring).
- Water (e.g. ad libitum): No data available
- Acclimation period: 5 days before assignment to treatment groups
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available
IN-LIFE DATES: From: To:No data available
Administration / exposure
- Route of administration:
- oral: feed
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- not specified
- Details on exposure:
- Details on exposure
PREPARATION OF DOSING SOLUTIONS: Test chemical mixed in powdered Purina rat chow.
VEHICLE
- Justification for use and choice of vehicle (if other than water):Purina rat chow were used.
- Concentration in vehicle: 0.0, 0.25, 0.5 and 1.0 % - Details on mating procedure:
- - M/F ratio per cage:1:1
- Length of cohabitation:14 days
- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancy:The presence of sperm in the daily vaginal lavage of the females and designated as day zero of gestation. - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- For male:fed diets containing the dye for 2 weeks
For female:The dye was fed to each treatment group for 2 weeks prior to breeding, 1-14 days during breeding then to the females during gestation and lactation. - Frequency of treatment:
- Daily
- Details on study schedule:
- On the day following birth two males and two females from each litter were designated for preweaning testing. Two additional males and two additional females per litter which were not tested
prior to weaning were designated for postweaning testing at weaning.
Usually the first 5-15 pairs of animals enrolled in the study in each group
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.0, 0.25, 0.5, or 1.0%( 250, 500 and 1000 mg/kg bw/d)
Basis:
no data
- No. of animals per sex per dose:
- Total: 196
0.0%: 19 male, 19 female
0.25%: 22 male, 22 female
0.5 %: 18 male, 18 female
1.0%: 21 male, 21 female
50 mg/kg (positive control): 18 male, 18 female - Control animals:
- yes
- Details on study design:
- No data available
- Positive control:
- For experiment 1:offspring injected daily with 50 mg/kg of hydroxyurea on postnatal days 2-10 of life as a positive control
For experiment 2: no positive control were used.
Examinations
- Parental animals: Observations and examinations:
- Parental animals observation 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:weekly except during breeding
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes ,every third day
- 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): No data
- Time schedule for examinations: No data
OTHER: No data - Oestrous cyclicity (parental animals):
- No data available
- Sperm parameters (parental animals):
- No data available
- Litter observations:
- Litters were examined and data collected on litter size, sex distribution, weight, and number of dead or malformed offspring.
The offspring were assessed on a series of tests using the Cincinnati Psychoteratogenicity Screening Test Battery, plus weight, food consumption, physical landmarks of development, and brain weight. - Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: All surviving animals [describe when, e.g. as soon as possible after the last litters in each generation were produced.]
- Maternal animals: All surviving animals [describe when, e.g. after the last litter of each generation was weaned.]
GROSS NECROPSY: yes
- Gross necropsy consisted of [external and internal examinations including the cervical, thoracic, and abdominal viscera.]
HISTOPATHOLOGY / ORGAN WEIGHTS
The tissues indicated in Table [#] were prepared for microscopic examination and weighed, respectively. - Postmortem examinations (offspring):
- Malformed offspring were observed.
- Statistics:
- Frequency data (e.g., mortality) were analyzed by Fisher's test
- Reproductive indices:
- No data available
- Offspring viability indices:
- Viability indice on day 1-90 were examined.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- There were no significant differences found among the groups in the experiment for food consumption prior to breeding or during gestation or lactation in the parental 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):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- No significant effects of any of the measures of reproductive performance were found in either experiment
Details on results (P0)
Food consumption: There were no significant differences found among the groups in the first Red-3 experiment for food consumption prior to breeding or during gestation or lactation in the parental animals.
Reproductive performance: No significant effects of any of the measures of reproductive performance were found in either experiment
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 compound related effects observed on body weight,food consumption and reproductive performance
- Remarks on result:
- other: No toxic effects were observed
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- no effects observed
- 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:
- no effects observed
- Description (incidence and severity):
- No malformations were seen upon external examination
- Histopathological findings:
- not specified
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- no effects observed
- Description (incidence and severity):
- No advers effect were observed onPsychotoxicity of treated pups as compared to control.
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 effects observed on external examination of offspring,food consumption,body weight.
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
Any other information on results incl. tables
Reproductive performance of test chemical
|
Treat- ment |
No. of pairs bred |
No. of dams producing litters (%) |
No. of small litters (<8 |
No. of litters remaining |
Mean (SE) gestation length |
Mean (SE) litter size |
M/F ratio |
Exp.1 |
R3 1.0 |
19 |
16(84.2) |
2 |
14 |
22.6(0.3) |
10.9(0.8) |
0.86 |
|
R3 0.5 |
22 |
19(86.4) |
5 |
14 |
22.5(0.2) |
10.5(0.7) |
0.96 |
|
R3 0.25 |
18 |
14(77.8) |
2 |
12 |
22.3(0.2) |
10.7(0.7) |
1.35 |
|
R3 0.0 |
21 |
18(85.7) |
0 |
18 |
22.6(0.1) |
11.7(0.5) |
0.89 |
|
R3 HU |
18 |
12(66.7) |
2 |
10 |
22.3(0.1) |
10.7(0.7) |
1.11 |
Exp.2 |
R3 1.0 |
22 |
16(72.7) |
1 |
15 |
21.9(0.1) |
11.3(0.5) |
1.04 |
|
R3 0.5 |
21 |
15(71.4) |
2 |
13 |
22.0(0.2) |
11.1(0.8) |
0.80 |
|
R3 0.25 |
21 |
19(90.5) |
2 |
17 |
22.1(0.1) |
11.2(0.5) |
1.15 |
|
R3 0.0 |
20 |
14(70.0) |
0 |
14 |
22.7(0.2) |
10.6(0.6) |
1.28 |
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 1.0 % (1000 mg/kg/day) for F0 and F1 generation when Sprague-dawley male and female rat were exposed to test chemical .
- Executive summary:
The reproductive and developmental effects of test chemical have been investigated in a 1-generation study in rats. The test chemical was administered at dietary dose levels of 0, 0.25, 0.5and 1.0 % (250, 500 and 1000 mg /kg bw/d) togroups of male and female Sprague-Dawley rats for two weeks prior to breeding, 1-14 days during breeding, then to females during gestation and lactation. The experimental diets were freely available to the offspring throughout postnatal development up to the age of 90-110 days. Body weights were measured weekly except during breeding. On the dayfollowing birth, all litters were examined and data collected on litter size, sex distribution,weight, and number of dead or malformed offspring. A variety of behavioural tests were determined in the offspring. Further, brainweights of day 90 were determined in the offspring. The experiment was replicated after2 years using the same exposure regimen.
The test chemical produced no effects on paternal or offspring weight or food consumption. No significant effects of any of the measures ofreproductive performance (proportion of females producing litters to those bred, thenumber of small litters, gestation length, litter size, sex ratio) were observed. No malformations were seen upon external examination. Preweaning offspring mortality was significantly increased at the 1.0 % and 0.5 % dose levels in the first experiment, but not inthe second. No adverse effects on offspring growth or adult regional brain weight were observed.No adverse effects were found in the present experiments on parental weight, food consumption, or reproductive performance.Therefore,NOAEL was considered to be 1.0 % (1000 mg/kg/day) for F0 and F1 generation when Sprague-dawleymale andfemale rat were exposed to test chemical .
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