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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental 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:
- 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:
- Test chemicalwas given in diet to Sprague-Dawley rats From parent to offspring generation to evaluate the developmental toxicity and psychotoxicity effects.
- 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 % impurities
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:Laboratory Supply Co., Indianapolis, Indiana, USA
- Age at study initiation:90-110 days of age of the offspring
- Weight at study initiation:Male (200-220 g) and female (200-220 g)
- Fasting period before study:No data available
- Housing:No data available
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period:5 days
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 % - Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - Impregnation procedure: [artificial insemination / purchased timed pregnant / cohoused]:cohoused
- If cohoused:
- M/F ratio per cage:1:1
- Length of cohabitation:Till the confirmation of breeding
- Further matings after two unsuccessful attempts: [no / yes (explain)]:No data
- Verification of same strain and source of both sexes: [yes / no (explain)]:No data
- 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.
- Any other deviations from standard protocol:No data - 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
- Duration of test:
- From parent to offspring generation
Doses / concentrations
- Remarks:
- 0.0, 0.25, 0.5, or 1.0%( 250, 500 and 1000 mg /kg bw/day )
- 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
Examinations
- Maternal examinations:
- BODY WEIGHT: Yes
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
OTHER:females for reproductive success. - Ovaries and uterine content:
- No data available
- Fetal examinations:
- Cincinnati Psychoteratogenicity Screening Test Battery, plus weight, food consumption, physical landmarks of development, and brain weight.
- Statistics:
- Analysis of variance for unequal group sizes, with split-plot designs where repeated measures were made, were performed on the majority of the data. Duncan a posteriori multiple range comparison tests for unequal group sizes (Kramer 1956) were used on those measures on which significant F-ratios occurred. Frequency data (e.g., mortality) were analyzed by Fisher's test for uncorrelated proportions (Guilford 1965). On preweaning tests, data on individual subjects were averaged for the entire litter or within sex and the litter was, therefore, the unit of analysis. On postweaning tests, only one male and one female was used from each litter on any given test,therefore, litter was again the unit of analysis, but no litter averaging was required. Because of the large number of tests done, and therefore, the number of statistical tests required, effects were only accepted as significant if the overall test (i.e., usually an F-test) occurred at a level ofp < 0.01 or beyond. Follow-up a posteriori individual group comparisons, however, were less stringent (p < 0.05) under the assumption that the F-test provided an adequate protection level when used at p < 0.01.
- Indices:
- No data available
- Historical control data:
- No data available
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- 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
- 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
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- not specified
- Early or late resorptions:
- not specified
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- no effects observed
- Changes in number of pregnant:
- no effects observed
- Other effects:
- not specified
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Remarks on result:
- other: No reproductive toxic effects were observed
Maternal abnormalities
- Abnormalities:
- not specified
- Localisation:
- not specified
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- no effects observed
- External malformations:
- no effects observed
- Skeletal malformations:
- not specified
- Visceral malformations:
- not specified
- Other effects:
- no effects observed
- Description (incidence and severity):
- No advers effect were observed onPsychotoxicity of treated pups as compared to control.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- fetal/pup body weight changes
- changes in postnatal survival
- external malformations
- Remarks on result:
- other: No developmental toxic effects were observed
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
- Treatment related:
- not specified
Any other information on results incl. tables
Offspring mortality expressed as a % of those alive at the beginning of each phase
|
Treatment |
Days of age |
No. Of liveoffspring after culling on day 1 |
||
1-21 |
22-24 |
25-90 |
|||
Experiment 1 |
R3 1.0 |
9.3a |
0.0 |
0.7 |
161 |
R3 0.5 |
10.2a |
0.0 |
1.5 |
147 |
|
R3 0.25 |
1.5 |
0.0 |
0.0 |
128 |
|
R3 0.0 |
3.2 |
0.0 |
0.8 |
412 |
|
R3 HU |
8.6a |
0.0 |
1.5 |
219 |
|
|
|
|
|
|
|
Experiment 2 |
R3 1.0 |
9.9a |
0.0 |
6.9 |
161 |
R3 0.5 |
15.9a |
0.0 |
3.4 |
157 |
|
R3 0.25 |
23.3 |
0.0 |
1.0 |
193 |
|
R3 0.0 |
22.5 |
0.0 |
0.0 |
129 |
|
aSignificantly different from the 0% dye exposure group, p < 0.01 |
Swimming development ratings (mean _+ SE)
|
Treatment |
na |
Swimming-direction day 6 |
na |
Swimming-angle day 10 |
Experiment 1 |
R3 1.0 |
14 |
1.9±0.1 |
12 |
2.4±0.2* |
R3 0.5 |
13 |
1.6±0.1 |
13 |
2.1±0.1 |
|
R3 0.25 |
12 |
1.8±0.1 |
11 |
2.4±0.3* |
|
R3 0.0 |
35 |
1.7±0.1 |
35 |
1.8±0.1 |
|
R3 HU |
19 |
1.7±0.1 |
19 |
2.1±0.2 |
|
|
|
|
|
|
|
Experiment 2 |
R3 1.0 |
14 |
2.2±0.2** |
14 |
1.9±0.1 |
R3 0.5 |
13 |
2.6±0.2 |
13 |
2.1±0.2* |
|
R3 0.25 |
14 |
2.6±0.1 |
14 |
2.3±0.2** |
|
R3 0.0 |
11 |
2.6±0.2 |
11 |
1.9±0.2 |
|
* F-test p < 0.01, individual group comparison to R3 0.0 group, p < 0.05 ** F-test p < 0.01, individual group comparison to R3 0.0 group, p < 0.01 an represents the number of litters tested, n varies slightly due to missing data points n = 35 in the R3 0.0 group because of controls from a previous similar experiment |
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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