Registration Dossier
Registration Dossier
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EC number: 224-618-7 | CAS number: 4430-18-6
Toxicity to reproduction
Administrative data
- Endpoint:
- one-generation reproductive toxicity
- Remarks:
- based on generations indicated in Effect levels (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Data is from authorative study report
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Teratogenicity study for Acid Violet 43
- Author:
- Scientific Committee on Consumer Safety SCCS
- Year:
- 2 013
- Bibliographic source:
- Scientific Committee on Consumer Safety SCCS, OPINION ON Acid Violet 43 COLIPA n° C63, 2013
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD 414
- Principles of method if other than guideline:
- To evalute the teratogenic effect of Acid Violet 43 in female Sprague Dawley rats when they were exposed through 6-15 of gestation day by oral gavage.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Sodium 4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]toluene-3-sulphonate
- EC Number:
- 224-618-7
- EC Name:
- Sodium 4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]toluene-3-sulphonate
- Cas Number:
- 4430-18-6
- Molecular formula:
- C21H15NO6S.Na
- IUPAC Name:
- sodium 2-[(4-hydroxy-9,10-dioxo-9,10-dihydroanthracen-1-yl)amino]-5-methylbenzenesulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Name of test material (as cited in study report):Jarocol Violet 43Molecular formula (if other than submission substance): C21H14NO6S, NaMolecular weight (if other than submission substance): 431.4 g / molSmiles notation (if other than submission substance): c12c(C(c3ccccc3C2=O)=O)c(ccc1Nc1c(cc(C)cc1)S(=O)(=O)[O])O.[Na+]InChl (if other than submission substance): 1S/C21H15NO6S.Na/c11-1-6-7-14(17(10-11)29(26,27)28)22-15-89-16 (23)19-18(15)20(24)12-4-23-5-13(12)21(19)25;/h2-10,22-23H,1H3,(H,26,27,28);/q;+1/p1Substance type: OrganicPhysical state: Solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- No data available
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- water
- Details on exposure:
- - Concentration in vehicle: 0, 50, 200 or 800 mg/kg bw/day (0, 27, 109 or 435 mg active dye/kg bw/day)- Amount of vehicle (if gavage): 5 ml/kg
- Details on mating procedure:
- No data available
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 10 days (6-15 of gestattion period)
- Frequency of treatment:
- Daily
- Details on study schedule:
- The teratogenic effect of Acid Violet 43 in female Sprague Dawley rats were observed when they were exposed through 6-15 of gestation day by oral gavageat concentration of 0, 27, 109 or 435 mg active dye/kg bw/day
Doses / concentrations
- Remarks:
- Doses / Concentrations:0, 50, 200 or 800 mg/kg bw/day (0, 27, 109 or 435 mg active dye/kg bw/day)Basis:no data
- No. of animals per sex per dose:
- Total no of animals-830 mg/kg bw/day-18 female rats 27 mg/kg bw/day-23 female rats109 mg/kg bw/day-21 female rats435 mg/kg bw/day-21 female rats
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data
- Positive control:
- No data
Examinations
- Parental animals: Observations and examinations:
- •Parental animal: observation and examination: Clinical sign, body weight and food intake was observed. Placenta was also observed.
- Oestrous cyclicity (parental animals):
- No data available.
- Sperm parameters (parental animals):
- No data
- Litter observations:
- Foetuses were sexed and weighed.
- Postmortem examinations (parental animals):
- Macroscopic examination was performed.
- Postmortem examinations (offspring):
- Gross pathology-Foetuses wereobserved externely.Histopathology- About one half of the foetuses were examined for soft tissue anomalies whereas remaining foetuses were examined for skeletal anomalies following alizarin red staining.
- Statistics:
- No data
- 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
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-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:
- not specified
Details on results (P0)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 435 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Maternal toxicity was not observed at all dose level
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- not specified
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- no effects observed
Details on results (F1)
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 435 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No significant change were observed on litter parameters and foetal weight. No significant change were observed on external soft tissue and skeletal anomalies based on chemical substance treatment .
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was found to be 435 mg /kg bw/day for Acid Violet 43 in P0 female Sprague Dawley rats , when they were exposed at the concentration of 0 , 27, 109 or 435 mg /kg bw/day through 6-15 of gestation period by oral (gavage).
- Executive summary:
Combined repeated dose repro-devp. Screenwas observed for Acid Violet 43 in P0 female Sprague Dawley rats, when they were exposed at the concentration of 0 , 27, 109 or 435 mg /kg bw/day through 6-15 of gestation period by oral (gavage).
The test substance was given in water daily at dose volumes of 5 ml/kg bw by oral gavage.Dams were observed daily for clinical signs ,body weight and food intake recorded at designated intervals. The females were killed on gestation day 20, subjected to macroscopic examination, and foetuses were removed by Caesarean section. Common litter parameters were recorded and foetuses were sexed, weighed and submitted to externalexamination. About one half of the foetuses were examined for soft tissue anomalieswhereas remaining foetuses were examined for skeletal anomalies following alizarin redstaining.No mortality was observed in treated group compare to control group. Increased salivation was observed at435 mg /kg bw/day.Discolored feces at 109 and435 mg /kg bw/daywere observed. Discoloration of placenta was also observed at435 mg /kg bw/day.
No significant changes wereobserved on litter parameters and foetal weight.No significant changewere observed on external soft tissue and skeletal anomalies based on chemical substance treatment.
Therefore NOAEL was found to be435 mg /kg bw/day for Acid Violet 43 in P0 female Sprague Dawley rats.
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