Registration Dossier
Registration Dossier
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EC number: 240-299-7 | CAS number: 16143-80-9
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from HPVIS
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Reproductive Toxicity study of Barium lithol red in rats
- Author:
- HPVIS
- Year:
- 2 017
- Bibliographic source:
- High Production Volume Information System (HPVIS), OPPT, US EPA (Uniteted State environment protction agency), 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as below
- Principles of method if other than guideline:
- Chronic Toxicity and Potential Carcinogenicity
Study of Barium lithol red in rats - GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Barium bis[2-[(2-hydroxynaphthyl)azo]naphthalenesulphonate]
- EC Number:
- 214-160-6
- EC Name:
- Barium bis[2-[(2-hydroxynaphthyl)azo]naphthalenesulphonate]
- Cas Number:
- 1103-38-4
- Molecular formula:
- C20H14N2O4S.1/2Ba
- IUPAC Name:
- barium bis{2-[(2-hydroxy-1-naphthyl) diazenyl]naphthalene-1-sulfonate}
- Details on test material:
- - IUPAC Name: barium bis{2-[(2-hydroxy-1-naphthyl) diazenyl]naphthalene-1-sulfonate}
- Common Name: Barium lithol red
- Smiles: c12c(c(\N=N\c3c4c(ccc3O)cccc4)ccc1 cccc2) S(=O)(=O)[O-].c12c(c(\N=N\c3c4c (ccc3O)cccc4) ccc1cccc2)S(=O)(=O)[O-].[Ba+2]
- InChI: 1S/2C20H14N2O4S.Ba/c2*23-18-12-10-13-5-1-3-7-15(13)19(18)22-21-17-11-9-14-6-2-4-8-16(14)20(17)27(24,25)26;/h2*1-12,23H, (H,24,25,26);/q;;+2/p-2/b2*22-21+;
- Molecular formula:C40H26BaN4O8S2
- Molecular weight:892.127g/mol
- Substance type:Organic
- Physical state:Solid Red
Constituent 1
- Specific details on test material used for the study:
- - IUPAC Name: barium bis{2-[(2-hydroxy-1-naphthyl) diazenyl]naphthalene-1-sulfonate}
- Common Name: Barium lithol red
- Smiles: c12c(c(\N=N\c3c4c(ccc3O)cccc4)ccc1 cccc2) S(=O)(=O)[O-].c12c(c(\N=N\c3c4c (ccc3O)cccc4) ccc1cccc2)S(=O)(=O)[O-].[Ba+2]
- InChI: 1S/2C20H14N2O4S.Ba/c2*23-18-12-10-13-5-1-3-7-15(13)19(18)22-21-17-11-9-14-6-2-4-8-16(14)20(17)27(24,25)26;/h2*1-12,23H, (H,24,25,26);/q;;+2/p-2/b2*22-21+;
- Molecular formula:C40H26BaN4O8S2
- Molecular weight:892.127g/mol
- Substance type:Organic
- Physical state:Solid Red
Test animals
- Species:
- rat
- Strain:
- other: CD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: Charles river
- Age at study initiation: (P) x wks; (F1) x wks: 35 days
- Diet (e.g. ad libitum): Basal diets
Administration / exposure
- Route of administration:
- oral: feed
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- other: Basal diets
- Details on exposure:
- Not specified
- Details on mating procedure:
- - M/F ratio per cage: By pairing
- Length of cohabitation: Seven days. - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 30 Months
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Dose / conc.:
- 10 000 mg/kg bw/day
- No. of animals per sex per dose:
- Not specified
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Not specified
- Positive control:
- Not specified
Examinations
- Parental animals: Observations and examinations:
- Mortality, clinical observations, body weight were food consumption examined.
- Oestrous cyclicity (parental animals):
- Not specified
- Sperm parameters (parental animals):
- Not specified
- Litter observations:
- Sex ratio and pup viability data was examined.
- Postmortem examinations (parental animals):
- Gross pathology was examined.
- Postmortem examinations (offspring):
- Gross pathology was examined.
- Statistics:
- Not specified
- Reproductive indices:
- Reproductive performance was observed.
- Offspring viability indices:
- Not specified
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- 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
- 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 effect on reproductive performance was observed in treated rats as compared to control.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 10 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reproductive performance
- Remarks on result:
- other: No effect 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 specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- No effect on viability of pups were observed on day 0 and 4 as compared to control.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No effect on body weight of pups were observed on day 0 and 4 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):
- 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 external abnormality were observed in pups as compared to control.
- Histopathological findings:
- not specified
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
- Dose descriptor:
- other: not specified
- Generation:
- other: not specified
- Based on:
- not specified
- Sex:
- not specified
- Basis for effect level:
- other: not specified
- Remarks on result:
- other: not specified
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:
- NOAEL was considered to be 10,000 mg/kg bw for P and F1 generation when CD male and female rats were treated with Barium lithol red orally in diet for 30 month.
- Executive summary:
In a Chronic Toxicity and Potential Carcinogenicity Study,CD male and female rats were treated with Barium lithol redin the concentration of 0 and10,000 mg/kg bw/day orally in diet for 30 month. No mortality, Clinical signs,change in Body weight and Food consumption of treated rats were observed as compared to control. Similarly,No significant effect on reproductive performance of treated rat were observed as compared to control rats. In addition, no effect on reproductive parameters and gross pathologicalof treated rats were observed in treated rat as compared to control.No effect on viability, sex ratio and body weight of pups were observed as compared to control. No external abnormality were observed in pups as compared to control. Therefore, NOAEL was considered to be 10,000 mg/kg bw for P and F1 generation when CD male and female rats were treated with Barium lithol redorally in diet for 30 month.
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