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EC number: 291-454-0 | CAS number: 90411-76-0
Toxicity to reproduction: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline stud< and GLP
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD TG 407
- GLP compliance:
- yes
- Type of method:
- in vivo
Test material
- Reference substance name:
- Hydrochloric acid, reaction products with aniline and nitrobenzene, sulfonated, sodium salts
- EC Number:
- 291-454-0
- EC Name:
- Hydrochloric acid, reaction products with aniline and nitrobenzene, sulfonated, sodium salts
- Cas Number:
- 90411-76-0
- Molecular formula:
- Mixture of components, no definitve molecular formula existing.
- IUPAC Name:
- Complex mixture of phenazine dyes - IUPAC name not available
- Test material form:
- other: solid
- Details on test material:
- content: 80.7 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 6 weeks
- Weight at study initiation:
---males: 185g (174-193 g)
---females: 139 g (132-149g)
- Fasting period before study:
- Housing: in groups of 2-3 animals per cage
- Diet ad libitum
- Water ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 55
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light) 12/12:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- groups of male and female Wistar rats recieved daily doses of the test item by gavage
(males 30 days and females 31 days) ;the test item was dissolved in water; the administration volume was 10 ml/kg bw - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- anylysis for stability and homogenicity
- Duration of treatment / exposure:
- 4 weeks
- Frequency of treatment:
- daily
- Duration of test:
- 4 weeks
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100, 300, 1000 mg/kg bw/day
Basis:
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- groups of male and female rats received daily doses of the test item which was dissolved ibn water, Treatment time for males included 30 days and for females 31 days. Animals were observed twice daily for mortality and morbidity, once daily for cliinical signs and were weighed, food and water consumption weekly
- Statistics:
- Dunnett-test, Dunnett exact homogenous test and heterogenous after logarithmic transformation, adjusted Mann-Whitney-U-test, Bonferroni Mann-Whitney U-test
Results and discussion
Effect levels
open allclose all
- Dose descriptor:
- other: NOAEL (general toxicity)
- Effect level:
- ca. 1 000 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: the treatment related slight discolorations are due to the staining property of the test item
- Remarks on result:
- other:
- Remarks:
- Daily oral treatment of rats with Nigrosin WLF at doses of 0, 100, 300, 1000 mg/kg b.w./day b.w. for a period of 4 weeks resulted in some black or grey green discolorations of feces/some tissues (predominantly in the lymph nodes, and less frequently in the intestine and/or Peyer's patch). All discolorations were considered to be due to the staining properties of the test item, except in small intestinal villi or other lymph nodes, which were not considered to be clearly test substance-related. In view of the very limited degree of changes, and as any indication of structural change or functional impairment of the organs concerned was lacking, they were considered to be non-adverse.
- Dose descriptor:
- other: NOAEL (reproductive organs)
- Effect level:
- ca. 1 000 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects observed
Observed effects
For reproductive organs.
No adverse effects observed
Applicant's summary and conclusion
- Executive summary:
100, 300 and 1000 mg/kg bw/day Nigrosin WLF dissolved in tap water, was administered orally by gavage to 5 male and 5 female Wistar rats per dose group for a period of 4 weeks according to OECD TG 407 and GLP in which also the effects on reproductive organs are examined.. For general toxicity see ther respective section of repeated dose toxicity. With regard to the reproductive organs no adverse effects are observed . Therefore, the NOAEL (reproductive toxicity) is considered 1000 mg/kg bw/day
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