Registration Dossier
Registration Dossier
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Reaction mass of tetrasodium [mono(4,4'-(1Z,1'Z)-(4,4'-dioxidobiphenyl-3,3'-diyl)bis(diazene-2,1-diyl)bis(5-amino-3-oxidonaphthalene-2,7-disulfonate(3-)) cuprate (4-)] and tetraammonium [mono(4,4'-(1Z,1'Z)-(4,4'-dioxidobiphenyl-3,3'-diyl)bis(diazene-2,1-diyl)bis(5-amino-3-oxidonaphthalene-2,7-disulfonate(3-)) cuprate (4-)]
EC number: 943-486-8 | CAS number: -
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Direct Blue 267
- IUPAC Name:
- Direct Blue 267
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- water
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- 7 days / week
- No. of animals per sex per dose:
- Male: 5 animals at 0 mg/kg bw/dayMale: 5 animals at 50 mg/kg bw/dayMale: 5 animals at 200 mg/kg bw/dayMale: 5 animals at 900 mg/kg bw/dayFemale: 5 animals at 0 mg/kg bw/dayFemale: 5 animals at 50 mg/kg bw/dayFemale: 5 animals at 200 mg/kg bw/dayFemale: 5 animals at 900 mg/kg bw/day
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- effects observed, treatment-related
- Details on results:
- Clinical observations: At 900 mg/kg, 1 male was found dead on day 8. 1 male was killed in extremis on day 9. No deaths occurred at 200 or 50 mg/kg.General signs of toxicity were observed in animals at 900 mg/kg. No general signs at 200 or 50 mg/kg.Bodyweight:Body weight of males only, at 900 mg/kg, were significantly lower than controls over the study period. No significant effect on body weight at 200 or 50 mg/kg.Laboratory findings:At 900 mg/kg, 1 male was found dead on day 8. 1 male was killed in extremis on day 9. No deaths occurred at 200 or 50 mg/kg.Effect on organs:No significant effect on organ weights at any dose.At 900 mg/kg, distinct treatment-related changes were observed in liver and adrenals. General findings included hepatocellular hyperplasia, more pronounced in males. In all males at this dose, a striking bileduct hyperplasia was observed. Females in this dose-group showed similar changes, but less marked. 4/5 males showed increased vacuolation in the cortical zone of the adrenals. There were no obvious treatment-related changes in animals at 200 or 50 mg/kg.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical signs
- gross pathology
- mortality
- Dose descriptor:
- NOEL
- Effect level:
- ca. 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical signs
- gross pathology
- mortality
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The substance was tested for repeated oral toxicity following EU Method B7. Under the experimental conditions the NOAEL is 200 mg/kg bw /day.
- Executive summary:
The substance was tested for repeated oral toxicity following EU Method B7. Male and female Wistar rats were gavaged at doses 0, 50, 200 and 900 mg/kg bw/day nominal concentration for 28 days, 7 days a week. Deaths occured only at the highest dose. Gross patologoy, body weight, clinical chemistry and clinical observations were performed. Under the experimental conditions the NOAEL is 200 mg/kg bw /day.
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