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Administrative data

Description of key information

subacute 28 days, rats, o/50/200/1000 mg(kg bw/day: NOAEL ca. 50 mg/kg  bw/day

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
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 on analogue substance
Qualifier:
according to
Guideline:
EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
GLP compliance:
yes
Limit test:
yes
Species:
rat
Strain:
Wistar
Route of administration:
oral: gavage
Vehicle:
other: 4% CMC in 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/day
Male: 5 animals at 50 mg/kg bw/day
Male: 5 animals at 200 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 50 mg/kg bw/day
Female: 5 animals at 200 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day
Control animals:
yes
Clinical signs:
no effects observed
Mortality:
no mortality observed
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:
effects observed, treatment-related
Description (incidence and severity):
only at the highest dose
Behaviour (functional findings):
not specified
Gross pathological findings:
effects observed, treatment-related
Description (incidence and severity):
slight increase in the relative kidney weight on female of low and mediumdose
Details on results:
Clinical observations: No premature deaths occured. As from 14th day of treatment the animals from the medium and high dose groups exhinited black discoloration of faeces.

Gross pathology: with regard to organ weights, a clear increase in absolute kideny weights was found anmong the males from the high dose group and among female animals from the medium dose group . The relative kidney weights were slightly increased among the females from the low and medium groups

Microscopically, it was not possible to establish any substance related changes

Laboratory findings: Apart from a slight reduction in the erythrocyte count and in the haemoglobin aand haematocrit counts among the females and a sligh increase in the phosphorous and potassium values among the males from the high dose group, laboratory diagnosis did not reveal any differences from the controls
Dose descriptor:
NOAEL
Effect level:
ca. 50 mg/kg bw/day (nominal)
Based on:
test mat.
Dose descriptor:
NOEL
Effect level:
ca. 50 mg/kg bw/day (nominal)
Based on:
test mat.
Critical effects observed:
not specified
Conclusions:
The substance was tested for repeated dose toxicity (28days) following EU Method B7 and the NOAEL resulted equal to 5 mg/kb bw/day.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
50 mg/kg bw/day
Study duration:
subacute
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The analogue substance was tested for repeated dose tocivity in a subacute test ( 28 days) following EU Method B7 a the doses of 0, 50, 200 and 1000 mg/kg bw /day.

No premature death was observed and following gross pathology, sligh increase of the relative weight of kidney for female was observed at the medium dose. Dark faeces were observed for the medium and high dose level after the 14 days of administration.

Based on the read across considerations the same NOAEL value applies to Acid Black 233:1.


Repeated dose toxicity: via oral route - systemic effects (target organ) urogenital: kidneys

Justification for classification or non-classification