Registration Dossier

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 on analogue substance

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
GLP compliance:
yes
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar

Administration / exposure

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

Results and discussion

Results of examinations

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

Effect levels

open allclose all
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.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

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.