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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
repeated dose toxicity: oral
Adequacy of study:
other information

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex V
GLP compliance:
yes
Limit test:
no

Test animals

Species:
other: Rat (Wistar Crl:(WI) BR)

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: 1% Aqueous carboxymethylcellulose
Details on oral exposure:
Method of administration:
Gavage
Duration of treatment / exposure:
Test duration: 28 days
Frequency of treatment:
Dosing regime: 7 days/week
No. of animals per sex per dose:
Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 15 mg/kg bw/day
Male: 5 animals at 45 mg/kg bw/day
Male: 5 animals at 150 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 15 mg/kg bw/day
Female: 5 animals at 45 mg/kg bw/day
Female: 5 animals at 150 mg/kg bw/day

Results and discussion

Results of examinations

Details on results:
Clinical observations:
Mortality

There was no treatment-related deaths during the study.


One male dosed at 150 mg/kg died during blood sampling,
however, this death was considered to be
non-treatment-related.


Clinical Signs

No clinical signs indicative of toxicity were noted among
the animals.


Slight post-dosing salivation was noted among the treated
animals in a dose-related manner. This clinical sign is
often noted in rats of this age and strain following oral
gavage and may be related to multiple intra-oesophageal
intubation and/or irritant or bad taste of the test
substance. This sign was observed immediately after dosing
only.



Functional Observations

No changes were observed in hearing ability, pupillary
reflex, static righting reflex and grip strength in the
treated animals compared with control animals. The variation
in motor activity was not treatment related.


Decreased average total high sensor readings were noted
among treated males. Since supportive clinical signs and a
dose-response relationship was absent, no toxicological
significance was attached to this finding.

Laboratory findings:
Haematology

No significant changes in haematological parameters were
noted for the treated animals.



Clinical Biochemistry

Increases in alanine aminotransferase activity and aspartate
aminotransferase activity was noted in males and females
treated at 150 mg/kg, respectively. However, it was
attributed to one single value for both cases.

Effects in organs:
Macroscopic Examination

Macroscopic observations at necropsy did not indicate any
alterations that were considered to be treatment-related.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
150 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day.
Dose descriptor:
NOEL
Effect level:
45 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Classified as: Not classified