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Description of key information

In a study according to EU Test Method B.7 (under GLP conditions) using rats, the registered substance PR 264 had a NOEL of 1000 mg/kg bodyweight in both sexes.

Key value for chemical safety assessment

Toxic effect type:
dose-dependent

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Reliability is assumed to be 1 as data are migrated from NONS files
Qualifier:
according to guideline
Guideline:
EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
GLP compliance:
yes
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Rat, Wistar, SPF
Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
Method of administration:
gavage
Duration of treatment / exposure:
28 days
Frequency of treatment:
Dosing regime: 7 days/week
Remarks:
Doses / Concentrations:
50, 200 and 1000 mg/kg bw/day
Basis:
actual ingested
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
Details on results:
Clinical observations:
Faeses and fur were discoloured red in all treatment groups.
Laboratory findings:
Haematological parameters of the treated animals are in the same range as control animals. Biochemistry parameters of treated animals are comparable to the control animals.
Effects in organs:
Most of the animals showed an enlargement of the caecum after 4 weeks. The control animals showed liquid caecal contents.
The gastro-intestinal tract was discoloured red in dose groups.
An increase of the realative kidney weight was observed in males in the high dose group; the absolute kidney weights were not significantly increased.
There are no differences between control- and recovery group.
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day.
Dose descriptor:
NOEL
Effect level:
200 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day.
Critical effects observed:
not specified
Conclusions:
In a study according to EU Test Method B.7 (under GLP conditions), the registered substance PR 264 had a NOAEL of 1000 mg/kg bodyweight.
Executive summary:

In a study according to EU Test Method B.7 (under GLP conditions), the registered substance PR 264 had a NOAEL of 1000 mg/kg bodyweight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 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

In a study according to EU Test Method B.7 (under GLP conditions) using rats, the registered substance PR 264 had a NOEL of 1000 mg/kg bodyweight in both sexes. The study is assumed to be reliable as it was provided by ECHA ina NONS file. It has been considered as key study.

Justification for classification or non-classification

As the registered substance PR 264 did not show any toxic effects for concentrations up to 1000 mg/kg bw in a repeated dose toxicity study, no classification is warranted.