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Diss Factsheets

Administrative data

Description of key information

No signs of systemic toxicity have been  observed in the repeated dose toxicity study.

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:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
GLP compliance:
yes
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
oral: unspecified
Vehicle:
other: 1% metthylcellulose
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
28 days plus 2 week recovery period for control (5 males/5 females) and top dose animals (5 males/5 females).
Frequency of treatment:
The test substance in a 1% metthylcellulose vehicle (1o ml) was administered daily by gavage.
Remarks:
Doses / Concentrations:
15, 150 and 1000 mg/kg bw/day
Basis:
other: nominal in test vehicle
No. of animals per sex per dose:
10 males and 10 females in the control group
5 males and 5 females at 15 /mg/kg bw/day
5 males and 5 females at 150 /mg/kg bw/day
10 males and 10 females at 1000 /mg/kg bw/day
Control animals:
yes, concurrent vehicle
Observations and examinations performed and frequency:
One female was foun dead in week one, but this was considered to be accidental.
Sacrifice and pathology:
No treatment-related changes were observed.
Other examinations:
Neutrophils were increased in top dose males. Decreases in alkaline phosphatase and AST were seen in top dose males and mid and top dose females, respectively. All values were normal after 2 weeks recovery.
Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
no effects observed
Water consumption and compound intake (if drinking water study):
no effects observed
Ophthalmological findings:
no effects observed
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
no effects observed
Behaviour (functional findings):
not examined
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
no effects observed
Dose descriptor:
NOAEL
Effect level:
> 1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No treatment-related changes were obersved.
Critical effects observed:
not specified
Conclusions:
The test substance was of low toxicity when administered daily over a 28-day period.
Executive summary:

No signs of systemic toxicity have been observed in the repeated dose toxicity study. Based on the information obtained this study, the substance does not need to be classified for repeated dose toxicity, according to the Regulation EC 1272/2008 and the Directive 67/584/EEC.

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

Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
This is the only repeated dose toxicity study available.

Justification for classification or non-classification

Based on the information obtained in a repeated dose toxicity study according to OECD guideline No. 407, the substance does not need to be classified for repeated dose toxicity, according to the Regulation EC 1272/2008 and the Directive 67/584/EEC.