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Diss Factsheets

Administrative data

Description of key information

To evaluate the toxicity of the test substance a subacute study in rats by oral route was performed. The study was conducted in accordance with B.7 92/69/EEC of July 31, 1992. The test substance was administered orally via gavage to groups of 6 male and 6 female Crj:CD (SD) IGS rats using target doses of 0, 8, 40, 200 and 1000 mg/kg bw/d for 4 weeks. Based oh the results of the study, 1000 mg/kg bw/d was established as the no-observed-adverse-effect-level (NOAEL) and 200 mg/kg bw/d the no-observed-effect-level (NOEL) for male and female rats.

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:
repeated dose toxicity: oral, other
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
other: Japanese Guidelines on Industrial Chemicals (1986), equivalent to 92/69/EEC used.
Qualifier:
according to guideline
Guideline:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
GLP compliance:
yes
Limit test:
no
Species:
rat
Strain:
other: SD (Crj:CD)
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
other: purified water
Details on oral exposure:
The four week treatment period was followed by a 2-week recovery period (groups 1,4 and 5 only, 6 males and 5 females per group).
Duration of treatment / exposure:
28 days
Frequency of treatment:
Dosing regime: 7 days/week
Dose / conc.:
0 mg/kg bw/day (nominal)
Dose / conc.:
8 mg/kg bw/day (nominal)
Dose / conc.:
40 mg/kg bw/day (nominal)
Dose / conc.:
200 mg/kg bw/day (nominal)
Dose / conc.:
1 000 spores/kg bw/day (nominal)
No. of animals per sex per dose:
Male: 6 animals at 0 mg/kg bw/day
Male: 6 animals at 8 mg/kg bw/day
Male: 6 animals at 40 mg/kg bw/day
Male: 6 animals at 200 mg/kg bw/day
Male: 6 animals at 1000 mg/kg bw/day
Female: 6 animals at 0 mg/kg bw/day
Female: 6 animals at 8 mg/kg bw/day
Female: 6 animals at 40 mg/kg bw/day
Female: 6 animals at 200 mg/kg bw/day
Female: 6 animals at 1000 mg/kg bw/day
Details on results:
Clinical observations:
There were no deaths.
Soiled perineal region was observed in male rats treated at 1000 mg/kg/day. Four males showed soiling from 19 days after commencement of treatment until the end of the treatment period and one showed only transient soiling. No such effects were seen in any animal during the recovery period.
No clinical signs were noted in any other group.

Laboratory findings:
No treatment-related changes in urinalysis, blood chemistry or haematology parameters were found.

Effects in organs:
No treatment-related effects were observed.
Key result
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Sex:
male/female
Remarks on result:
other: original NCD unit is mg/kg/day.
Key result
Dose descriptor:
NOEL
Effect level:
200 mg/kg bw/day (nominal)
Sex:
male/female
Remarks on result:
other: original NCD unit is mg/kg/day.
Critical effects observed:
not specified
Conclusions:
No specific toxic effect was observed
Executive summary:

To evaluate the toxicity of the test substance a subacute study in rats by oral route was performed. The study was conducted in accordance with B.7 92/69/EEC of July 31, 1992. The test substance was administered orally via gavage to groups of 6 male and 6 female Crj:CD (SD) IGS rats using target doses of 0, 8, 40, 200 and 1000 mg/kg bw/d for 4 weeks. Based oh the results of the study, 1000 mg/kg bw/d was established as the no-observed-adverse-effect-level (NOAEL) and 200 mg/kg bw/d the no-observed-effect-level (NOEL) for male and female rats.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat

Additional information

Justification for classification or non-classification

The NOAEL (>1000 mg/kg bw/day) from the 28 -day repeated dose study is above the guidance value (300 mg/kg bw/day for category 2), thus the result of that study does not indicate classification for the specific target organ toxicity-repeated exposure