Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
Principles of method if other than guideline:
other: Acute oral toxicity study in male and female Wistar-rats
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity: 99.1%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:
- Age at study initiation: male: 6-7 weeks; female 8-9 weeks
- Weight at study initiation: male 183 g, female 162 g
- Fasting period before study: 16 h
- Housing:
- Diet ad libitum
- Water ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 55
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light):12/12

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
single oral application by gavage of test substance diluted in polyethylene glycol
Doses:
200 mg/kg bw
2000 mg/kg bw (administered only to female rats)
No. of animals per sex per dose:
200 mg/kg bw (5 male and 5 female rats)
2000 mg/kg bw (5 female rats )
Control animals:
not specified
Details on study design:
males were not fed with 2000 mg/kg bw because all females died;
observation for clinical signs and mortality for up to 14 days, body weight determination on day 1, and at the end of the observation period;
pathological-anatomical evaluation after termination of the study
Statistics:
calculation of LD50- value according to Spearman - Kärber, or if only 1 dose used. estimation of the LD50-value

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 632 mg/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
> 200 mg/kg bw
Mortality:
male : 0/5 (200 mg/kg bw)
female: 0/5 (200 mg/kg bw)
female 5/5 (2000 mg/kg bw)
Clinical signs:
200 mg/kg bw was tolerated without clincal symptoms from male amd female rats
2000 mg/kg bw: 15 min post dosing animals suffered from "spasmic-jumping behaviour" ; 20 min post application all female rats died
Body weight:
there were no effects on body weight development in males and females receiving 200 mg7kg bw
Gross pathology:
2000 mg/kg bw, female: stomach filled with yellowish liquid, reddened mucous membranes of the stomach, and the lungs
200 mg/kg bw, males and females were without gross pathological findings

Any other information on results incl. tables

Sex   Dose (mg/kg bw)  No. of animals (mortalities/animals used)  Timepint of death  Mortality (%)
 male   200  0/5  -  0
 female   200  0/5  -  0
 female  2000  5/5  20 minutes  100

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The approximately LD50 value for female rats was 632 mg/kg bw and the LD50 value for male rats was >200 mg/kg bw (Bayer AG.1995)
Executive summary:

Single oral application of 200 mg/kg bw diluted in polyethylene glycole was given to male and female Wistar rats by gavage. Since all females that received 2000 mg/kg bw, died, no males were tested with this dose. Signs of intoxication before death were "spasmic-jumping behaviour" ; 200 mg/kg bw was tolerated by males and females without symptoms. Body weight development was not influenced at the dose of 200 mg/kg bw in both sexes. Post mortem exanination was without findings in 200 mg/kg bw males and females but females that had received 2000 mg/kg bw, showed yellow fluid in the stomach and reddened mucosa in stomach and lungs.The approximately LD50 value for female rats was 632 mg/kg bw and the LD50 value for male rats was >200 mg/kg bw (Bayer AG.1995)