Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
no data on content available in the report

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: male7-8 weeks; female 9 weeks
- Fasting period before study: 16 hours prior to treatment
- Weight at study initiation: male ca 175 g; female ca 161 g
- Housing: in groups of 5
- Diet ad libitum
- Water . ad libitum
- Acclimation period: at keast 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Single oral application of 2000 mg/kg bw by gavage
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
10 (5 males and 5 females)
Control animals:
no
Details on study design:
single oral application by gavage and observation of the animals for mortality, clinical signs and body weight development for 14 days. After termination the animals were examened gross-pathologically
Statistics:
the LD 50 was calculated according to the Method of "Moving averages" (Spärman and Kärber)

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: treatment was tolerated without mortality
Mortality:
0/10
Clinical signs:
no clinical signs
Body weight:
all animals gained weight
Gross pathology:
no gross pathological findings

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute toxicity of the test substance was evaluated according to the OECD TG 401 and GLP. 2000 mg/kg bw was applied to groups of 5 male and 5 female Wistar rats by gavage. No mortality occurred and no clinical signs were observed during the 14 -day observation period. Gross pathological examination after termination of the study did not show any findings which could be attributed to treatment. Thus. the LD50 is >2000 mg/kg bw. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.
Executive summary:

The acute toxicity of the test substance was evaluated according to the OECD TG 401 and GLP. 2000 mg/kg bw was applied to groups of 5 male and 5 female Wistar rats by gavage. No mortality occurred and no clinical signs were observed during the 14 -day observation period. Gross pathological examination after termination of the study did not show any findings which could be attributed to treatment. Thus. the LD50 is >2000 mg/kg bw. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.