Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
The study was conducted in August 1974.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Reliability 2 is assigned because although the study was conducted similar to the current OECD TG 401, the guideline is not referenced and the study is non-GLP. However, this did not influence the reliability of the results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Test material form:
solid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ace Animals
- Weight at study initiation: 235-287 g
- Fasting period before study: 16-20 hours
- Housing: 5/cage in suspended wire mesh cages. Bedding was placed beneath the cages.
- Diet: fresh Purina Rat Chow (Diet #5012), ad libitum, except 16-20 hours prior to dosing
- Water: ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
The following doses were used in the study: 1310, 1640, 2050, 2560 and 5000 mg/kg bw.
No. of animals per sex per dose:
10 males/dose
Control animals:
no
Details on study design:
- Frequency of observations: Animals were observed 3-4 hours post dosing and once daily thereafter for 14 days for mortality, toxicity and pharmacological effects.
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, toxicity and pharmacological effects.

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
2 000 mg/kg bw
Based on:
test mat.
95% CL:
> 1 840 - < 2 160
Mortality:
The following numbers of animals died during the study, at the doses of:
- 1310 mg/kg bw: 0/10
- 1640 mg/kg bw: 4/10 (2 on day 1 and 2 on day 2)
- 2050 mg/kg bw: 6/10
- 2560 mg/kg bw: 9/10
- 5000 mg/kg bw: 10/10.
Clinical signs:
Lethargy was noted in rats at the 3 higher doses.
Other findings:
No other findings were noted.

Applicant's summary and conclusion

Interpretation of results:
other: Classified as Acute Category 4
Remarks:
According to EU CLP 1272/2008 and its amendments.
Conclusions:
Acute oral toxicity was performed equivalent to the guideline OECD TG 401. The acute oral LD50 for the substance in male rats was determined to be 2000 mg/kg bw. Based on the results of this study, in accordance with EU CLP 1272/2008 criteria, the test substance needs to be classified as Category 4. The test substance needs to be classified according to GHS criteria as Category 4 as well.
Executive summary:

An acute oral toxicity study was performed according to the guideline OECD TG 401. Ten male rats were administered the substance at dose levels of: 1310, 1640, 2050, 2560 and 5000 mg/kg bw. No rat died at the dose of 1310 mg/kg bw, four died at 1640 mg/kg bw, six at 2050 mg/kg bw, nine at 2560 mg/kg bw and ten at 2000 mg/kg bw. The clinical signs observed was lethargy at 3 higher doses. The acute oral LD50 for the substance in male rats was determined to be 2000 mg/kg bw.