Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Study conducted similarly to OECD Guideline 401 with deviations: purity of test item not reported; source of animals and environmental conditions not reported; acclimation period not reported; animals were not weighed after dosing; gross pathology not reported
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
purity of test item not reported; source of animals and environmental conditions not reported; acclimation period not reported; animals were not; gross pathology not reported
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
340, 670, 1310, 2560 and 5000 mg/kg bw
No. of animals per sex per dose:
10 /dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Observations for mortality were made daily for 14 days.
- Necropsy of survivors performed: Yes; all surviving animals were sacrificed for gross necropsy examination.
Statistics:
None

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
890 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Deaths occurred at day 13 (1 animal) and 14 (2 animals) following administration of test item at the dose of 670 mg/kg bw, and overnight (4 animals), Day 1 (2 animals) and Day 2 (1 animal) following administration of test item at 1310 mg/kg bw
Mortality:
- Deaths occurred overnight to 14 days following administration of test item.
- 1/10, 3/10, 7/10, 10/10 and 10/10 animals died at 340, 670, 1310, 2560 and 5000 mg/kg bw, respectively.
Clinical signs:
diarrhea at 670 mg/kg, lethargy and flaccid rats at 1310 mg/kg, and lethargy, diarrhea and flaccid rats at 5000 mg/kg were observed
Body weight:
- No data
Gross pathology:
- No data
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The oral LD50 for Nopol was evaluated to 890 mg/kg bw in rats which is higher than 300 mg/kg bw and lower than 2000 mg/kg bw by oral route in the rat.
According to Regulation EC No. 1272/2008 and according to GHS criteria, the test item has to be classified in category 4. The signal word “Warning” and hazard statement H302 “Harmful is swallowed” are required.
Executive summary:

In an acute oral toxicity study performed similarly to Guideline OECD 401, groups (10 /dose) of rats were given a single oral dose of Nopol at 340, 670, 1310, 2560 and 5000 mg/kg bw. Animals were then observed for mortality and clinical signs for 14 days and all survivors were sacrificed for macroscopic examination.

Diarrhea, lethargy and flaccid rats were observed. Deaths occurred overnight to 14 days following administration of the test item. 1/10, 3/10, 7/10, 10/10 and 10/10 animals died at 340, 670, 1310, 2560 and 5000 mg/kg bw, respectively.

In this study, the oral LD50 of the test item was 890 mg/kg bw.

The oral LD50 for Nopol was evaluated to 890 mg/kg bw in rats which is higher than 300 mg/kg bw and lower than 2000 mg/kg bw.

According to Regulation EC No. 1272/2008 and according to GHS criteria, the test item has to be classified in category 4. The signal word “Warning” and hazard statement H302 “Harmful is swallowed” are required.