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Toxicological information

Acute Toxicity: oral

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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:
guideline study
Justification for type of information:
To minimize the number of animals, the up and down procedure adopted by OECD (2008a) for acute toxicity testing strives to use a maximum of five animals, starting with a single dose to a single rat. After a period of observation, the dose may or may not be adjusted up or down before dosing the next animal. As the test substance is not expected to have potent toxicity, the intent of this study was to test at the maximum dose of 2000 mg/kg bw. Thus, this test is characterized as a limit test.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Version / remarks:
Up and Down Procedure
Deviations:
no
GLP compliance:
yes
Test type:
up-and-down procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Remarks:
particle size: 0.5–10 μm
Details on test material:
manufactured by Epitech Group Srl, Milano Italy, supplied by Prismic

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
Sprague-Dawley rats (Vivo Bio Tech Ltd), age: 6–7 weeks

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
5 females Sprague-Dawley rats were used for the study.
Observation of clinical signs: at 10, 30 min, 1, 2, and 4 h after dosing, and thereafter daily until day 15. Each animal was subjected to gross pathology.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
The test substance did not induce any mortality at the limit dose of 2000 mg/kg bw.
Clinical signs:
No abnormal clinical signs were noted in any of the five test animals observed at 10 and 30 min, 1, 2, and 4 h, and thereafter daily until day 15 postdosing.
Body weight:
Not specified.
Gross pathology:
No gross pathological abnormalities were found.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the LD50 of the test substance was >2000 mg/kg bw after single oral administration to Sprague-Dawley rats.
Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance in female Sprague-Dawley rats using the “Up and Down Procedure” according to OECD Guideline 425 (2008a). As the substance was not expected to have potent toxicity, it was administered at the maximum dose of 2000 mg/kg bw (limit test) to 5 female rats. The test substance did not induce any mortality or abnormal clinical signs in any of the animals observed at 10 and 30 min, 1, 2, and 4 h, and thereafter daily until Day 15 post-dosing. Each animal was subjected to gross necropsy and no gross pathological abnormalities were found. Microscopic pathology was not conducted in the absence of any gross pathological changes. Under the study conditions, the LD50 of the test substance was >2000 mg/kg bw after single oral administration to Sprague-Dawley rats (Nestmann, 2017).