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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From April 30 to May 15, 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Source study has reliability 2. Details on the read across are attached in section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Male and female rats were administered the test substance at 5000 mg/kg bw by oral gavage. The application was followed by a 14-d observation period and thereafter the animals were sacrificed.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Breeder: Winkelmann, Borchen
Age: ca. 8 weeks old
Body weight: 153 -157 g
Temperature and relative humidity: 22 ± 1.5 °C and 60 ± 5 %, respectively
Light period: 12 h light - 12 h dark
Feed: Altromin R 1324

Administration / exposure

Route of administration:
oral: drinking water
Vehicle:
water
Details on oral exposure:
The test substance was diluted into water and administered at a constant rate by gavage. Animals did not have access to feed and water from 16 h before to 4 h after application.
Doses:
20 ml/kg (5000 mg/kg bw)
No. of animals per sex per dose:
5
Details on study design:
This was followed by a 14-d observation period. At the end of the study, animals were sacrified and an anatomo-pathological examination was done.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
None of the animals died during the study period.
Clinical signs:
No clinical symptoms were observed.
Gross pathology:
After the anatomo-pathological examination, no signs of toxicity were detected.

Applicant's summary and conclusion

Interpretation of results:
other: not classified within the CLP Regulation (EC 1272/2008)
Conclusions:
No mortality occurred at the dose of 5000 mg/kg, thus no LD50 could be determined.
Executive summary:

Method

Acute oral toxicity was assessed as limit test in rats; no guideline was specified. Male and female rats were dosed with test substance at concentration of 5000 mg/kg bw by oral gavage. The application was followed by a 14 -d observation period. At the end of the study, animals were sacrificed and a gross pathological examination was conducted.

Results

No deaths, no clinical symptoms during the observation period and no signs of toxicity at necropsy were recorded. Therefore, LD0 = 5000 mg/kg bw, LD50 > 5000 mg/kg bw.