Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997-02-04 - 1997-04-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Dept. of Environment, Lower Saxony, Germany
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid - liquid: suspension
Details on test material:
Batch number: B97S1957c
Content: 67%
MEATG

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Source: Fa. Harlan Winkelmann GmbH, 33178 Borchen, Germany
Strain: Hsd/Dpb:WU
Weight range at study initiation: 213-298g (m), 179-205g (f)
Housing: collective housing up to a maximum of 3 animals per cage (Makrolon type III)Illumination: artificial lighting from 7.00 a.m.-7.00 p.m.
Temperature: 22±3 °C
Relative humidity: 30-70

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
140, 168, 202, 242, 290 and 348mg/kg of the test substance.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Clinical observations were conducted at regular intervals during the 14-day observation period.
Gross pathological examinations were performed immediately on animals found dead and at termination on day 14 on surviving animals.
Body weights were measured at days 0, 7 and 14.

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
318 mg/kg bw
Based on:
test mat.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
181 mg/kg bw
Based on:
test mat.
Mortality:
19 of 42 animals died pre-terminally.
Clinical signs:
Severe dose-dependent clinical signs were observed. The most striking findings were reduced activity, squatting position, abnormal galt and abnormal body posture, decreased body tone and decreased respiratory rate.
Body weight:
Weight gains were normal in all surviving animals.
Gross pathology:
Gross pathological examinations on day 14 post administration (terminal necropsy) revealed no test article-dependent findings. However, animals found dead showed alterations, which were considered to be test article-related.

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
MeaTG can be classified as toxic (Acute Tox 3).