Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
No details of the method, procedure and results.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
White powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
Rat from breeding center IFFA/CREDO (Saint-Germain sur l'Arbresle - France)Mean Wieght : 150 gAge : 7 weeks

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: gommi arabicum
Details on oral exposure:
The substance is suspended in a 5% of solution of gommi arabicum using a homogenizer. It is administered at 10 am (1 ml for 100 g of bodyweight)
Doses:
Not specified
No. of animals per sex per dose:
Not specified
Control animals:
yes
Remarks:
with gommi arabicum (5%) - 1 ml for 100 g
Details on study design:
T° : 22°C +/- 2°CLighting is artificial : 12 hours light, 12 hours darkThe animals are randomly selected and kept in their cages for at least 5/6 days prior to the start of dosing to allow for acclimatisation to the laboratory conditions.Animals are group-caged by doseFood and water ad. libitumObservation during 14 days. All rats were weighed before the treatment and the 3, 7, 10 and 14 day after the treatment.
Statistics:
Bliss model

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 1 205.74 mg/kg bw
Based on:
test mat.
95% CL:
> 1 161.73 - < 1 251.42
Mortality:
Yes but the number is not specified
Clinical signs:
For the survivors, a sedative effect was observed which disappears after 2 days
Body weight:
No variation
Gross pathology:
Not specified

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The LD50 of the mephtamin (CAS : 139525-77-2) is 1205 mg/kgbw.
Executive summary:

On the basis of an experimental study, the LD50 for the oral route of the mephtamin (CAS : 139525-77-2) is 1205 mg/kgbw (wistar rat).