Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study data over 12 years old provided by ECHA, on a previously notified substance considered comparable and suitable for read-across use for the substance being registered (see attachments for justification of read-across). Study conducted in accordance with generally accepted scientific principles, possibly with incomplete or methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Identification: AMIDE#71

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Wistar strain Crl:(WI) BR

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females at 2000 mg/kg bw
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

Observations were made for mortality, signs of toxicity, and effects on organs at necropsy.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred at 2000 mg/kg.
Male: 2000 mg/kg bw; Number of animals: 5; number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; number of deaths: 0
Clinical signs:
No clinical signs of toxicity were observed.
Gross pathology:
Effects on organs: No abnormalities were found in the animals at macroscopic post mortem examination.
Other findings:
None.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 of the test material in the Wistar strain rats (male and female) was determined to be greater than 2000 mg/kg bodyweight.
Executive summary:

Acute oral

The test substance was assessed for acute oral toxicity according to EU Method B1.

No mortality occurred at 2000 mg/kg and no clinical signs of toxicity were observed. No abnormalities were found in the animals at macroscopic post mortem examination. 

The acute oral LD50 of the test material in the Wistar strain rats (male and female) was determined to be greater than 2000 mg/kg bodyweight.