Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Overall reporting of study is limited, but sufficient information to judge on hazard potential
Justification for type of information:
See attached (in chapter 13 of IUCLID) document with the justification for the category/read-across approach.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OTS 798.1175 (Acute Oral Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): Serinol (APD-1,3)

Specific details on test material used for the study:
- Name of test material (as cited in study report): APD-1, 3
- Lot/batch No.: 227-124
- Analytical purity: No data

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
not specified

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Dosing solution was prepared by dissolving 5 g test material per 10 ml water (USP sterile water for injection).
Doses:
5 g/kg bw
No. of animals per sex per dose:
10 animals (sex not indicated)
Control animals:
no
Details on study design:
Animals dosed and then returned to cages for observation until day 14. Bodyweights were determined prior to dosing and on day of sacrifce (prior to euthenasia). All animals necropsied at sacrifice.

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
4 out of 10
Clinical signs:
10/10 animals displayed piloerection and lethargy
Body weight:
no changes reported
Gross pathology:
Discoloration of the kidneys, liver, spleen and small intestine and signs of hemorrhaging in the stomach observed in the 4 animals that died.
Other findings:
none

Any other information on results incl. tables

Four rats (4/10) died within 24 hours following administration of the Limit Dose of 5 g/kg. Abnormal clinical signs were observed in all (10/10) animals which included piloerection and lethargy. The four animals that died showed abnormal signs at gross necropsy including discoloration of the kidneys, liver, spleen and small intestine and signs of hemorrhaging in the stomach.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance, APD-1, 3 LOT #: 227-124, was evaluated for its potential to produce death following oral administration at a dose of 5 g/kg in male and female Sprague- Dawley rats. Based on the mortality (4/10 animals) in the Limit Test, the test substance is not classified for acute oral toxicity.