2-amino-2-methylpropane-1,3-diol

Acute Toxicity: oral

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

Guideline:

EPA OTS 798.1175 (Acute Oral Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-aminopropane-1,3-diol

EC Number:

208-584-0

EC Name:

2-aminopropane-1,3-diol

Cas Number:

534-03-2

Molecular formula:

C3H9NO2

IUPAC Name:

2-amino-1,3-propanediol

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:

other: 10/10 animals displayed piloerection and lethargy

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.