2-aminopropane-1,3-diol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1995

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: 40 CFR, Part 798, Subpart B Section 798.1100, Toxic Substances Control Act, 1985

Deviations:

no

GLP compliance:

not specified

Test type:

standard acute method

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-aminopropane-1,3-diol

Details on test material:

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

Test animals

Species:

rabbit

Strain:

not specified

Sex:

male/female

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

other: test substance was moistened with water prior to application.

Details on dermal exposure:

TEST SITE
- % coverage: At least 10% of the body surface
- Type of wrap if used: The test substance was held in contact with the skin with porous gauze dressing and non-irritating tape. The animals were wrapped with Vetrap bandaging for the 24 hour exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test sites were rinsed with USP sterile water for injection
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- For solids, paste formed: No. The test substance was moistened with water at the time of dosing.

Duration of exposure:

24 hours

Doses:

2000 mg/ kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for clinical signs, but the frequency was not reported. The animals were weight at least before administration of the test substance and at the end of the observation period.
- Necropsy of survivors performed: Yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There was no mortality during the study period.

Clinical signs:

other: None of the test animals exhibited clinical signs of toxicity during the course of the study.

Gross pathology:

No lesions were observed during the pathological examination.

Other findings:

Nine out of ten animals exhibited slight to defined erythema. One rabbit also exhibited edema at the 24 hour scoring point. It is not reported whether the lesions were reversible.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified