D-Gluconic acid, δ-lactone, reaction products with propanolamine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Only short summary of the BASF study available

Justification for type of information:

3-aminopropan-1-ol is one of the constituents of Reaction mass of 3-hydroxypropan-1-aminium D-gluconate and N-(3-hydroxypropyl)-D-gluconamide.at a molar ratio of 1:1. The process used is a pseudo acid – base reaction in water that leads always to a mixture of the “amide” and the “salt” part. Both entities are required for the applications performances. With the manufacturing process used here it is not possible to separate the amide and salt part from the water phase. The 3-aminopropan-1-ol is the kation of the salt part.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

3 male and 3 female animals were subjected to a limit test. The test substance was applied to a 2.5 x 2.5 cm application site of white Vienna rabbits for 20 h under occlusive conditions. The skin was either intact or abraded. After the application time, the skin was washed with water which may have contained a mild detergent. Animals were observed for 8 days and skin changes were observed on working days. Findings were recorded and graded as described in OECD test guideline 404.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-aminopropan-1-ol

EC Number:

205-864-4

EC Name:

3-aminopropan-1-ol

Cas Number:

156-87-6

Molecular formula:

C3H9NO

IUPAC Name:

3-aminopropan-1-ol

Details on test material:

- Name of test material (as cited in study report): 3-Aminopropanol; Substance ID 78/701
- no further details given

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Wiga
- Weight at study initiation: average weight male animals: 210 g; female animals: 183 g

Administration / exposure

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 48 cm²

TEST MATERIAL
- Amount applied: 2.02 ml/kg bw

Duration of exposure:

not applicable, test substance was not washed off 24 hours after application as recommended in the OECD guideline 402.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 male and 3 female animals were used

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days

Statistics:

not applicable

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

no deaths occurred

Clinical signs:

no signs of general toxicity could be observed;

Body weight:

mean weight male animals: day 0: 210 g, day 4: 202g, day 6: 220 g, day 8: 227 g, day 11: 239 g, day 13: 238 g
mean weight female animals: day 0: 183 g; day 4: 179 g, day 6: 193 g, day 8: 197 g, day 11: 198 g, day 13: 192 g

Gross pathology:

Skin necrosis pathologically confined

Other findings:

Necroses were observed at the site of applicatation on the day following substance application.

Any other information on results incl. tables

The skin irritation properties of the test substance seem to be the limiting factor of acute dermal toxicity. No further clinical signs of toxicity were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

For rats exposed to 3-aminopropan-1-ol, the LC50 for dermal exposure is > 2000 mg/kg bw.