Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

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 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

Constituent 1
Chemical structure
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
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Substance-ID: 78/701

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
Key result
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:
Necrosis 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