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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A test group consisting of 5 animals/sex was treated by single dermal application of the test substance. No more than 16 hours prior to the dermal applications, the backs of the rabbits were shaved free of hair with electric clippers. On the testing day, the dermal applications (200 mg/kg bw) of the test material were made in undiluted form on the exposure sites (ca. 50 cm²) of the rabbits. After application, the exposure site was covered by wrapping the trunk of the animal with an parchment paper which was securely taped in place. The test material remained in contact with the skin for 24 hours. Observations for mortality, local reactions, and behavioral abnormalities were continued for a total of 5 days following the skin applications.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
N-ethylpropylamine
EC Number:
243-573-4
EC Name:
N-ethylpropylamine
Cas Number:
20193-20-8
Molecular formula:
C5H13N
IUPAC Name:
N-ethylpropan-1-amine
Details on test material:
- Name of test material (as cited in study report): Aethylpropylamin
- Physical state: liquid
- Analytical purity: 99 %

Test animals

Species:
rabbit
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2-3 kg
- Housing: individually
- Diet: Standard-pellet feed for rabbits ad libitum
- Water: tap water ad libitum
- Acclimation period: > 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 55 ± 10 %
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 7 x 7 cm = ca. 50 cm²
- Type of wrap if used: The exposure site was covered by wrapping the trunk of the animal with a parchment paper which was securely taped in place (Gazofix, No. 2938, Beiersdorf)
Duration of exposure:
24 h
Doses:
200 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 5 days
- Frequency of observations: 1 h, 24 h, 48 h, 72 h
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 200 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality observed. Exposed area was leathery, coarse, dry and heavy scabbed with a dark red to black colour (5 days post-application).
Mortality:
No mortality occurred.
Clinical signs:
other: 5 days post application the exposed area is leathery, coarse, dry and heavy scabbed with a dark red to black colour.
Gross pathology:
not performed

Applicant's summary and conclusion

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