Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study under GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Octylamine
EC Number:
203-916-0
EC Name:
Octylamine
Cas Number:
111-86-4
Molecular formula:
C8H19N
IUPAC Name:
octan-1-amine

Test animals

Species:
rabbit
Strain:
other: New Zealand Albino
Details on test animals or test system and environmental conditions:
Species New Zealand albino rabbit
Origin Hoechst AG, Kastengrund
Number of animals 3
Body weight at start
of the study 2.1-2.2 kg
Animal maintenance in fully air-conditioned rooms in separate cages arranged in a battery
Room temperature 20 ± 3°C
Relative humidity 50 ±20 %
Lighting time 12 hours daily
Food Altromin 2123
Water water, deionisied, chlorinated from automatic water dispensers, ad libitum
Animal identification numbered ear tags

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
3 min
Observation period:
30-60min, 24h, 48h, 72h, 7d, 14d, 21d
Number of animals:
3
Details on study design:
About 24 hours before the start of the study the hair in the dorsal region of the body of 3 rabbits was removed with an electric clipper over an area of about 25 cm2. Only animals with intact skin were used.

Each animal was treated with 0.5 ml of undiluted 0.5 Octylamine. The substance was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster (specially produced by Beiersdorf Aktiengesellschaft). The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage.

The exposure period was 3 Minutes. After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water.

Examinations of the skin took place after 30 - 60 minutes as well as 24, 48 and 72 hours after removal of the patches. Because of persistent irritations 72 hours after removal of the patches, additional readings were performed after 7, 14 and 21 days.

Erythema, eschar formation and oedema were evaluated numerically. All other changes of the skin were recorded.

Results and discussion

In vivo

Irritant / corrosive response data:
30-60min after application the skin was hardened, bulged. Erythema- and Eschar formation could be detected.
24h after application the skin was discolored to black.
14d after application scar formation could be detected.

Applicant's summary and conclusion

Interpretation of results:
Category 1A (corrosive) based on GHS criteria
Remarks:
Migrated information
Conclusions:
Based on the results of this OECD404 study Octylamine is corrosive to skin.
Executive summary:

Based on the results of this OECD404 study Octylamine is corrosive to skin.

Categories Display