Octylamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

Cited as Directive 84/449/EEC, B.4

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

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

Details on test material:

1-Octanamine
- Name of test material (as cited in study report): Genamin 8 R 100 D
- Analytical purity approx. 99 %

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG
- Weight at study initiation: 2.1 - 2.2 kg
- Housing: singly
- Diet: ad libitum
- Water: ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20*/- 3°C
- Humidity (%): 50 +/-20%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

3 minute(s)

Observation period:

1, 24, 48. and 72 hours, 7, 14, and 21 days post treatment

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage:
- Type of wrap if used: gauze, held inpalce by cotton wrap


REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm water
- Time after start of exposure: 3 minutes


SCORING SYSTEM: table contained in OECD TG 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.44

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Remarks on result:

other: scoring was only possible adjacent to the treated site, due to coloring and severe corrosion of the treated skin

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.22

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Remarks on result:

other: scoring was only possible adjacent to the treated site, due to coloring and severe corrosion of the treated skin

Irritant / corrosive response data:

After 3 min, the skin showed severe burns, with green-brown staining within 30 - 60 min.
After 1 h, the treated area hardened, was swollen and turned dark red to black. The injured skin area was sharply demarcated from the healthy skin with erythema and edema at the transition line.
At 14 and 21 days post treatment, the skin was dry, rough and crusty. New skin had formed which was parchment-like and scarred.

Applicant's summary and conclusion

Interpretation of results:

Category 1A (corrosive)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

After a 3 minute contact period, N-octylamine caused irreversible skin corrosion in all three treated rabbits.

Executive summary:

The skin irritating properties of n-octylamine were examined in a GLP OECD TG 404 study using 3 rabbits. 0.5 mL of the neat test substance were applied to the shaved intact dorsal skin and washed off after 3 minutes. The skin reactions were recorded at 1, 24, 48, and 72 hours after treatment, and thereafter at 7, 14, and 21 days.

The skin reactions adjacent to the treated sites were evaluated according to the table contained in OECD TG 404, because the skin at the treated sites was colored and did not allow evaluation at all readings up to 72 hours. After 1 h, the treated area hardened, was swollen and turned dark red to black. The injured skin area was sharply demarcated from the healthy skin with erythema and edema at the transition line. At 14 and 21 days post treatment, the skin was dry, rough and crusty. New skin had formed which was parchment-like and scarred. Overall, n-octylamine was highly corrosive to the rabbit’s skin as it caused irreversible skin corrosion after a 3-minute contact period (Hoechst, 1984).