C16-18-(even numbered, saturated and unsaturated)-alkylamines

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study according to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according 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:

(Z)-octadec-9-enylamine

EC Number:

204-015-5

EC Name:

(Z)-octadec-9-enylamine

Cas Number:

112-90-3

Molecular formula:

CH3(CH2)7CH=CH(CH2)7CH2NH2

IUPAC Name:

octadec-9-en-1-amine

Constituent 2

Reference substance name:

Oleyl Alkylamines

IUPAC Name:

Oleyl Alkylamines

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Weight at study initiation: approx. 2.8 kg
- Housing: polystyrene cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3 °C
- Humidity (%): 50 +/- 20
- Air changes (per hr): approx. 12
- Photoperiod (hrs dark / hrs light): 12 hours periodically

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin served as control

Amount / concentration applied:

0.5 mL/patch

Duration of treatment / exposure:

3 min (left flank)
4 h (right flank)

Observation period:

1, 24, and 48h after patch removal (when severe irritant effects were observed the test was immediately terminated and the animals were killed on
humane grounds).

Number of animals:

1

Details on study design:

TEST SITE
- Area of exposure: left and right flank
- % coverage: approx. 6cm²

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

3 min exposure

Time point:

other: 1h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

3 min exposure

Time point:

other: 1h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 3

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

3 min exposure

Time point:

other: 24h

Score:

3

Max. score:

3

Reversibility:

fully reversible

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

3 min exposure

Time point:

other: 24h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 5

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

4h exposure

Time point:

other: 1h

Score:

2

Max. score:

2

Reversibility:

not reversible

Results 6

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

4h exposure

Time point:

other: 1h

Score:

4

Max. score:

4

Reversibility:

not reversible

Results 7

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

4h exposure

Time point:

other: 24h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: necrosis

Results 8

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

4h exposure

Time point:

other: 24h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: necrosis

Irritant / corrosive response data:

The test item caused moderate to severe erythema and edema to the intact skin after a treatment period of 3 minutes and 4h. After 4h treatment the test material procuced epidermal necrosis indivative of corrosivity to the skin.

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the study results the test material has to be considered as corrosive to skin.

Executive summary:

In an OECD TG 404 study, 0.5 ml the test material "Noram O" (oleylamine), a light brown, translucient and pasty liquid (purity 97.7%), was applied semi-occlusively for 3 minutes (left flank) and 4 hours (right flank) to the shaved skin of one New Zealand White Rabbit. The substance was applied as delivered by the sponsor onto a 6 cm²gauze pad, which was then applied to the right flank. The skin was examined 1 hour, 24, and 48 hours after removal of the dressing. Following the 3 minute exposure moderate to severe erythema and edema but no necrosis were observed. Following 4 hour exposure average Draize scores after 24 hours were 4.0 for erythema and 4.0 for oedema. At the same time necrosis was noted and the study was terminated for humane reasons.