Heptylamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

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:

Heptylamine

EC Number:

203-895-8

EC Name:

Heptylamine

Cas Number:

111-68-2

Molecular formula:

C7H17N

IUPAC Name:

heptan-1-amine

Details on test material:

- Name of test material (as cited in study report): MONO-n-HEPTYLAMINE {C7A)
- Physical state: colorless liquid
- Analytical purity: 99,51%
- Lot/batch No.: LABORATOIRE L 8602

Test animals

Species:

rabbit

Strain:

New Zealand Red

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Bonen, 01400 Châtillon Sur Chalaronne, France
- Weight at study initiation: 2.3 kg
- Housing: individual housing, in polystyrene cages, of internal dimensions 560 x 355 x 315 mm, with a perforated floor.
- Diet: rabbit complete pelleted maintenance food, ad libitum
- Water: softened and filtered drinking water ad libitum
- Acclimation period: minimum of 5 days before the beginning of treatment.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C.
- Humidity (%): 30 to 70%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours after the removal of the semi-occlusive patch and of the hydrophilic gauze pad, and days 7 and 14.

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 2.4 cm square
- Type of wrap if used: crimped gauze bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): test article which had not penetrated was wiped away with a gauze pad moistened with distilled water (or a non-irritant solvant)
- Time after start of exposure: 4 hours

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24+48+72h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: superficial necrosis

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24+48+72h

Score:

2.67

Max. score:

4

Reversibility:

not reversible

Irritant / corrosive response data:

The test substance MONO-n-HEPTYLAMINE is corrosive

Applicant's summary and conclusion

Interpretation of results:

Category 1 (corrosive) based on GHS criteria

Remarks:

Migrated information

Conclusions:

After a 4-hour dermal application, under semi-occlusive dressing, the test substance MONO-n-HEPTYLAMINE may be considered corrosive.

Executive summary:

This study evaluates the degrees of Cutaneous Primary Irritation and Corrosivity induced by the test article MONO-n-HEPTYLAMINE, in the albino rabbit, after a single application.

A predetermined amount of the test article was applied once only to intact skin on the previously clipped back or one of the flanks of each rabbit of a same group. The MONO-n-HEPTYLAMINE is held in contact with the skin under a semi-occlusive patch for at least 4 consecutive hours. Then, the effects provoked 1, 24, 48 and 72 hours after the end of the contact period were observed, and a possible corrosive action of the test article was studied, characterised by the irreversibility of the lesions, by the observation of the animals over a longer period of time (Day 7 and Day 14 maximum).

The mean erythema score was 4 and the mean edema score was 2,67. Both were irreversible with superficial necrosis.

After a 4-hour dermal application, under semi-occlusive dressing, the test substance MONO-n-HEPTYLAMINE may be considered corrosive.