Registration Dossier

Administrative data

Description of key information

Skin irritation/corrosion

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 (Guillot, 1990).

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.


Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand Red
Details on test animals 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
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

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
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
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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

According to CLP, the test substance MONO-n-HEPTYLAMINE should be considered classified corrosive 1C.