Cyclopentylamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: No GLP study no OECD and EU guidelines were followed.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

Method: according to Federal Register Volume 37, No. 244, December, 1972 (intactand abraded skin, 4h, occlusive)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Cyclopentylamine

EC Number:

213-697-3

EC Name:

Cyclopentylamine

Cas Number:

1003-03-8

Molecular formula:

C5H11N

IUPAC Name:

cyclopentanamine

Test material form:

other: liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Sutton Bonington, Nr . Loughborough, Leicestershire
- Weight at study initiation: 2 .0 - 3 .0 kg
- Housing: Animals were housed individually in suspended metal cages.
- Diet: ad libitum, Rabbit Diet, supplied by John Waring Limited, Shardlow, Derbyshire
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 + 3°C
- Air changes (per hr): 20 air changes per hour
- Photoperiod (hrs dark / hrs light): 14 hours light, 10 hours dark

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

4, 24 and 48 hours

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 50 mm x 50 mm
- Type of wrap if used: a composite patch


SCORING SYSTEM: according to Draize j. H. 1959

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 48 h

Remarks on result:

other: intact site

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 48 h

Remarks on result:

other: abraded site

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48 h

Score:

1.83

Max. score:

4

Reversibility:

not fully reversible within: 48 h

Remarks on result:

other: intact site

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48 h

Score:

1.67

Max. score:

4

Reversibility:

not fully reversible within: 48 h

Remarks on result:

other: abraded site

Irritant / corrosive response data:

The test material produced severe cutaneous irritation at both intact and abraded sites of all test animals. At 4 hours all test sites had become necrotic. The skin had become hard to touch and black in colour with slight oedema around the periphery. At 24 hours all test sites were covered with a hard black crust which was consistent with irreversible tissue destruction (necrosis). Similar effects were apparent at the 48 and 96 hour readings. The test material produced tissue necrosis at 6/6, intact and 6/6 abraded sites and was defined as being a "corrosive substance". In addition, it was also defined as a severe skin irritant (primary irritation index 5 .8) .

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: EU