Registration Dossier

Administrative data

Description of key information

In a skin irritation study, the test item was found to be a skin corrosive. In addition, it was also classified a severely eye damaging.

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No GLP study no OECD and EU guidelines were followed.
Reference:
Composition 0
Qualifier:
equivalent or similar to
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 information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Details on test animals 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

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
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
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
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
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) .
Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

skin irritation:

In a key skin irritation study, six New Zealand White rabbits were treated once with cyclopentylamine (conentration: 0.5 mL) via occlusive exposure for 4 hours and observed irritation effects for 48 hours. 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".


Justification for selection of skin irritation / corrosion endpoint:
Only one key study is available.

Justification for selection of eye irritation endpoint:
In accordance with column 2 of REACH Annex VIII, the test eye irritation (required in section 8.2) does not need to be conducted if the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes, or the substance is flammable in air at room temperature.

Based on the results, the substance was classified and labelled as Skin Corr. 1B ( H314: Causes severe skin burns and eye damage.) and Flammable liquid cat 2 H225 Highly flammable liquid and vapour according to Regulation (EC) No 1272/2008 and as C; R34 Causes burns. and F, R11 Highly flammable. according to Directive 67/548/EEC (DSD).

Effects on skin irritation/corrosion: corrosive

Justification for classification or non-classification

Based on the results for skin irritation, the substance was classified and labelled as corrosive to the skin cat. 1B (H314: Causes severe skin burns and eye damage) according to Regulation (EC) No 1272/2008 and as corrosive (C, R34: Causes burns) according to Directive 67/548/EEC (DSD).