Registration Dossier

Administrative data

Description of key information

The test material was classified as corrosive to rabbit skin. Due to this fact, it is assumed that the test substance also causes severe damage to the eyes. A study was not conducted to support this assumption due to animal welfare reasons.

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:
1991-11-06 - 1991-11-09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline compliant study.
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.27 - 2.55 kg
- Housing: individually in suspended metal cages
- Diet: standard laboratory diet, ad libitum (Spillers Rabbit Diet, Dalgety Agriculture Ltd., Almondsbury, Bristol)
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 21
- Humidity (%): 49 - 63
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: Non treated skin served as a control.
Amount / concentration applied:
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
up to 72 hours after removal of patch.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 5 cm2
- Type of wrap if used: elasticated corset (TURBIGRIP)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with distilled water
- Time after start of exposure: 4hours later

SCORING SYSTEM:
Erythema and Eschar Formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation(inujuries in depth) 4

Oedema Formation
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approx. 1 mm) 3
Severe oedema (raised more than 1 mm and extending beyond the area of exposure) 4
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: well defined erythema
Irritant / corrosive response data:
Adverse reactions prevented accurate evaluation of erythema and oedema at all treated skin sites at the 24, 48 and 72-hour observations. The treatment sites were assigned a grade 4 for erythema on the Draize scale due to injuries in depth.
Interpretation of results:
Category 1C (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

Additional information

Skin irritation

The skin irritation potential of the test item was assessed according to OECD guideline 404 and EU method B.4. A single 4 -hour, semi-occluded application of the test material to the intact skin of three New Zeland White rabbits produced corrosive effects. The reactions included dermal necrosis, severe oedema and scabbing. The animals were killed for humane reasons immediately after the 72 -hour observation. The test substance was classified as corrosive to the skin.


Justification for selection of skin irritation / corrosion endpoint:
GLP and guideline compliant study.

Effects on skin irritation/corrosion: corrosive

Justification for classification or non-classification

According to Annex I of the Directive 67/548/EEC and according to Annex VI 1272/2008 CLP (UN GHS) the test substance is classified as irritating to skin (R38; Skin corrosion/irritation Cat. 2) and irritating to eyes (R36; Serious eye damage/eye irritation Cat. 2A). However, based on the results of the skin irritation study in rabbits (Safepharm Lab., 1991), the test substance is considered to be corrosive to skin and eyes. Therefore, the following classification of the test substance is suggested (self-classification):

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is considered to be classified as corrosive C, R34 (Causes burns) under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.

 

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is considered to be classified as cat. 1C (H314: Causes severe skin burns and eye damage) under Regulation (EC) No. 1272/2008, as amended for the sixth time in Regulation EC 605/2014.