Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1)
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
2002
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
1992
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Version / remarks:
1998
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Germany
- Age at study initiation: at least 6 weeks old
- Weight at study initiation: at least 1.0 kg
- Housing: Individually in labelled cages with perforated floors
- Diet (e.g. ad libitum): Standard Laboratory rabbit diet, approx. 100 g per day. Pressed hay provided twice per week
- Water (e.g. ad libitum): Free access to tap-water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12h dark/12h light

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.4mL
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
1
Details on study design:
TEST SITE
- Area of exposure: 150sq.cm
- Type of wrap if used: Metalline patch 2 x 3 cm. Patch mounted on micropore tape wrapped with Coban elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) hours

SCORING SYSTEM:
- Method of calculation: using numerical scoring system in table 1 below
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
probability of severe irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
probability of severe irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
probability of severe irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Max. score:
4
Reversibility:
not reversible
Remarks on result:
not determinable
Remarks:
Not scored due to eschar formation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Max. score:
4
Remarks on result:
not determinable
Remarks:
Not scored due to eschar formation
Irritant / corrosive response data:
On 25% of the treated surface, black discolouration of the skin (a sign of necrosis) was present after 1 and 24 hours, resulting in eschar formation. A thick black scab was noted after 72 hours. Erythema score 4 was indcated for the aforementioned skin effects. Reactions seen in the remaining skin area (75%) resulted in erythema scores between well defined and moderate to severe erythema. Scoring of oedema was not possible after 48 and 72 hours due to eschar formation and/scab formation.
Other effects:
The animal was sacrified for humane reasons after 72 hours based on the severity of the skin effects, and no other animals treated.

No staining of the treated skin by the test substance was observed.

No symptoms of systemic toxicity were observed in the animal during the test period.
Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Remarks:
Not possible to sub-categorise based on data available
Conclusions:
This substance is corrosive to skin under the conditions of the test.
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Name:
3-(R)-Quinuclidinol
Implementation:
EU
Type of classification:
self-classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
hazard class not assessed
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Hazard category:
Flam. Solid 1
Hazard statement:
H228: Flammable solid.
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data lacking
Reason for no classification:
data conclusive but not sufficient for classification
Hazard category:
Acute Tox. 4
Hazard statement:
H302: Harmful if swallowed.
Reason for no classification:
data lacking
Reason for no classification:
data lacking
Hazard category:
Skin Corr. 1
Hazard statement:
H314: Causes severe skin burns and eye damage.
Hazard category:
Eye Damage 1
Hazard statement:
H318: Causes serious eye damage.
Reason for no classification:
data lacking
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data lacking
Reason for no classification:
data lacking
Reason for no classification:
data lacking
Reason for no classification:
data lacking
Reason for no classification:
data lacking
Reason for no classification:
data lacking
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Signal word:
Danger
Code:
GHS02: flame
Code:
GHS05: corrosion
Code:
GHS07: exclamation mark
Hazard statement:
H228: Flammable solid.
Hazard statement:
H302: Harmful if swallowed.
Hazard statement:
H314: Causes severe skin burns and eye damage.
Precautionary statement:
P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
Precautionary statement:
P240: Ground and bond container and receiving equipment.
Precautionary statement:
P241: Use explosion-proof [electrical/ventilating/lighting/...] equipment.
Precautionary statement:
P280: Wear protective gloves/protective clothing/eye protection/face protection/hearing protection/...
Precautionary statement:
P370+P378: In case of fire: Use... to extinguish.
Precautionary statement:
P264: Wash ... thoroughly after handling.
Precautionary statement:
P270: Do not eat, drink or smoke when using this product.
Precautionary statement:
P301+P310: IF SWALLOWED: Immediately call a POISON CENTER/doctor/…
Precautionary statement:
P330: Rinse mouth.
Precautionary statement:
P302+P352: IF ON SKIN: Wash with plenty of water/…
Precautionary statement:
P332+P313: If skin irritation occurs: Get medical advice/attention.
Precautionary statement:
P362: Take off contaminated clothing.
Precautionary statement:
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
Precautionary statement:
P337+P313: If eye irritation persists: Get medical advice/attention.
Precautionary statement:
P501: Dispose of contents/container to ...

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion