Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
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 corrosive to the skin
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Name:
LiPO2F2
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
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 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. 3
Hazard statement:
H301: Toxic if swallowed.
Hazard category:
Acute Tox. 4
Hazard statement:
H312: Harmful in contact with skin.
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 conclusive but not sufficient for classification
Reason for no classification:
data lacking
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:
STOT Rep. Exp. 1
Hazard statement:
H372: Causes damage to organs <or state all organs affected, if known> through prolonged or repeated exposure <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.
Affected organs:
other: Stomach, Kidney
Route of exposure:
oral
Reason for no classification:
data conclusive but not sufficient for classification
Hazard category:
Aquatic Chronic 2
Hazard statement:
H411: Toxic to aquatic life with long lasting effects.
Reason for no classification:
data conclusive but not sufficient for classification
Signal word:
Danger
Code:
GHS06: skull and crossbones
Code:
GHS05: corrosion
Code:
GHS09: environment
Hazard statement:
H411: Toxic to aquatic life with long lasting effects.
Hazard statement:
H301: Toxic if swallowed.
Hazard statement:
H314: Causes severe skin burns and eye damage.
Hazard statement:
H312: Harmful in contact with skin.
Hazard statement:
H372: Causes damage to organs <or state all organs affected, if known> through prolonged or repeated exposure <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.
Additional text:
Stomach, kidney
Precautionary statement:
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
Precautionary statement:
P264: Wash ... thoroughly after handling.
Precautionary statement:
P270: Do not eat, drink or smoke when using this product.
Precautionary statement:
P273: Avoid release to the environment.
Precautionary statement:
P280: Wear protective gloves/protective clothing/eye protection/face protection/hearing protection/...
Precautionary statement:
P301+P310: IF SWALLOWED: Immediately call a POISON CENTER/doctor/…
Precautionary statement:
P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting.
Precautionary statement:
P302+P352: IF ON SKIN: Wash with plenty of water/…
Precautionary statement:
P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower].
Precautionary statement:
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
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:
P310: Immediately call a POISON CENTER/doctor/…
Precautionary statement:
P330: Rinse mouth.
Precautionary statement:
P361: Take off immediately all contaminated clothing.
Precautionary statement:
P363: Wash contaminated clothing before reuse.
Precautionary statement:
P391: Collect spillage.
Precautionary statement:
P405: Store locked up.
Precautionary statement:
P501: Dispose of contents/container to ...
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)
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
other: Japanese White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kitayama LABES Co., Ltd
- Age at study initiation: 11 weeks old
- Weight at study initiation: 2.51 - 2.64 kg
- Housing: Hanging type aluminium cages (32W x 48D x 33H cm, stainless steel mesh flooring)
- Diet (e.g. ad libitum): Pellet diet, ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 1 day after 7 day quarantine period

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.9 - 24.1°C
- Humidity (%): 45.1 - 63.0 %
- Air changes (per hr): 6 - 20
- Photoperiod (hrs dark / hrs light): 12h dark, 12h light
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: olive oil
Controls:
yes, concurrent vehicle
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g test substance

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.15 mL
- Lot/batch no. (if required): 70910
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: dorsal area of the trunk
- coverage: approx 6cm2
- Type of wrap if used: semi-occlusive elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours

OBSERVATION TIME POINTS
1, 24, 48, 72 hours then 7, 10, 14 days

SCORING SYSTEM:
- Method of calculation: following the OECD guideline
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
not reversible
Remarks:
eschar formation was observed after 7 days and did not reverse by the end of the 14 day observation period
Remarks on result:
probability of severe irritation
Remarks:
Max score achieved on Day 7, 10 and 14 observations
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other:
Remarks:
no effect
Other effects:
- Other adverse local effects: Irreversible effects to the skin was observed in one animal during the study

No irritation was seen in the control animals (treated with olive oil) all scores zero.

Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
The substance is concluded to be corrosive/severly irritating to skin and therefore a classification of Skin Corrosion Category 1 is applied.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion