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Eye irritation

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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes
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)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
other: Japanese White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Japan Laboratory Animals, Inc.
- Age at study initiation: 18 weeks
- Weight at study initiation: 3.09 Kg
- Housing: Individually in aluminium cages.
- Diet (e.g. ad libitum): Free access to pelleted rabbit diet.
- Water (e.g. ad libitum): tap water
- Acclimation period: 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 25°C
- Humidity (%): 46 to 71%
- Air changes (per hr): 11 to 14 times per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:
Seperate exposures of 3 minutes, one hour and four hours also with a control area all on the same animal.
Observation period:
1 hour after the 4 hour test substance exposure.
Number of animals:
Only one animal was required (as corrosive effects were observed)
Details on study design:
TEST SITE
- Area of exposure: Back of the rabbit
- % coverage: the test substance was applied on a 2.5 x 2.5 cm lint patch
- Type of wrap if used: Lint patch lined with linseed oil paper and moisturised with 0.5 mL of water. The patch was covered with tape and fixed.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The application areas were wiped with absorbent cotton wet with water.
- Time after start of exposure: 3 minutes, 1 hour and 4 hours.

OBSERVATION TIME POINTS
(indicate if minutes, hours or days). 3 minutes, 1 hour and 4 hours of exposure (followed by 1 hour after each exposure period)

SCORING SYSTEM:
- Method of calculation: Draize criteria (1959).

METHOD:
- On the day of application, the back was separated into right and left along with the midline (head to tail) to prepare four areas for the substance to be applied. The following steps then occured:
- Application to the area exposed for three minutes. The test substance of 0.5 g was placed on a lint patch. The lint patch was applied to the application area as above. The lint patch on the application area was removed three minutes after application, the application area was wiped with absorbent cotton wet with water for injection and then the animal was returned into the cage.

- Application to the area exposed for an hour. As no corrosion changes were observed one hour after the removal of the test substance in the first step, the test substance was applied on another test area by the same procedures. The lint patch on the applied area was removed an hour after the application, the applied area was wiped by the same procedures in the first step and then the animal was returned into the cage.

- Application to the area exposed for four hours. As no corrosion changes were observed one hour after the removal of the test substance in the second step, the test substance was applied on another test area by the same procedures. A lint patch (2.5 × 2.5 cm) only, which was lined with oil paper at the same time, was applied on another application area to act as the control. The lint patch on the application site was removed four hours after application and the animal was returned to the cage. The wiping of the application area were performed by the same procedures in the earlier steps.

- Clinical signs were observed in the animal immediately after application and an hour after removal in each step. After the experiment was completed, the animal was euthanised.




Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 4 hour exposure, 1 hour observation
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Scoring time for corrosion studies not 24/48/72 hours in isolation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 4 hour exposure, 1 hour observation
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: Scoring time for corrosion studies not 24/48/72 hours in isolation
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Remarks:
Not relevant as test substance corrosion observed after 4 hours
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Remarks:
Not relevant as test substance corrosion observed after 4 hours
Irritant / corrosive response data:
After 3 minutes of exposure no erythema or oedema was observed in the area exposed to the test substance at the time point of an hour after removal of application. No corrosive change was also observed.
Grade 1 erythema and grade 3 oedema were observed in the area exposed to the test substance for an hour, at the time of an hour after removal of application. No corrosive change was observed.
Grade 4 severe erythema (injuries in depth) and grade 4 severe oedema were observed at the time of an hour after removal of the test substance for the 4 hour exposure. Brown necrosis and occurrence of changes considered to be irreversible tissue damages were observed and therefore it was judged to be corrosive.

No further animals were tested as the substance showed conclusive corrosive effects leading to classification. There was also no skin reaction in the control area.
Other effects:
No other effects or signs of systemic toxicity were noted.
Interpretation of results:
Category 1C (corrosive) based on GHS criteria
Conclusions:
The test substance was deemed to be corrosive in an in vivo dermal irritation study with sub-categorisation in accordance with UN GHS and the CLP Regulation (EC No.1272/2008) possible.
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Name:
1,4-Naphthoquinone
Implementation:
EU
Type of classification:
self-classification
Related composition:
1,4-naphthoquinone
1,4-naphthoquinone
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 conclusive but not sufficient for classification
Reason for no classification:
data conclusive but not sufficient for classification
Hazard category:
Acute Tox. 3
Hazard statement:
H301: Toxic if swallowed.
Reason for no classification:
data lacking
Hazard category:
Acute Tox. 1
Hazard statement:
H330: Fatal if inhaled.
Hazard category:
Skin Corr. 1C
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
Hazard category:
Skin Sens. 1
Hazard statement:
H317: May cause an allergic skin reaction.
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 conclusive but not sufficient for classification
Hazard category:
STOT Single Exp. 3
Hazard statement:
H335: May cause respiratory irritation.
Affected organs:
other: respiratory system
Reason for no classification:
data conclusive but not sufficient for classification
Hazard category:
Aquatic Acute 1
Hazard statement:
H400: Very toxic to aquatic life.
Hazard category:
Aquatic Chronic 1
Hazard statement:
H410: Very toxic to aquatic life with long lasting effects.
M-Factor acute:
10
M-Factor chronic:
1
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:
H318: Causes serious eye damage.
Hazard statement:
H301: Toxic if swallowed.
Hazard statement:
H330: Fatal if inhaled.
Hazard statement:
H317: May cause an allergic skin reaction.
Hazard statement:
H335: May cause respiratory irritation.
Hazard statement:
H314: Causes severe skin burns and eye damage.
Hazard statement:
H410: Very toxic to aquatic life with long lasting effects.
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:
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:
P333+P313: If skin irritation or rash occurs: Get medical advice/attention.
Precautionary statement:
P363: Wash contaminated clothing before reuse.
Precautionary statement:
P391: Collect spillage.
Precautionary statement:
P405: Store locked up.
Precautionary statement:
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
Precautionary statement:
P501: Dispose of contents/container to ...

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion