Registration Dossier

Administrative data

Description of key information

3-hydroxy-2-(3-hydroxy-2-quinolyl)-1H-inden-1-one is not irritating to the skin or eye.

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study under GLP conditions
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: adult
- Weight at study initiation: females 2.8-3.5 kg
- Housing: individually
- Diet ad libitum
- Water ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 /12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: the opposite side of the flank served as control
Amount / concentration applied:
500 mg moistened with water
Duration of treatment / exposure:
4 h
Observation period:
planed up to 14 days but terminated after 7 d because up to then no effects were observed
Number of animals:
3
Details on study design:
Approximately 24 hours before the test, the fur was removed by shaving from the dorsal area of the trunk of the animal . Only animals with health intact skin were used. A dose of 500 mg was applied to the test site moistened sufficiently with water to ensure good contact with the skin. The test site was then covered with a gauze patch. The patch was held in contact with the skin by means of semi-occlusive dressing for the duration of the exposure period. The opposite untreated skin served as a control. Exposure time was 4 hours. After termination the exposure period the coverage was removed and . the skin sites were evaluated for erythema and edema. Scores according to Draize were taken 24. 48, and 72 hours after patch removal for erythema and edema formation
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Remarks on result:
other: no effects were observed
Irritant / corrosive response data:
no effects wee observed
Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

According to OECD TG 404 and GLP 3 female Himalayan rabbits received dermal application on the shaved back for 4 hours held in place by semi-occlusive dressing, 60 min, 24, 28, and 72 hiours after removal of the dressing the treated area was examined and the effects scored according to Draize. None of the animals showed erythema or edema. Therefore theMacrolex Gelb G was evaluated to be non-irritating to the skin of rabbits.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Buideline study under GLP condition
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: adult
- Weight at study initiation: females 3.2-3.6 kg
- Housing: individually
- Diet ad libitum
- Water ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 /12
Vehicle:
unchanged (no vehicle)
Controls:
other: the opposite eye served as control
Amount / concentration applied:
100 µl equivalent to approd >30 mg
Duration of treatment / exposure:
24 h
Observation period (in vivo):
planned for 21 days but terminated after 7 days because no effects were observed
Number of animals or in vitro replicates:
3 females
Details on study design:
A dose ofapprox >30 mg Macrolex Gelb G was administered into th conjunctival sac of the right eye of each of 3 female rabbits after gently pulling the lower lid away fron the eyeball. The lids were then gently held together for about one second in order to prevent losss of test material.The left eye which remains untreated served as a control. 24 hours later the eyes were rinsed with saline. The eyes were examined ophthalmoscopically 24, 48 and 72 hours after administration. Eyes were evaluated for cornea opacity, iris and conjunctival changes. Scoring was done according to Draize.
24 hours after administration the eyes were treated additionally with fluorescein and examined
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
4
Remarks on result:
other: no effects were observed
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
2
Remarks on result:
other: no effects were observed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
3
Remarks on result:
other: no effects were observed
Irritant / corrosive response data:
no irritational effects were observed
Executive summary:

According to OECD 405 and GLP each of 3 female rabbits received instillations of about 30 mg test substance into the conjunctival sac of the right eye; the respective left eye remained untreated and served as control. The eyes of the animals were observed 1, 24, 48 and 72 hours post application. Additionally, 24 hours post application the eyes were treated wutg fluorescein and examined . The scoring was done according to Draize. In none of the animals eyes were affected by treatment. Therefore Macrolex Gelb G was evaluated to be non-irritating to the eyes of rabbits.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation was investigated in 3 studies. In the more recent studies, including the most recent study conducted according to guideline and GLP no skin irritation was observed. In an earler study scoring was affected due the color of the compound and limited time points investigated (24, 72 h and 8 days). All effects were reversible at the 8 days time point.

Eye irritation was investigated in 3 studies. In all studies 3-hydroxy-2-(3-hydroxy-2-quinolyl)-1H-inden-1-one is considered to be not irritating to the eyes.

Justification for classification or non-classification

3-hydroxy-2-(3-hydroxy-2-quinolyl)-1H-inden-1-one is not irritating to the skin or eye.