Registration Dossier

Administrative data

Description of key information

Skin irritation (rabbit): not irritating

Eye irritation (rabbit): corrosive

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:
04 - 09 Aug 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
28 Jul 2015
Deviations:
yes
Remarks:
(all 3 animals were tested in parallel, no initiating and confirmatory test performed)
GLP compliance:
yes (incl. certificate)
Remarks:
Bayrisches Landesamt für Arbeitsschutz, Arbeitsmedizin und Sicherheitstechnik, München, Germany
Species:
rabbit
Strain:
New Zealand White
Remarks:
HsdIf:NZW
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Weight at study initiation: at least 2 kg bw
- Housing: housed in ABS - plastic rabbit cages, floor 4200 cm²
- Diet: Altromin 2123, ad libitum
- Water: tap water, ad libitum)
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g
Duration of treatment / exposure:
4 h
Observation period:
72 h
Reading time points: 1, 24, 48 and 72 h
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: 6 cm² on the dorsal area of the trunk
- Type of wrap if used: The test substance was applied to a gauze patch which was applied to the skin and fixed with a non-irritating, semi-occlusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing: Residual test material was removed with tap water
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
Reading time points: 1, 24, 48 and 72 h

SCORING SYSTEM:
- Method of calculation: Draize scoring system
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The test item showed neither irritant nor corrosive effects on the intact skin of 3 rabbits after a contact time of 4 h.
Other effects:
Body weight evolution appeared normal.
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
Conclusions:
CLP: not classified
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
Study period:
18 Aug - 08 Sep 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
02 Oct 2012
Deviations:
yes
Remarks:
(no systemic analgesic and topical anesthesia used)
GLP compliance:
yes (incl. certificate)
Remarks:
Bayrisches Landesamt für Arbeitsschutz, Arbeitsmedizin und Sicherheitstechnik, München, Germany
Species:
rabbit
Strain:
New Zealand White
Remarks:
HdIf:NZW
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Weight at study initiation: > 2.0 kg weight
- Housing: housed in ABS - plastic rabbit cages, floor 4200 cm²
- Diet: Altromin 2123, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 g
Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
Animal no.1: 20 days; Reading time points: 1, 24, 48 and 72 h and daily from Day 4 - Day 20
Animal no. 2 and 3: 168 h; Reading time points: 1, 24, 48 and 72 h and daily from Day 4 - Day 7
Number of animals or in vitro replicates:
3 females
Details on study design:
SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
1.2
Max. score:
3
Reversibility:
fully reversible within: 7 days in 2 animals, within 4 days in 1 animal
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0.4
Max. score:
4
Reversibility:
fully reversible within: within 3 days in 1 animal, within 2 days in 2 animals
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
not fully reversible within: 20 days in 1 animal, no effect in 2 animals
Irritant / corrosive response data:
Instillation of the test substance into the eyes of rabbits produced signs of irritation in all animals. In detail, redness and chemosis of the conjunctivae were observed in all test animals. Those effcets were fully reversible latest within 168 or 72 hours, respectively. Furthermore, 1/3 animals showed corneal opacity which was not reversible until the end of the observation period (20 days). In the 2 remaining animals, no effects on the cornea were determined. No effects on the iris were observed in any test animal.
Other effects:
Body weight evolution appeared normal.

Table 1 Results of eye irritation

Rabbit # Time [h] conjunctivae   iris cornea
redness swelling
1 1 2 2 0 1
24 1 1 0 1
48 1 0 0 1
72 1 0 0 1
average 1,0 0,3 0,0 1,0
2 1 2 2 0 0
24 2 1 0 0
48 1 0 0 0
72 1 0 0 0
average 1,3 0,3 0,0 0,0
3 1 2 2 0 0
24 2 1 0 0
48 1 1 0 0
72 1 0 0 0
average 1,3 0,7 0,0 0,0
   
Time [h] conjunctivae   iris cornea
  redness swelling    
average
score
1 2,00 2,00 0,00 0,33
24 1,67 1,00 0,00 0,33
48 1,00 0,33 0,00 0,33
72 1,00 0,00 0,00 0,33
24+48+72 1,2 0,4 0,0 0,3
Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
CLP: Cat. 1, H318
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

The skin irritancy potential of quinolin-8-ol (CAS 148-24-3) was determined in a skin irritation study in white rabbits (NZW) performed according to GLP and OECD TG 404 (reference 7.3.1-1). The test substance was topically applied to the skin of three rabbits for 4 h. Local reactions were scored at 1, 24, 48 and 72 h. No local reactions were observed (meanerythema and edema scores of 0.0 calculated as mean for all animals over 24, 48 and 72 h). Based on the results of the conducted study,quinolin-8-oldid not exhibit irritating properties towards the skin.

Eye irritation

To evaluate the irritation potential towards the eyes, 0.1 g quinolin-8-ol (CAS 148-24-3) was instilled into the eyes of three white rabbits (NZW) similar to OECD TG 405 and GLP criteria (reference 7.3.2-1). The reactions were observed 1 h after substance application and daily from Day 1 up to Day 20. Instillation of the test substance into the eyes produced signs of irritation in all animals. In detail, redness and chemosis of the conjunctivae were observed in all test animals. Those effects were fully reversible latest within 168 hours, respectively. Furthermore, 1/3 animals showed corneal opacity which was not reversible until the end of the observation period (20 days). In the 2 remaining animals, no effects on the cornea were determined. No effects on the iris were observed in any test animal. Based on the irreversible corneal lesion observed in 1/3 animals, quinolin-8-ol is considered as corrosive to the eyes.

Justification for classification or non-classification

Based on the available data on skin irritation, quinolin-8-ol does not meet the classification criteria for skin irritation according to Regulation (EC) 1272/2008. The available data on eye irritation with quinolin-8-ol (CAS 148-24-3) meet the criteria for classification as Eye Dam. Cat. 1 (H318) according to Regulation (EC) 1272/2008.