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Administrative data

Description of key information

Skin irritation, OECD TG 404: Skin irritant
Eye irritation, OECDTG 405: Not eye irritating

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:
September 3, 1990 - September 17, 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Reliability 1 is assigned because the study is conducted according to OECD TG 404, in compliance with GLP, without deviations that influence the quality of the results.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(1981)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
(1984)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, CH-4414 Füllinsdorf, Switzerland
- Age at study initiation: males: 15 weeks; female: 16 weeks
- Weight at study initiation: males: 3.0-3.1 kg; female: 2.3 kg
- Housing: Animals were housed individually in stainless steel cages equipped with an automatic cleaning and drinking system
- Diet: Free access to pelleted diet for rabbits (Kliba 341, Batch 55/90, Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland)
- Water: Free access to tap water.
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: Adjacent areas of the untreated skin of each animal served as controls.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
2 males and 1 female
Details on study design:
TEST SITE
Approximately 24 hours before treatment, the dorsal fur was clipped with an electric clipper, exposing an area of approximately 100 square centimeters (10x10 cm).

TREATMENT
On day 1, 0.5 mL of the test substance was applied to approx. 6 square centimeters of the intact skin of the clipped area. It was covered with a 3 x 3 cm patch of surgical gauze. The gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage.

REMOVAL OF TEST SUBSTANCE
Four hours after the application, the dressing was removed and the skin cleaned of residual test substance using tap water.

OBSERVATIONS
- Mortality/Viability and Clinical signs: Daily
- Body Weight: At the start of acclimatization, day 1 (application day) and at termination (day 15)
- Irritation: The skin reactions were assessed at approximately 1, 24, 48 and 72 hours and at 7 and 14 days after the removal of the dressings and test substance. The irritation scores and a description of all other (local) effects were recorded.

SCORING SYSTEM:
The irritation was assessed according to the numerical scoring system according to OECD 404 (1981).
Irritation parameter:
erythema score
Basis:
animal: #1, #2 and #3
Time point:
other: 24, 48 and 72 hours (mean)
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal: #1, #2 and #3
Time point:
other: 24, 48 and 72 hours (mean)
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Animal #1: slight fissures and desiccated skin by 72 hours and scar formations by day 7; Animal #1 and #2: moderate to slight scales between day 7 to 14; Animal #3: slight scales between day 7 to 14 and desiccated skin by 72 hours
Other effects:
- No acute clinical symptoms were observed
- No mortality occurred
- No adverse effect on the body weight gain was observed
Interpretation of results:
Category 2 (irritant)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a skin irritation study with rabbits, performed according to OECD 404 (1981), irritation was observed, which was fully reversible within 14 days, although scaling was still present. Based on the results of this study, the substance is considered a skin irritant: Category 2 (H315).
Executive summary:

Sec Butyl Quinoline was tested in a skin irritation test in 3 rabbits in accordance with OECD TG 404 (1981) test guideline and according to GLP principles. The mean value for erythema from gradings at 24, 48 and 72 hours after patch removal was 3 in all animals. For oedema, this mean value was 2 in all animals. No corrosive effect was observed. The irritation was fully reversible within 14 days, although scaling was still present. Based on the results of this study, the substance is considered a skin irritant.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (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:
August 30, 1982 - September 7, 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Reliability 2 is assigned because the study is conducted according to OECD TG 405, without deviations that influence the quality of the results but predating GLP requirements.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(1981)
Deviations:
no
GLP compliance:
no
Remarks:
Study performed before GLP was introduced in Europe
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Source: Füllinsdorf Breeding Farm
- Weight at study initiation: Body weights were at least 2 kg
- Housing: Individually
Vehicle:
unchanged (no vehicle)
Controls:
other: One eye of each animal remained untreated and served as the reference control.
Amount / concentration applied:
Amount applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
Single instillation on Day 1
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
3 males/females
Details on study design:
STUDY DESIGN
The test material was first applied at 30% in the solvent Diethylphthalate, in 3 animals. As this caused only weak conjunctival irritation, the study was continued by applying the test substance undiluted in 3 additional animals.

TREATMENT
In accordance with OECD 405 (1981). The test substance is placed in the conjunctival sac of one eye of each animal after gently pulling the lower lid away from the eyeball. The lids are then gently held together for about one second. The other eye serves at control.

REMOVAL OF TEST SUBSTANCE
-Washing: No

OBSERVATIONS
- Irritation:
The eyes of each animal were examined approximately 1, 24, 48 and 72 hours and 7 and 14 days after instillation of the test substance.
The irritation scores and a description of all other (local) effects were recorded. The irritation was assessed according to OECD 405 (1981).
Irritation parameter:
cornea opacity score
Remarks:
(opacity)
Basis:
animal: #1 and #2 (mean)
Time point:
other: 24, 48 and 72 hrs
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Remarks:
(opacity)
Basis:
animal: #3 (mean)
Time point:
other: 24, 48 and 72 hrs
Score:
> 0 - < 0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Corneal opacity was observed, only at 24 hours, but not enough for assigning a score of 1
Irritation parameter:
iris score
Basis:
animal: #1, #2 and #3 (mean)
Time point:
other: 24, 48 and 72 hrs
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean)
Time point:
other: 24, 48 and 72 hrs
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean)
Time point:
other: 24, 48 and 72 hrs
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean)
Time point:
other: 24, 48 and 72 hrs
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal: #1, #2 and #3 (mean)
Time point:
other: 24, 48 and 72 hrs
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
See section "Any other information on results incl. tables"

Irritant response data (for the undiluted test substance)

 

Time after administration

 

1 hour

24 hours

48 hours

72 hours

Animal:

1

2

3

1

2

3

1

2

3

1

2

3

Cornea score (opacity)

0

0

0

0

0

+

0

0

0

0

0

0

Iris score

1

1

1

1

1

1

0

0

0

0

0

0

Conjunctivae score (redness)

2

2

2

2

2

3

1

2

1

0

1

0

Chemosis score

1

1

1

1

1

1

0

0

0

0

0

0
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an eye irritation study with rabbits, performed according to OECD 405 (1981), limited irritation was observed. Based on the results of this study, the substance does not need to be classified for eye irritation, in accordance with the CLP Regulation.
Executive summary:

Sec Butyl Quinoline was tested in an eye irritation test in rabbits according to OECD 405 (1981). Slight ocular effects were observed, which were fully reversible within 7 days. The cornea and iris scores were < 0.33. The conjunctival redness and conjunctival oedema following grading at 24, 48 and 72 hours after installation of the substance were 2 or lower, exept one animal, which scored 3 at the 24 h only. Therefore the substance is not considered an eye irritant.

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

Additional information

Skin irritation: Sec Butyl Quinoline was tested in a skin irritation test in 3 rabbits in accordance with OECD TG 404 (1981) test guideline and according to GLP principles. The mean value for erythema from gradings at 24, 48 and 72 hours after patch removal was 3 in all animals. For oedema, this mean value was 2 in all animals. No corrosive effect was observed. The irritation was fully reversible within 14 days, although scaling was still present. Based on the results of this study, the substance is considered a skin irritant.

Eye irritation: Sec Butyl Quinoline was tested in an eye irritation test in rabbits according to OECD 405 (1981). Slight ocular effects were observed, which were fully reversible within 7 days. The cornea and iris scores were <0.33. The conjunctival redness and conjunctival oedema following grading at 24, 48 and 72 hours after installation of the substance were 2 or lower, except one animal, which scored 3 at the 24 h observation time only. Therefore the substance is not considered an eye irritant.


Justification for selection of skin irritation / corrosion endpoint:
The result of the study is reliable and adequate for covering the endpoint

Justification for selection of eye irritation endpoint:
The result of the study is reliable and adequate for covering the endpoint.

Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

Based on the results of the studies, Sec Butyl Quinoline need to be classified for skin irritation and not for eye irritation resulting in irritating to skin, category 2 (H315), in accordance with Regulation (EC) No. 1272/2008 or R38 in accordance with Directive 67/548/EEC.