Reaction mass of 6-(butan-2-yl)quinolone and 8-(butan-2-yl)quinoline

Eye irritation

Administrative data

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.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 6-(butan-2-yl)quinolone and 8-(butan-2-yl)quinoline

EC Number:

916-241-8

Molecular formula:

C13H15N

IUPAC Name:

Reaction mass of 6-(butan-2-yl)quinolone and 8-(butan-2-yl)quinoline

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Isobutylquinoleine
- Physical state: liquid

Test animals / tissue source

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

Test system

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).

Results and discussion

In vivo

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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

Results 5

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

Results 6

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

Results 7

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"

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

Applicant's summary and conclusion

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.