2,6-xylidine

Eye irritation

Administrative data

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:

guideline study

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:

12 May 1981

Deviations:

yes

Remarks:

observation period (8 d)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,6-xylidine

EC Number:

201-758-7

EC Name:

2,6-xylidine

Cas Number:

87-62-7

Molecular formula:

C8H11N

IUPAC Name:

2,6-dimethylaniline

Test material form:

liquid

Specific details on test material used for the study:

- Name of test material (as cited in study report): 2,6-Dimethylanilin

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Gaukler, Offenbach/Main, D
- Mean weight at study initiation: male 3.03 kg; females 2.92 kg
- Housing: individually
- Diet (ca. 130g/ animal*d): Ovator Solikanin, Musaktor-Werke, Duesseldorf, D
- Water (ca. 250 mL/animal*d): tap water
- Acclimation period: ca. 8 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

unspecified

Observation period (in vivo):

8 d

Number of animals or in vitro replicates:

3 (one male, two females)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no removal


SCORING SYSTEM: OECD Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24-48-72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 d

Remarks on result:

other: see table for details

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24-48-72 h

Score:

0.44

Max. score:

2

Reversibility:

fully reversible within: 8 d

Remarks on result:

other: see table for details

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24-48-72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 8 d

Remarks on result:

other: see table for details

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24-48-72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 d

Remarks on result:

other: see table for details

Any other information on results incl. tables

Exposition:	unspecified
Animal	Reading	Opacity	Cornea area	Iritis	Redness	Chemosis	Discharge	Symptoms
1	1 h	0	0	1	3	2	3	pupil constricted
2	1 h	0	0	1	3	2	3	pupil constricted
3	1 h	0	0	1	3	2	3	pupil constricted
1	24 h	1	4	0	2	1	0
2	24 h	1	4	0	2	1	2	purulence
3	24 h	1	3	1	2	1	1
1	48 h	1	4	0	2	1	0
2	48 h	1	4	0	2	1	2	purulence
3	48 h	1	3	1	2	1	1
1	72 h	1	4	1	2	1	1	pupil constricted
2	72 h	1	3	0	2	1	1	pupil constricted/purulence/ scar on the eyelid
3	72 h	1	2	1	2	1	1	pupil constricted/ scar on the eyelid
1	8 d	0	0	0	1	0	0
2	8 d	0	0	0	1	0	0	scar on the eyelid
3	8 d	0	0	0	0	0	0	scar on the eyelid
mean animal 1	24 - 72 h	1.00		0.33	2.00	1.00
mean animal 2	24 - 72 h	1.00		0.00	2.00	1.00
mean animal 3	24 - 72 h	1.00		1.00	2.00	1.00
overall mean	24 - 72 h	1.00		0.44	2.00	1.00

Applicant's summary and conclusion

Interpretation of results:

Category 2A (irritating to eyes) based on GHS criteria

Conclusions:

Based on the effect of the temporarily constricted eyelids as sign for iritis and the moderate conjunctivae redness, 2,6 -xylidine has to be considered as eye irritant Cat. 2A according to GHS requirements).

Executive summary:

The study was performed according to OECD 405. Three rabbits were exposed to 0.1 mL test substance; eyes were not washed out. The animals were observed for 8 d.

Slight corneal opacity, iritis and chemosis were completely reversible within 8 d. Moderate conjunctivae redness was not fully reversible in 2/3 animals within 8 d. However, a clear trend over time for decreasing effect strength was observable, and in 1/3 animals the redness was completely reversible. As additional effect, contracted pupils as reversible effect in all animals (a sign for iritis) and scars on the eyelid in 2/3 animals at the end of the observation period were observed. Since a observation period of 21 d was not exhausted as recommended in the actual guideline, the complete reversibility of the relevant conjunctivae redness can only be assumed.

Conclusion: Based on the effect of the temporarily constricted eyelids as sign for iritis and the moderate conjunctivae redness, 2,6 -xylidine has to be considered as eye irritant Cat. 2 according to GHS requirements).