2,4-xylidine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986-02-11 to 1986-02-27

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline conform GLP study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Remarks:

GLP declaration attached to full study report

Test material

Test material information

Constituent 1

Reference substance name:

2,4-xylidine

EC Number:

202-440-0

EC Name:

2,4-xylidine

Cas Number:

95-68-1

Molecular formula:

C8H11N

IUPAC Name:

2,4-dimethylaniline

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Source: Hoechst AG, Kastengrund, conventional breeding
Number of animals: 3
Identification: numbered ear labels
Weight: 2.2 - 2.4 kg
Age: 3 to 5 months
Housing: air conditioned rooms, single cages
Temperature: 20 +/- 3°C
Relative humidity: 50 +/- 20 %
Lighting conditions: 12 hrs daily
Diet: Altromin 2123 - rabbit, ad libitum as well as hay (15 g daily)
Water: deionised, chlorinated water from automatic dispensers, ad libitum

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: Untreated eye of each animal serves as control

Amount / concentration applied:

0.1 ml of test substance

Duration of treatment / exposure:

24 hrs

Observation period (in vivo):

Total of 7 days observation period

Number of animals or in vitro replicates:

3

Details on study design:

- 24 hrs before start of study eyes where checked for damage (with Fluorescine solution 0.01 % and ultraviolet light).

- 24 after exposure as well as at each following observation where discharge was observed or a check for eye damage was performed, eyes where washed with physiol. saline solution (37 °C).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: Mean of 24, 48 and 72 hrs

Score:

0

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: Mean of 24, 48 and 72 hrs

Score:

1.7

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: Mean of 24, 48 and 72 hrs

Score:

1.7

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: Mean of 24, 48 and 72 hrs

Score:

1.1

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: Mean of 24, 48 and 72 hrs

Score:

1

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: Mean of 24, 48 and 72 hrs

Score:

1

Reversibility:

fully reversible within: 7 days

Results 7

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: Mean of 24, 48 and 72 hrs

Score:

1.7

Reversibility:

fully reversible within: 7 days

Results 8

Irritation parameter:

iris score

Basis:

mean

Time point:

other: Mean of 24, 48 and 72 hrs

Score:

1.2

Reversibility:

fully reversible within: 7 days

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: Mean of 24, 48 and 72 hrs

Score:

1

Reversibility:

fully reversible within: 7 days

Results 10

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: Mean of 24, 48 and 72 hrs

Score:

1.7

Reversibility:

fully reversible within: 7 days

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: Mean of 24, 48 and 72 hrs

Score:

2

Reversibility:

fully reversible within: 7 days

Results 12

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: Mean of 24, 48 and 72 hrs

Score:

1.6

Reversibility:

fully reversible within: 7 days

Results 13

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: Mean of 24, 48 and 72 hrs

Score:

0

Reversibility:

fully reversible within: 7 days

Results 14

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: Mean of 24, 48 and 72 hrs

Score:

1.3

Reversibility:

fully reversible within: 7 days

Results 15

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: Mean of 24, 48 and 72 hrs

Score:

2.7

Reversibility:

fully reversible within: 7 days

Results 16

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: Mean of 24, 48 and 72 hrs

Score:

1.3

Reversibility:

fully reversible within: 7 days

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the present study m-Xyldine asym. is irritant to the eye according to the provisions laid down in 83/467/EEC and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
Labelling is Xi (irritant) with R36 - irritating to the eyes / H319 - Causes serious eye irritation.

Executive summary:

Based on the present study m-Xyldine asym. is irritant to the eye according to the provisions laid down in 83/467/EEC and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

Labelling is Xi (irritant) with R36 - irritating to the eyes / Cat. 2, H319 - Causes serious eye irritation.