3,4-dichloroaniline

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:

other: GLP-guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,4-dichloroaniline

EC Number:

202-448-4

EC Name:

3,4-dichloroaniline

Cas Number:

95-76-1

Molecular formula:

C6H5Cl2N

IUPAC Name:

3,4-dichloroaniline

Details on test material:

- Name of test material (as cited in study report): 3,4-Dichloranilin
- Physical state: solid, crystalline
- Analytical purity: not reported
- Lot/batch No.: GEAC 40, December 1985
- Storage condition of test material: 22 °C, dark, under fume hood

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Age at study initiation: 3-5 months
- Weight at study initiation: 1.9-3.0 kg
- Housing: individually in cages, marked by ear tags
- Diet: ad libitum, Altromin 2123, 15 g hay per day
- Water: ad libitum, deionized, chlorinated

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye served as control

Amount / concentration applied:

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

Duration of treatment / exposure:

24 h

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological saline solution, 37 °C
- Time after start of exposure: 24h and after every examination with fluorescein


SCORING SYSTEM: according to OECD guideline 404

TOOL USED TO ASSESS SCORE: fluorescein 0.01 %

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: average over 24, 48 and 72 h

Score:

1.3

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: average over 24, 48 and 72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 d

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: average over 24, 48 and 72 h

Score:

0

Max. score:

0

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: average over 24, 48 and 72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: average over 24, 48 and 72 h

Score:

0.67

Max. score:

1

Reversibility:

fully reversible within: 7 d

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: average over 24, 48 and 72 h

Score:

0.67

Max. score:

1

Reversibility:

fully reversible within: 7 d

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: average over 24, 48 and 72 h

Score:

1.7

Max. score:

2

Reversibility:

fully reversible within: 7 d

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: average over 24, 48 and 72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 7 d

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: average over 24, 48 and 72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 d

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: average over 24, 48 and 72 h

Score:

0.7

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: average over 24, 48 and 72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 d

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: average over 24, 48 and 72 h

Score:

1.33

Max. score:

2

Reversibility:

fully reversible within: 7 d

Other effects:

Fluorescein test (elucidation of cornea under UV-light after fluorescein treatment of the eye):
0= no elucidation
1= punctual to 1/4 of cornea elucidated
2= more than 1/4 to 1/2 of cornea elucidated
3= more than 1/2 to 3/4 of cornea elucidated
4= more than 3/4 to all of cornea elucidated

Result:
mean score (max. score) : 1.83 (3.5)
fully recovered within 7 days

one animal showed vascularisation of the cornea after 7 days

Any other information on results incl. tables

1 h post treatment the treated corneas of the rabbits were swollen and red and clear discharge was evident.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Xi/ R41

Conclusions:

Classification: risk of serious damage to eyes

Executive summary:

Hofmann, T and Weigand, W, 1986

The testing of 3,4 -dichloroaniline for eye irritation/ corrosion on three New Zealand White rabbits according to OECD guideline 405/ EU B.5 did result in mild irritation. Nevertheless vascularisation of the cornea was observed in one animal as late as 7 days post application. Vascularisation of the cornea is to be considered a severe damage to the eye, since it leads to destruction of corneal transparency. Therefore 3,4 -dichloroaniline was classified as irritating.