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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
Cited as Directive 84/449/EEC, B.5
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,4-dichloroaniline
EC Number:
209-057-8
EC Name:
2,4-dichloroaniline
Cas Number:
554-00-7
Molecular formula:
C6H5Cl2N
IUPAC Name:
2,4-dichloroaniline
Test material form:
other: brown-red flakes
Details on test material:
- Name of test material (as cited in study report): 2,4-dichloroaniline
- Physical state: solid (brown-red flakes)
- Analytical purity: 99%
-Composition: 0.1 % hydrazine hydrate

- Impurities (identity): 2,6-dichloroaniline, monochloroaniline (p-chloroaniline)
- Storage condition of test material: in the dark at 22°C

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.3 - 3.2 kg
- Housing: individually
- Diet ad libitum:
- Water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 50
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 /12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1, 24, 48, and 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
3 rabbits with intact corneas received 100 mg 2,4-dichloroaniline into the conjunctival sac of the left eye of each of the 3 rabbits. The respective right eye served as control. The reaction of the eyes were observed at 1, 24, 48, 72 hours and 7 and 14 days after application. The eyes were rinsed at first 24 hours post application and thereafter at any observation timepoint. Conjunctiva, cornea and iris were evaluated and scored according to Draize.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
not fully reversible within: within 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
other: overall cornea score
Basis:
mean
Time point:
other: up to 72 hours
Score:
0.7
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
other: overall conjunctiva score
Basis:
mean
Time point:
other: up to72 hours
Score:
1.6
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
other: overall chemosis score
Basis:
mean
Time point:
other: up to 72 hours
Score:
1.2
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 3 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 3 days
Irritation parameter:
other: overall iris score
Basis:
mean
Time point:
other: up to 72 hours
Score:
0.6
Max. score:
2
Reversibility:
fully reversible
Irritant / corrosive response data:
Based on the available effects on the eyes of all 3 rabbits which were all not fully reversible within the observation period, 2,4-dichloroaniline has to be evaluated as irritant to the eyes.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Executive summary:

2,4 -Dichloroaniline was tested for eye irritation potential according to OECD TG 405 under GLP conditions: 3 rabbits with intact corneas received 100 mg 2,4-dichloroaniline into the conjunctival sac of the left eye of each of the 3 rabbits. The respective right eye served as control. The reaction of the eyes were obsorved at 1, 24, 48, 72 hours and 7 and 14 days after application. The eyes were rinsed at first 24 hours post application and thereafter at any observation timepoint. Conjunctiva, cornea and iris were evaluated and scored according to Draize. Up to 72 hours mean scores for cornea (0.7 of max 4), conjunctiva (1.6 of max 3), chemosis (1.2 of max 4), and iris (0.6 of max 2) were noted, but these effects had not fully disappeared at the end of the observation period.


Thus, 2,4 -dichloroaniline due to the irreverible effects of the eye has to be evaluated as irritating to the eyes of rabbits.