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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979-01-22
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: Federal Register 38, No. 187, Para. 1500.42, P.27029 from 27.09.1973
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
3-chloro-4-fluoroaniline
EC Number:
206-682-8
EC Name:
3-chloro-4-fluoroaniline
Cas Number:
367-21-5
Molecular formula:
C6H5ClFN
IUPAC Name:
3-chloro-4-fluoroaniline

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: M: 3220 g F: 2950 g
- Diet: SSNIFF der Firma Intermast

Test system

Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 81 mg
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3 (2 male, 1 female)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal #1
Remarks:
male
Time point:
other: 24, 72 hours
Score:
1.5
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: no information on 48h available
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
male
Time point:
other: 24, 72 hours
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: no information on 48h available
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Remarks:
male
Time point:
other: 24, 72 hours
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: no information on 48h available
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
other: 24,48, 72 hours
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
male
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritant / corrosive response data:
For animal no. 1 the scores at 48 hours could not be evaluated.
The mean cornea score opacity was >= 1 at all animals.
The mean iris score was 1 at 2 animals.
The mean conjunctivae score redness was 2 at all animals.
The mean chemosis score was 2 at 2 animals.

Following symptoms after 8 days were observed:
Animal no.1: Norrowed pupil, intergrown vessels, scar
Animal no.2: Scar
Animal no.3: Scar

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information