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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
no observation on day 21 after start was done; observations were done up to 72 h after start.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Principles of method if other than guideline:
3 rabbits; rinsed eye; 3-day observation for signs on conjunctiva, cornea and iris.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Direct Red 111
IUPAC Name:
Direct Red 111

Test animals / tissue source

Species:
rabbit

Test system

Vehicle:
not specified
Observation period (in vivo):
Up to 72 h.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: not specified

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
1
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal: #1, #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation

Any other information on results incl. tables

animal finding 24 h 48 h 72 h
1 conj. chemosis 1 0 0
conj. redness 1 0 1
corneal opacity 0 0 0

iritis

 0 0 0
2

conj. chemosis

 0 0 0
conj. redness 1 0 1
corneal opacity 0 0 0

iritis

 0 0 0
3 conj. chemosis 1 0 0
conj. redness 2 1 1
corneal opacity 0 0 0
iritis 0 0 0

Applicant's summary and conclusion

Interpretation of results:
other: not irritant according to the CLP Regulation (EC 1272/2008)
Conclusions:
Not irritant to the rabbit eye.
Executive summary:

Method

Test substance was applied to the eye of 3 rabbits; treated eye were rinsed. Effects on conjunctivae, cornea and iris were scored 24, 48 and 72 h after start.

Results

No signs of irritation were noted on cornea and iris; conjunctivae chemosis was noted in 2/3 rabbits at 24 h and it was completely reversible within 48 h. Conjunctivae redness was noted in all rabbits; it was not fully reversible within the 72 h observation period, however such signs were slight, i.e. score 1 after 72 h.