Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Three animals were applied 100 µg of the test substance into the conjunctival sac of one eye. The other eye served as control. The treated eye was washed after 24 hours with physiologic saline. After 1, 24, 48, 72 hours and 7 days the eyes were scored for cornea, iris, conjunctivae and chemosis according to Draize.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
1-hydroxy-4-(p-toluidino)anthraquinone
EC Number:
201-353-5
EC Name:
1-hydroxy-4-(p-toluidino)anthraquinone
Cas Number:
81-48-1
Molecular formula:
C21H15NO3
IUPAC Name:
1-hydroxy-4-[(4-methylphenyl)amino]-9,10-anthraquinone

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Three male rabbits with an average weight of 3.5 kg were used. The animals were housed in single cages at a room temperature of 19 - 25° C and a relative humidity of 40 - 60 %. The dark/light cycle was 12 hours. The animals received a standard nutrition and tap water ad libitum.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
100 µl
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 animals
Details on study design:
Three animals were applied 100 µg of the test substance into the conjunctival sac of one eye. The other eye served as control. The treated eye was washed after 24 hours with physiologic saline. After 1, 24, 48, 72 hours and 7 days the eyes were scored for cornea, iris, conjunctivae and chemosis according to Draize.

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:
4
Reversibility:
other: score = 0 at any time point
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: score = 0 at any time point
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: score = 0 at any time point
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritant / corrosive response data:
Cornea opacity, iris, conjunctivae and chemosis scores were 0 at any time point (24, 48 and 72 hours).
Other effects:
No data

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Cornea opacity, iris, conjunctivae and chemosis scores were 0 at any time point (24, 48 and 72 hours).
Executive summary:

Three animals were applied 100 µg of the test substance into the conjunctival sac of one eye. The other eye served as control. The treated eye was washed after 24 hours with physiologic saline. After 1, 24, 48, 72 hours and 7 days the eyes were scored for cornea, iris, conjunctivae and chemosis according to Draize. Cornea opacity, iris, conjunctivae and chemosis scores were 0 at any time point (24, 48 and 72 hours). 1-hydroxy-4-(p-toluidino)anthraquinone is not irritating to the eyes: