Registration Dossier

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:
April 11, 1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965)
Deviations:
yes
Remarks:
no informations
Principles of method if other than guideline:
Similar to OECD guideline 405
GLP compliance:
no
Remarks:
pre GLP

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 1-amino-4-[[3-[(benzoylamino)methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
EC Number:
267-224-0
EC Name:
Sodium 1-amino-4-[[3-[(benzoylamino)methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
Cas Number:
67827-60-5
Molecular formula:
C31H26N3O6S.Na
IUPAC Name:
sodium 1-amino-4-[[3-[(benzoylamino)methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate
Test material form:
not specified

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: bred on the premises
- Age at study initiation: 9-13 weeks
- Weight at study initiation: 2.19 kg to 2.28 kg
- Housing: singly in an experimental room
- Diet: Styles-Oxoid ad libitum
- Water: Sterile filtered water available at all times
- Acclimation period: one week prior to the start of the trial

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C. ( ±1°)
- Humidity (%): 50-70 %
- Photoperiod (hrs dark / hrs light): Animals exposed to artificial light for 10 hours daily from 08.00 -18.00 hours

Test system

Vehicle:
not specified
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 100 mg
Duration of treatment / exposure:
30 sec
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
6 (3 males and 3 females)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: flushed out with warm water for 1 minute

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal: 14, 15, 16
Time point:
other: mean score following grading at 24, 48, 72 h
Score:
ca. 0
Max. score:
0
Reversibility:
other: no ocular effect observed
Remarks on result:
other: washed eyes
Irritation parameter:
iris score
Basis:
animal: 14, 15, 16
Time point:
other: mean score following grading at 24, 48, 72 h
Score:
ca. 0
Max. score:
0
Reversibility:
other: no ocular effect observed
Remarks on result:
other: washed eyes
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: 14, 15
Time point:
other: mean score following grading at 24, 48, 72 h
Score:
ca. 1
Max. score:
1
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: washed eyes
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: 16
Time point:
other: mean score following grading at 24, 48, 72 h
Score:
ca. 1.66
Max. score:
2
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: washed eyes
Irritation parameter:
chemosis score
Basis:
animal: 14, 15, 16
Time point:
other: mean score following grading at 24, 48, 72 h
Score:
ca. 0.33
Max. score:
1
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: washed eyes

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
Not irritant
Executive summary:

Method

The eye irritation was determined in an irritation test on rabbits according to the "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965), similar to OECD guideline 405.

Observation

A slight to mild conjunctival reaction was seen in all treated eyes from 1 hour after application of the compound. The washed eyes were slightly less severe and returned to normal by day 6.

Result

Not irritant.

Categories Display