Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: wellperformed OECD study with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity: 98.2 %

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Age at study initiation: approximately 3 - 5 months
- Weight at study initiation: about 2.7 - 3.3 kg
- Housing: in completely air conditioned rooms in single cages
- Diet: Altromin 2123 (ad libitum), 15 g hay per day
- Water: deionized and dechlorinated water from automatic suspensors ( ad libitum):

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+- 3
- Humidity (%): 50+-20
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated right eye was taken as control
Amount / concentration applied:
100 mg into the left conjunctivae sac
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: with saline
- Time after start of exposure: 24 hours

SCORING SYSTEM:
cornea: 0 - 4; iris: 0 - 2; conjunctivae: 0 - 3; chemosis: 0 - 4

TOOL USED TO ASSESS SCORE:UV lamp / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 day
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 2 d
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 0.9 hours
Score:
0.66
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 3 d
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 0.9 hours
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 3 d
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 0.9 hours
Score:
1.66
Max. score:
4
Reversibility:
not fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 3 d
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is slightly irritating to the eyes but not subject for classification
Executive summary:

The substance was tested for eye irritation according to OECD guideline 405. 3 male New zealind White rabbits were administered 100 mg of the substance into the left conjunctivae sac. After 24 hours the eyes were washed. After 1 to 24 hours after application the conjunctivae showed an intensive red colour. The iris was also red. All clinical signs had disappeared after 72 hours.

Therefore, the substance has to be classified as slightly irritant but is not subject for classification