Registration Dossier

Diss Factsheets

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:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2-difluoro-benzo[1,3]dioxole-4-carbaldehyde
EC Number:
700-476-6
Cas Number:
119895-68-0
Molecular formula:
C8H4F2O3
IUPAC Name:
2,2-difluoro-benzo[1,3]dioxole-4-carbaldehyde

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2490 - 2690 g
- Housing: individually in metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1992-06-16 To: 1992-07-17

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal served as control
Amount / concentration applied:
0.1 mL undiluted test material
Duration of treatment / exposure:
Single exposure, no washing
Observation period (in vivo):
10 days
Number of animals or in vitro replicates:
3 (experiment started with 1 animal, due to slight reactions 2 further animals were added)
Details on study design:
TOOL USED TO ASSESS SCORE: hand-slit lamp

SCORING SYSTEM: OECD scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.78
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
In two out of three animals reactions were observed 72 hours after instillation of the test material. Therefore observation period for these animals was extended to 10 days to determine the reversibility of the eye reactions. The eye reactions were reversible until the end of observation period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU GHS
Conclusions:
Under the conditions of this eye irritation study in the rabbit the test material was not irritating to the eye.