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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1968
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
- The test performance was similar to OECD guideline, however with few deviations (Observation period of 6 days, 0.05 ml test substance applied isntead of 0.1 ml, no rinsing, no reading at time point 4 h) that did not affect the validity of the results for assessment. - The study is scientifically acceptable.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1968
Report Date:
1968

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
, observation period of 6 days, 0.05 ml test substance applied instead of 0.1 ml, no rinsing, no reading at time point 4h.
GLP compliance:
no
Remarks:
; GLP was not compulsory at the time the study was conducted

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Butandiolformal (1,3-Dioxacycloheptane)
Purity 99.99%
Physical state: liquid

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
- Age at study initiation: no data
- Weight at study initiation:
Animal 1: 2.10 kg
Animal 2: 2.37 kg
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye was treated with physiological saline and served for control
Amount / concentration applied:
0.05 ml test substance in the right eye;
0.05 ml physiological saline in ther left eye for control.
Duration of treatment / exposure:
Following application, the eyes were not washed. Examination and scoring were performed at the following time points: 10 min, 1, 3, 24, 48, 72 hours, and 6 days.
Observation period (in vivo):
6 days
Number of animals or in vitro replicates:
2
Details on study design:
Eye irritation was tested using an internal method (BASF test). 0.05 ml of the test substance were applied to the conjunctival sac of one eye of each of 2 animals. The adjacent eye which was treated with physiological saline served as control. The effects of the test substance were scored at the following time intervals: 10 min, 1h, 3h, 24h, 48h, 72h, and 6 days. At the end of the observation period, the eyes were fluorescein-stained for detection of corneal damages.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24-48-72h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible within: 6 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24-48-72h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 6 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24-48-72h
Score:
1.66
Max. score:
3
Reversibility:
fully reversible within: 6 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24-48-72h
Score:
1.66
Max. score:
2
Reversibility:
fully reversible within: 6 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24-48-72h
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 6 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24-48-72h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible within: 6 days
Irritant / corrosive response data:
ANIMAL 1:
- After 10 minutes: slight redness of the conjunctivae, slight chemosis, slight corneal opacity;
- After 1 hour: distinct redness of the conjunctivae, distinct chemosis, slight corneal opacity;
- After 24 hours: distinct redness of the conjunctivae, slight chemosis, milky corneal opacity; mucosal bleeding and milky secretion;
- After 48 hours: slight redness of the conjunctivae, slight chemosis, slight corneal opacity; suppurative secretion;
- After 72 hours: slight redness of the conjunctivae, slight chemosis, slight corneal opacity; suppurative secretion, mucosal bleeding; scar on the upper eyelid;
- After 6 days: no more findings, fluorescein-staining revealed no corneal lesions.
ANIMAL 2:
- After 10 minutes: slight redness of the conjunctivae, slight chemosis, slight corneal opacity;
- After 1 hour: distinct redness of the conjunctivae, distinct chemosis, slight corneal opacity;
- After 24 hours: distinct redness of the conjunctivae, slight chemosis, slightly milky to milky corneal opacity; mucosal bleeding;
- After 48 hours: distinct redness of the conjunctivae, slight chemosis, slight corneal opacity; mucosal bleeding;
- After 72 hours: slight redness of the conjunctivae, no more chemosis, slight corneal opacity; mucosal bleeding;
- After 6 days: no more findings, fluorescein-staining revealed no corneal lesions.

Applicant's summary and conclusion