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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:
1968-10-02 to 1968-10-16
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study predating guidelines and GLP, but obtained by standardised procedures comparable to those presently in use and thus valid for characterising the toxicity of the substance tested.

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
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not applicable
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-methylbutan-2-ol
EC Number:
200-908-9
EC Name:
2-methylbutan-2-ol
Cas Number:
75-85-4
Molecular formula:
C5H12O
IUPAC Name:
2-methylbutan-2-ol

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation:
Animal 1: male, 2.45 kg
Animal 2: female, 2.37 kg
Animal 3: male, 2.5 kg
Animal 4: male, 2.33 kg

ENVIRONMENTAL CONDITIONS
- no data

IN-LIFE DATES: From: 1968-10-02 To: 1968-11-16

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: control eye: left eye of same animal
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.05 mL of undiluted test item (corresponds to about 40.3 mg test item)

CONTROL MATERIAL
- Amount applied: 0.05 mL of "NaCl" (probably physiol. saline solution)
Duration of treatment / exposure:
not applicable - eye not rinsed after 24 hours
Observation period (in vivo):
8 days (readings at 1h, 24h and 8d after application)
Number of animals or in vitro replicates:
three male, one female
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: Draize score (converted from recorded grading with detailed instructions provided by data owner)

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48 and 120h (mean)
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 7 days (euthanised due to devel. staphylom)
Remarks on result:
other: No 72h and 96h readout in raw data
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48 and 120h (mean)
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: No 72h and 96h readout in raw data
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48 and 72h (mean)
Score:
2.33
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: 24, 48 and 72h (mean)
Score:
2.67
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48 and 120h (mean)
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: No 72h and 96h readout in raw data
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48 and 120h (mean)
Score:
2.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: No 72h and 96h readout in raw data
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48 and 72h (mean)
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
other: 24, 48 and 72h (mean)
Score:
0
Max. score:
4
Remarks on result:
other: scores of 3 before and after standard readings, but fully reversible within 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48 and 120h (mean)
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 7 days (euthanised due to devel. staphylom)
Remarks on result:
other: No 72h and 96h readout in raw data
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48 and 120h (mean)
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: No 72h and 96h readout in raw data
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48 and 72h (mean)
Score:
2.33
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
other: 24, 48 and 72h (mean)
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48 and 120h (mean)
Score:
0.67
Max. score:
2
Reversibility:
not fully reversible within: 7 days (euthanised due to devel. staphylom)
Remarks on result:
other: No 72h and 96h readout in raw data
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48 and 72 h (mean)
Score:
0
Max. score:
2
Remarks on result:
other: No 72h and 96h readout in raw data
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48 and 72h (mean)
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 6 days
Irritation parameter:
iris score
Basis:
animal #4
Time point:
other: 24, 48 and 72h (mean)
Score:
0
Max. score:
2
Irritant / corrosive response data:
Instillation of undiluted test item caused slight to marked conjunctival irritation with swelling of the lids and occasional bleeding.
In one case, a staphylom developed and the rabbit was euthanised. Corneal opacity was found to be marked to severe.
A slight iritis was occasionally observed. Not all effects were reversible within the maximum observation period of 8 days.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU