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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:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report which meets basic scientific principles; pre-GLP study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report Date:
1969

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
reading after 1,24hours, 8 days, 2 animals
Principles of method if other than guideline:
BASF-Test
GLP compliance:
no
Remarks:
pre-GLP study

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2,3,6-trimethyl-phenol (TMP)
No further data

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
dark/light rhythm 12/12 hours

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: talcum
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 spoon of the kristalline unchanged substance
Duration of treatment / exposure:
up to 8 days, no substance wash out
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM:
BASF scores, convertible into Draize scores, readings at 24 hours and 8 days after beginning of application

TOOL USED TO ASSESS SCORE: no data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 0-8 days
Score:
>= 1 - <= 3
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: staphyloma
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 0-8 days
Score:
>= 0 - <= 1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 0-8 days
Score:
>= 1 - <= 2
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: staphyloma
Irritant / corrosive response data:
see table

Any other information on results incl. tables

Draize scores and findings:

Reading

Animal no

Treated eye

Control eye

Cornea

Iris

Redness

Edema

Remarks

Redness

Remarks

1 hour

1

1

0

1

3-4

-

2

RS

2

1

0

1

2

-

2

RS

24 hours

1

3

1

2

2

H

2

2

3

1

2

2

-

0

8 days

1

3

0

2

0

S, IV

0

2

3

0

0

0

IV

0

Legend: abbreviations used for remarks

RS = residues of the test substance

H = hemorrhages

S = staphyloma

IV = ingrowing vessels

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

The test substance caused severe damage to the eyes when instilled unchanged into the conjunctival sac of the eye of the rabbits.