Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report Date:
1971

Materials and methods

Principles of method if other than guideline:
Before OECD Guideline 405 was established, eye irritation was tested using an internal method (BASF test).

GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Dimethylacrolein, 80% 3-methyl-2-butenal, 20% 3-methylbut-3-en-1-ol

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: 2.66 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
- undiluted
- amount applied: 0.05 ml
Duration of treatment / exposure:
8 days
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): none

SCORING SYSTEM:
Score Eye-irritation:
Cornea: opacity:
1 slight
2 moderate
3 strong
4 severe

Cornea: area:
1 1 ≤ 1/4
2 ≥ 1/4; < 1/2
3 ≥ 1/2; < 3/4
4 ≥ 3/4

Conjunctiva - reddening:
1 slight reddening
2 clear visible reddening
3 strong

Conjunctiva – chemosis:
1 slight
2 moderate
3 strong

Iris:
1 vascularization (ciliar injections)
2 iritis (inflammation of iris) - haemorrhage


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks on result:
other: opacitiy
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks on result:
other: reddening
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
1.16
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: chemosis
Irritant / corrosive response data:
Finding after 1 hr: Slight erythema, very distinct edema, distinct corneal opacity was seen. Findings after 24 hrs: Erythema, edema, opacity persisted. Hemorrhages. Findings after 8 days: Distinct erythema, slight edema, persistent distinct opacity. Ingrown blood vessels, staphyloma.

Any other information on results incl. tables

Readings

Animal

Cornea

Iris

Conjunctiva

Additional findings

op

ar

red

ch

di

1 h

1

2

1

3-4

PC

2

2

1

3-4

PC

24 h

1

2

2

2

cill. injections

2

2

2

2

haemorrhage, cill. injections

48 h

1

2

2

1

haemorrhage, cill. injections

2

2

2

1

haemorrhage, cill. injections

72 h

1

2

2

1

haemorrhage

2

2

2

0

haemorrhage

8 d

1

2

2

1

iritis, ingrowing vessels, MV staphyloma , LH

2

1

1

0

Mean

24 -72 h

1

2

2

1.33

2

2

2

1

Mean

24-72 h

1-2

2

2

1.16

Symbols:

LH: Loss of hair at margins of eyelids

MV: Marginal vascularization of the cornea

PC: Pupil contracted


Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information R 41 Criteria used for interpretation of results: EU
Conclusions:
Severe eye irritation, staphyloma, persistent corneal
opacity. Risk of persistent severe eye lesions upon contact
to the eyes.