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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Constituent 1
Reference substance name:
Dimethylacrolein
IUPAC Name:
Dimethylacrolein
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.