Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: comparable to guidelines/standards

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
only 2 animals tested; 50µl instead of 100µl instilled; no observation point after 72 hours, Maximum observation time was 8 days
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Isobutyric anhydride
EC Number:
202-603-6
EC Name:
Isobutyric anhydride
Cas Number:
97-72-3
Molecular formula:
C8H14O3
IUPAC Name:
isobutyric anhydride
Details on test material:
- Physical state: liquid
no further data provided

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: mean: 3.08 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: treatment of the control eye with physiol. saline
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl
- Concentration (if solution): unchanged

Duration of treatment / exposure:
not washed out
Observation period (in vivo):
1, 24, 48 hours and after 8 days
Number of animals or in vitro replicates:
2 male rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize (re-evaluation according to the scoring system of Draize as recommended by the actual guideline requirements

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
all animals
Time point:
other: 24 and 48 hours
Score:
1.8
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
mean
Remarks:
all animals
Time point:
other: 24 and 48 hours
Score:
0.5
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
all animals
Time point:
other: 24 and 48 hours
Score:
1.8
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
all animals
Time point:
other: 24 and 48 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days

Any other information on results incl. tables

Table 1: Individual results:

Readings

Animal

Cornea

Iris

conjunctiva

Symptoms

opacity

redness

swelling

discharge

1 h

1

1

0

2

2

2

 

2

1

0

2

2

2

 

24 h

1

1

0

1

2

1

 

2

2

0

2

2

1

 

48 h

1

2

1

2

2

3

 

2

2

1

2

2

3

Na

8d

1

1

0

1

0

1

 

2

1

0

1

0

0

Na

mean 24 - 48 h

1

1.5

0.5

1.5

2.0

2.0

 

2

2.0

0.5

2.0

2.0

2.0

 

mean

 

1.8

0.5

1.8

2.0

2.0

 

Na: Scar

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information