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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Eye irritation

Currently viewing:

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: acceptable, well documented study report which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Principles of method if other than guideline:
Method: Draize Test
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Di-''isononyl'' phthalate
EC Number:
249-079-5
EC Name:
Di-''isononyl'' phthalate
Cas Number:
28553-12-0
Molecular formula:
C26H42O4
IUPAC Name:
1,2-benzenedicarboxylic acid, di-isononyl ester
Constituent 2
Reference substance name:
DINP
IUPAC Name:
DINP
Details on test material:
Palatinol N

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: GAUKLER 6050 OFFENBACH / MAIN
- Housing: 1 animal/cage
- Diet (e.g. ad libitum): OVATOR SOLIKANIN 4 MM ; MUSKATOR-WERKE 4000 DUESSELDORF-1 (daily about 130 G/animal)
- Water (e.g. ad libitum): daily about 250 ML/animal:
- Acclimation period: about 8 days before start of study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26 °C
- Humidity (%): 50 - 80 %
- Photoperiod (hrs dark / hrs light): 12 H/12 H (6.00 - 18.00 H/18.00 - 6.00 H)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
0.1 ml, single application into the conjunctival sac of the right eye, the substance is not washed off
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
2 males, 4 females

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: n.a.
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: n.a.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.28
Max. score:
3
Reversibility:
fully reversible within: 2 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation

Any other information on results incl. tables

Readings

Animal

Cornea

Iris

Conjunctiva

Additional findings

op

ar

red

ch

di

24 h

1

0

0

0

1

0

0

 

2

0

0

0

1

0

0

 

3

0

0

0

1

0

0

 

4

0

0

0

1

0

0

 

5

0

0

0

0

0

0

 

6

0

0

0

1

0

0

 

48 h

1

0

0

0

0

0

0

 

2

0

0

0

0

0

0

 

3

0

0

0

0

0

0

 

4

0

0

0

0

0

0

 

5

0

0

0

0

0

0

 

6

0

0

0

0

0

0

 

72 h

1

0

0

0

0

0

0

 

2

0

0

0

0

0

0

 

3

0

0

0

0

0

0

 

4

0

0

0

0

0

0

 

5

0

0

0

0

0

0

 

6

0

0

0

0

0

0

 

Mean

24-72 h

1-6

0

0

0

0.28

0

0

 

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU