Diisobutyl phthalate

Eye irritation

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: Scientifically acceptable well documented study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1959

Report date:

1959

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

0.05 ml of the test substance was applied to the eye (BASF test).

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Diisobutyl phthalate

EC Number:

201-553-2

EC Name:

Diisobutyl phthalate

Cas Number:

84-69-5

Molecular formula:

C16H22O4

IUPAC Name:

diisobutyl phthalate

Details on test material:

- Name of test material (as cited in study report): Palatinol IC (di-iso-butylphthalate; test substance number: IX/418)
- Molecular weight (if other than submission substance): 278
- Physical state: clear fluid
- Analytical purity: no data
No additional data provided

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

Two young male white vienna rabbits (ca. 2.48 kg and 2.55 kg) were used for the experiment.
No additional details provided

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: left eye of the same animal treated with NaCl

Amount / concentration applied:

Approximately 0.05 ml test substance was instilled into the right eye. NaCl was used as control and was instilled into the left eye.

Duration of treatment / exposure:

test substance not washed 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): none

SCORING SYSTEM: similar to the OECD scoring system; the original BASF grading was converted into the numerical grading according to the OECD Draize system.

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

erythema

Basis:

mean

Remarks:

of the 2 tested animals

Time point:

other: 24-48-72 hours

Score:

0

Max. score:

3

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: erythema (1) was observed in both animals after 1 hour, but was reversible within 24 hours

Results 2

Irritation parameter:

cornea opacity score

Remarks:

opacity

Basis:

mean

Remarks:

of the 2 tested animals

Time point:

other: 24-48-72 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of the 2 tested animals

Time point:

other: 24-48-72 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 4

Irritation parameter:

iris score

Basis:

mean

Remarks:

of the 2 tested animals

Time point:

other: 24-48-72 hours

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Irritant / corrosive response data:

see below (table 1) for erythema scores; no changes were observed in cornea opacity, conjunctiva chemosis or on the iris.

Other effects:

no other findings

Any other information on results incl. tables

Table 1: Erythema scores (conjunctiva) for the 2 test animals

Test animal	Erythema score after
	1 hour	24 hours	48 hours	72 hours	Mean 24-48-72 hours
Firs	1	0	0	0	0.0
Second	1	0	0	0	0.0
Mean	0.0	0.0	0.0	0.0	0.0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS