Dibutyl phthalate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (GLP, QAU)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Dibutyl phthalate

EC Number:

201-557-4

EC Name:

Dibutyl phthalate

Cas Number:

84-74-2

Molecular formula:

C16H22O4

IUPAC Name:

dibutyl phthalate

Details on test material:

- Physical state: liquid, clear, achromatic
- Analytical purity: 99,4%
- Lot/batch No.: P. 66 A/89
- Stability under test conditions: on completion of all tests, the stability of the substance was verified by a repeated analysis
- Storage condition of test material: at room temperature
- Other: the sample appeared to be homogeneous

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: White Vienna animals from Gaukler; D-6050 Offenbach/Main, FRG
- Age at study initiation: young adult animals
- Weight at study initiation: mean bw of 3.26 kg for males (2) and 3.69 kg for female (1)
- Housing: one animal per cage in cages made of stainless steel with wire mesh walk floors (floor area : 40 cm x 51 cm)
- Diet (e.g. ad libitum): Kliba 341, 4 MM; from Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water (e.g. ad libitum): about 250 ml tap water per animal per day
- Acclimation period: at least 8 days before the beginning of the study

ENVIRONMENTAL CONDITIONS
The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a temperature range and a relative humidity. There were no deviations from these ranges which influenced the results of the study.
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Single application of test substance into the conjunctival sac of the right eye.

Duration of treatment / exposure:

72 hour(s)

Observation period (in vivo):

up to 3 days

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not rinsed

SCORING SYSTEM: OECD scoring system
Readings after 1, 24, 48 and 72 hours.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

opacity

Basis:

mean

Remarks:

of all animals tested

Time point:

other: 24-48-72-hour

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Remarks:

of all tested animals

Time point:

other: 24-48-72-hour

Score:

1.1

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of all tested animals

Time point:

other: 24-48-72-hour

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 4

Irritation parameter:

iris score

Basis:

mean

Remarks:

of all tested animals

Time point:

other: 24-48-72-hour

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Irritant / corrosive response data:

All irritation reactions (only conjunctivae redness) were minimal (see Table 1) and reversible within 72 hours.

Other effects:

None observed

Any other information on results incl. tables

Table 1: Results acute eye irritation (OECD scoring system) 

period	Animal	Corneal opacity	Iris	Conjunctivae
				Redness	Swelling (chemosis)
1 Hour after treatment	1	0	0	2	0
	2	0	0	2	0
	3	0	0	2	0
Mean 1 hour (3 animals)		0.0	0.0	2	0.0
24 Hour after treatment	1	0	0	2	0
	2	0	0	2	0
	3	0	0	2	0
Mean 24 hour (3 animals)		0.0	0.0	2	0.0
48 Hour after treatment	1	0	0	2	0
	2	0	0	1	0
	3	0	0	1	0
Mean 48 hour (3 animals)		0.0	0.0	1.3	0.0
72 Hour after treatment	1	0	0	0	0
	2	0	0	0	0
	3	0	0	0	0
Mean 72 hour (3 animals)		0.0	0.0	0.0	0.0
Mean 24-48-72-Hour	1	0.0	0.0	1.3	0.0
	2	0.0	0.0	1.0	0.0
	3	0.0	0.0	1.0	0.0
Mean 1 hour (3 animals)		0.0	0.0	1.1	0.0

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: EU GHS