Diisobutyl phthalate

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

- Animals were treated for 1, 5, and 15 min or 20 hours using occlusive conditions; - Skin tissue from the ear was also tested; - The test substance was washed out with water (which sometimes contained a mild detergent) after the exposure period. (BASF

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

Species:

rabbit

Strain:

other: white vienna rabbits

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: white vienna rabbits were used as test species.
- Age at study initiation: young adult animals
- Weight at study initiation: 2.97 - 3.13 kg
No additional details provided

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

Approximately 1 ml test substance was applied on the right dorsal/lateral flank. NaCl was used as control and was applied on the left dorsal/lateral flank.

Duration of treatment / exposure:

20 hour(s)

Observation period:

the animals were observed for 7 days and skin changes were recorded on working days.

Number of animals:

2

Details on study design:

TEST SITE
- Area of exposure: an application site of 2.5 x 2.5 cm was covered with the test substance. In addition, skin tissue from the ear was tested.
- Type of wrap if used: occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after the applikation time the sites were wiped with water, containing a mild detergent.
- Time after start of exposure: 20 hours

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

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24-72-hour

Score:

0.5

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: erythema score (1) remained in one animal after 7 days (with scaling formation), but was declining

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24-72-hour

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: no edema formation was observed during the course of this study

Irritant / corrosive response data:

see below (table 1 & 2)

Other effects:

Scale formation was still observable at the end of the study (day 7) in one animal.

Any other information on results incl. tables

Table 1: Erythema / Edema scores

Time point	Individual and mean erythema / edema scores
	Erythema		Edema		Mean all animals
	1^stanimal	2^ndanimal	1^stanimal	2^ndanimal	Erythema	Edema
24 h	0	0	0	0	0.0	0.0
48 h	0	0	0	0	0.0	0.0
72 h	1	2	0	0	1.5	0.0
8 days	0	1 (scaling)	0	0	0.5	0.0
Mean 24-48-72 h	0.3	0.7	0.0	0.0	0.5	0.0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS