Registration Dossier

Diss Factsheets

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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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
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

1stanimal

2ndanimal

1stanimal

2ndanimal

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