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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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