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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adapted May 12, 1981
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
; version from September 19, 1984
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): diisotridecyl adipate

In vitro test system

Details on animal used as source of test system:
old study

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler, 6050 Offenbach, FRG
- Age at study initiation: young adults
- Weight at study initiation: 2.83 - 2.98 kg
- Housing: fully air conditioned rooms; single housing in stainless steel cages with wire mesh walk floors, area 40 cm x 51 cm; no bedding in cages, sawdust in the waste trays
- Diet (e.g. ad libitum): KLIBA Labordiät 341, 4 mm; Klingenthalmühle AG, Kaiseraugst, Switzeland; ca. 130 g per animal and day
- Water (e.g. ad libitum): tap water, ca. 250 mL per animal and day
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 30 - 70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated area on the test animals
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL, test substance was applied to the test patch (2.5 cm x 2.5 cm) and the test patch was secured to the animals skin with a semiocclusive dressing.
Duration of treatment / exposure:
4 h
Observation period:
8 d
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorsal area (2.5 cm x 2.5 cm), upper third of the back or flanks
- % coverage: no data
- Type of wrap if used: test patch: Idealbinde, Pfälzische Verbandstoff-Fabrik, Kaiserslautern, Germay; adhesive tape: Fixomull Stretch (adhesive fleece) Beiersdorf AG

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes; with Lutrol E 400 (Polyethylenglycol DAB) and Lutrol / water 1 : 1
- Time after start of exposure: 4 h

SCORING SYSTEM: according to table in OECD TG 404 (Draize system)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, and 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, and 72 h
Score:
0
Max. score:
4
Remarks on result:
other: no effects observed
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, and 72 h
Score:
0.667
Max. score:
4
Reversibility:
fully reversible within: 8 d
Irritation parameter:
erythema score
Basis:
other: mean of animal 2 and 3
Time point:
other: 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h

Any other information on results incl. tables

Skin reactions following a single topical application of 0.5 mL of diisotridecyl adipate to rabbits (grading according to OECD TG 404)

 

Animal

Skin reaction

After patch removal

1 h

24 h

48 h

72h

Mean
(24-72 h)

8 d

1

Erythema

0

0

1

1

0.667

0

Edema

0

0

0

0

-

0

2

Erythema

1

0

0

0

-

0

Edema

0

0

0

0

-

0

3

Erythema

1

0

0

0

-

0

Edema

0

0

0

0

-

0

 

 

None of the animals showed an edema reaction at any time point. Very slight edema (grade 1) were seen in all animal. In animal 2 and 3, erythema (visible at the 1 h reading) had subsided after 24 h. Animal 1 displayed a delayed reaction. But the effect observed at 48 h and 72 h was reversible within 8 days.

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Diisotridecyl adipate showed only a very weak response in a primary dermal irritation test (only erythema grade 1, fully reversible within 1 to 8 d). Based on the results of the test performed, diisotridecyl adipate is not irritating
Executive summary:

In a primary dermal irritation study, 3 male young adult White Vienna rabbits were dermally exposed to 0.5 mL diisotridecyl adipate. The test substance was administered for 4 h soaked on a test patch of 2.5 x 2.5 cm and held in place by semiocclusive dressing. Animals then were observed for 8 days. Irritation was scored according OECD test guideline 404.

 

For all three rabbits, only very slight erythema were observed. They fully disappeared with 1 to 8 days. Edema were not observed at all after treatment.

 

In this study, diisotridecyl adipate is not irritating to the skin of rabbits (Rossbacher/BASF, 1992a).

 

This study is assessed as acceptable. It satisfies the guideline requirements (OECD TG 404) for an acute dermal irritation/corrosion study.