Reaction product of adipic acid and sebacic acid and isotridecan-1-ol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study, read-across

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adapted May 12, 1981

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

; version from September 19, 1984

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Diisotridecyl adipate

EC Number:

247-660-8

EC Name:

Diisotridecyl adipate

Cas Number:

26401-35-4

IUPAC Name:

bis(11-methyldodecyl) adipate

Details on test material:

- Name of test material (as cited in study report): Glissofluid A 13
- Physical state: colorless liquid
- Analytical purity: 99.67%
- Lot/batch No.: 18 A/91
- Stability under test conditions: stable
- Storage condition of test material: room temperature

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system 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

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

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.