Hexanedioic acid, 1,6-bis(2-propylheptyl) ester

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japan/MAFF 8147

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

XPB 115

IUPAC Name:

XPB 115

Constituent 2

Reference substance name:

Hexanedioic acid, bis(2-propylheptyl) ester

IUPAC Name:

Hexanedioic acid, bis(2-propylheptyl) ester

Constituent 3

Reference substance name:

1,6-bis(2-propylheptyl) hexanedioate

EC Number:

940-510-9

Cas Number:

103043-58-9

Molecular formula:

C26 H50 O4

IUPAC Name:

1,6-bis(2-propylheptyl) hexanedioate

Test material form:

other: liquid

Details on test material:

refer to confidential details on test material

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Age at study initiation: Approx. 5-8 months
- Weight at study initiation: 4.22 kg – 4.91 kg
- Housing: Single housing, Stainless steel wire mesh cages with grating with shallow cage body; floor area: 4225 cm2
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3°C
- Humidity (%): 30 – 70%
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.)

IN-LIFE DATES: From: 05 May 2014 To:

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin sites of same animals used as negative control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:

4h

Observation period:

7d

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: semi- occlusive, test patch fixed with Fixomull® stretch (adhesive fleece)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4h

SCORING SYSTEM: see "any other information on materials and methodes incl. tables"

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24h - 72h

Score:

1.3

Max. score:

2

Reversibility:

fully reversible within: 7d

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24h - 72h

Score:

0.2

Max. score:

1

Reversibility:

fully reversible within: 7d

Results 3

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

mean

Time point:

other: 24h - 72h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 48h

Results 4

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean

Time point:

other: 24h - 72h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 7d

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

mean

Time point:

other: 24h - 72h

Score:

1.7

Max. score:

2

Reversibility:

fully reversible within: 7d

Results 6

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

mean

Time point:

other: 24h - 72h

Score:

0

Max. score:

0

Results 7

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

mean

Time point:

other: 24h - 72h

Score:

0.7

Max. score:

1

Reversibility:

fully reversible within: 7d

Results 8

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

mean

Time point:

other: 24h - 72h

Score:

0

Max. score:

0

Any other information on results incl. tables

readings	Animal No.	Erythema	edema
0h	1	1	0
	2	0	0
	3	0	0
1h	1	1	0
	2	0	0
	3	0	0
24h	1	1	0
	2	2	0
	3	2	0
48	1	0	0
	2	2	1
	3	2	0
72h	1	0	0
	2	2	1
	3	1	0
7d	1	-	-
	2	0	0
	3	0	0
mean 24h - 72h	1	0.3	0.0
	2	2.0	0.7
	3	1.7	0.0
mean		1.3	0.2