9-Octadecenedioic acid

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: see 'Remark'

Remarks:

GLP - Guideline study. Tested with the source substance (Z)-9-octadecen-1,18-dioic acid (CAS 20701-68-2). In accordance with the ECHA guidance document "Practical guide 6: How to report read-across and categories (2012)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted Jul 2015

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(Z)-9-Octadecene-1,18-dioic acid

Cas Number:

20701-68-2

Molecular formula:

C18H32O4

IUPAC Name:

(Z)-9-Octadecene-1,18-dioic acid

Constituent 2

Reference substance name:

(Z)-9-Octadecen-1,18-dioic acid

IUPAC Name:

(Z)-9-Octadecen-1,18-dioic acid

Details on test material:

- Name of test material (as cited in study report): C18:1 dicarboxylic acid
- Physical state: dark yellow solid
- Analytical purity: ca. 90%
- Lot/batch No.: L93046
- Expiration date of the lot/batch: 1 Jan 1997
- Storage condition of test material: at room temperature in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Broekman Institute, Someren, the Netherlands
- Age at study initiation: approximately 8 weeks
- Weight at study initiation: 1594 - 1867 g
- Housing: individually in cages with perforated floors (Scanbur Denmark)
- Diet: LKK-20 laboratory rabbit diet (Hope Farms, Woerden, the Netherlands), approximately 100 g/day; hay once per week
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g moistened with water

Duration of treatment / exposure:

4 h

Observation period:

72 h
Reading time points: 1, 24, 48 and 72 h

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: 6 cm² on the dorsal area of the trunk
- Type of wrap if used: the test are was covered with a non-woven patch mounted on Micropore tape, which was wrapped around the abdomen and secured with elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the remaining test substance was removed using a tissue moistened with tap water and subsequently the skin was wiped with a dry tissue
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: mean after 24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: mean after 24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

At the 1-h reading time point, very slight to well defined erythema (score 1-2) was observed in 3/3 rabbits and very slight edema (score 1) was noted in 2/3 rabbits. At the 24-h reading time point, 3/3 animals had very slight erythema (score 1), while the edema had cleared completely. All skin irritation effects had cleared within 48 h after patch removal.

Other effects:

There was no mortality and no treatment-related clinical signs were observed.

Any other information on results incl. tables

Table 1. Results of skin irritation study

Observation time	Rabbit no.
	1		2		3
	Erythema	Edema	Erythema	Edema	Erythema	Edema
1 h	2	0	2	1	1	1
24 h	1	0	1	0	1	0
48 h	0	0	0	0	0	0
72 h	0	0	0	0	0	0
Mean value 24 + 48 + 72 h	0.33	0	0.33	0	0.33	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified