Isostearic acid, esters with methyl α-D-glucoside

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2008-08-19 to 2008-09-06

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: - Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

2002

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2004

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Version / remarks:

August, 1988

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No. 8147, November 2000

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Isostearic acid, esters with methyl α-D-glucoside

EC Number:

700-680-5

Molecular formula:

Molecular formula cannot be given as substance is a mixture.

IUPAC Name:

Isostearic acid, esters with methyl α-D-glucoside

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan France SARL, Gannat, France
- Age at study initiation: at least 6 weeks
- Weight at study initiation: at least 1 kg
- Housing: in controlled environment, individual cages with perforated floors (Scanbur, Denmark, dimensions: 56x44x37.5 cm)
- Diet: pelleted diet for rabbits (K-H from SSNIFF Spezialdiäten GmbH, Soest, Germany), approx 100 g/day. Hay (TecniLab-BMI BV, Someren, The Netherlands) was provided at least three times a week.
- Water: ad libitum, tap water
- Acclimation period: at least 5 days before treatment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): The test substance was applied as delivered by the sponsor.

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

3 animals

Details on study design:

The study was performed in a stepwise manner and was started by treatment of a single rabbit. The two others were treated in a similar manner 2 weeks later, after considering the degree of skin irritation observed in the first animal.

Approx. 24 h before treatment, the dorsal fur was clipped with electric clippers, exposing an area of approx. 150 cm2 (10x15 cm). To facilitate scoring, treated skin areas were re-clipped at least 3 hours before the observations.

TEST SITE
- Area of exposure: one flank, using a metalline patch 2x3 cm
- Type of wrap if used: The patch was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin cleaned using tap water and watery ethanol (50 % v/v).
- Time after start of exposure: 4 h

OBSERVATION
- Mortality/Viability: twice daily
- Body weight: day of treatment (prior to application) and at termination

HISTOPATHOLOGY
- no histopathology was performed

SCORING SYSTEM:
Erythema and eschar formation:
- No erythema: 0
- Very slight erythema (barely perceptible): 1
- Well-defined erythema: 2
- Moderate to severe erythema: 3
- Severe erythema (beet redness): 4 (Where signs of necrosis or corrosion (injuries in depth) prevent erythema scoring, the max. grade for erythema (=4) was given.

Oedema formation:
- No edema: 0
- Very slight oedema (barely perceptible): 1
- Slight oedema (edges of area well-defined by definite raising): 2
- Moderate oedema (raised approx. 1 mm): 3
- Severe oedema (raised more than 1 mm and extending beyond the area of exposure): 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24, 48, 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: scaliness on day 72h to 7 d

Results 2

Irritation parameter:

erythema score

Basis:

animal: # 2, 3

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Results 3

Irritation parameter:

edema score

Basis:

animal: # 1, 2, 3

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

- Very slight erythema in the treated skin areas of all three animals after 60 minutes, which had resolved within 24 h after exposure in two animals and within 7 days after exposure in one animal.
- Scaliness in the treated skin area of one animal was noted at 72 hours and 7 days post-treatment and had resolved within 14 days.
- Dry remnants of the test substance were present on the skin of two animals on day 1.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Erythema	Edema
	Max. score: 4	Max. score: 2
60 min	1/1^b/1^b	0/0/0
24 h	1/0/0	0/0/0
48 h	1/0/0	0/0/0
72 h	1c/0/0	0/0/0
7 d	0^c/-/-	0/-/-
14 d	0/-/-	0/-/-
Average 24h, 48h, 72h (mean per animal)	1/0/0	0/0/0
Reversibility*)	c.	c.
Average time (unit) for reversion	24 h	-

- First animal sentinel

*) Reversibility: c.= completely reversible, n.c.= not completely reversible; n.= not reversible

b) Dry remnants of the test substance present

c) Scaliness

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Based on the results of this study the test substance is not irritating to the skin.

Executive summary:

In a primary dermal irritation study according to OECD Guideline 404 three young adult male New Zealand White rabbits were dermally exposed to 0.5 g of Isostearic acid, esters with methyl α-D-glucoside as supplied by the sponsor for 4 hours, under semi-occlusive dressing. The animals then were observed for 14 days. Irritation was scored by the method described in OECD Guideline 404.

Very slight erythema in the treated skin areas of all three animals was observed after 60 minutes, which had resolved within 24 h after exposure in two animals and within 7 days after exposure in one animal. Scaliness in the treated skin area of one animal was noted at 72 hours and 7 days post-treatment and had resolved within 14 days.

In this study Isostearic acid, esters with methyl α-D-glucoside is not a dermal irritant.