D-Glucopyranose, oligomeric, C10-16(even numbered) alkyl glycosides

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

04 - 26 Jan 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

occlusive dressing

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

D-Glucopyranose, oligomeric, C10-16(even numbered) alkyl glycosides

EC Number:

600-975-8

Cas Number:

110615-47-9

Molecular formula:

Not applicable: UVCB

IUPAC Name:

D-Glucopyranose, oligomeric, C10-16(even numbered) alkyl glycosides

Details on test material:

- Name of test material (as cited in study report): trade name
- Physical state: yellow viscous liquid
- Purity: 60% AS

Test animals

Species:

rabbit

Strain:

other: Kleinrusse, Chbb: HM

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Weight at study initiation: 2370 g (mean)
- Housing: Individually in rabbit batteries
- Diet: Zucht-/Haltungsdiät 20 ZH 5 (Nohrlin GmbH, Bad Salzuflen, Germany)
- Water: tap water, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 45-50
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 04.01.1988 To: 26.01.1988

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g

Duration of treatment / exposure:

4 h

Observation period:

21 days
Reading time points: 1, 24, 48 and 72 h and 7, 10, 14, 17 and 21 days

Number of animals:

4

Details on study design:

TEST SITE
- Area of exposure: 6.25 cm²
- Type of wrap if used: the treated skin was wrapped with a plastic foil and an Acrylastic tape.

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 4 animals

Time point:

other: mean after 24/48/72 h

Score:

2.9

Max. score:

4

Reversibility:

fully reversible within: 17 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 4 animals

Time point:

other: mean after 2/48/72 h

Score:

2.1

Max. score:

4

Reversibility:

fully reversible within: 10 days

Remarks on result:

other: brownish discolouration was observed up to 3 days post-application; eschar formation was observed between Days 7 to 21

Irritant / corrosive response data:

Moderate skin erythema and edema as well as eschar formation were observed after treatment. These reactions were fully reversible within 17 days.

Other effects:

No further local or systemic effects were observed.

Any other information on results incl. tables

Table 1. Results of skin irritation study

Observation time	Rabbit no.
	1		2		3		4
	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema
1 h	1	0	1	0	1	0	1	0
24 h	3	2 B	3	2	2	1	3	2
48 h	3	2 B	3	2	3	2	3	2 B
72 h	3	3 B, A	3	3 B	3	2	3	2 B

B = brownish discolouration; A = cracked skin

Table 2. Calculation of mean scores

	Rabbit no.
	1		2		3		4
	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema
Mean value 24 + 48 + 72 h*	3	2.33	3	2.33	2.67	1.67	3	2

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: Skin irrit 2, H315
DSD: Xi, R38