Undecyl glucoside

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

8 - 11 Dec 1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The non-GLP study was performed equivalent to an appropriate OECD guideline. Only 10% active ingredient (a.i.) tested

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

Journal Officiel de la Republique Francaise (1982)

Deviations:

yes

Remarks:

10% a.i. tested, reading time points 24 and 72 h only, limited study design information

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Undecyl glucoside

EC Number:

308-766-0

EC Name:

Undecyl glucoside

Cas Number:

98283-67-1

Molecular formula:

(C6H10O5)nC11H24O, n - number of D-glucopyranose units

IUPAC Name:

(2R,3S,4S,5R)-2-(hydroxymethyl)-6-(undecyloxy)oxane-3,4,5-triol

Test material form:

other: fluid gel, not further specified

Test animals

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

no data

Test system

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

other: distilled water

Controls:

other: untreated sites of the same animal served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration: 55% a.i. product diluted to 18.2%, (i.e. 10% a.i.)

Duration of treatment / exposure:

no data

Observation period:

Reading time points: 24 and 72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 0.5 mL of the solution was laid down on a square gauze which was immediately applied on the skin of each rabbit.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: mean over 24, 48 and 72 hours

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: No scoring was performed after 48 h, therefore, the same irritation scores as after 24 hours were assumed

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: mean over 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: No scoring was performed after 48 h, therefore, the same irritation scores as after 24 hours were assumed

Irritant / corrosive response data:

Slight erythema formation (grade 1) was recorded in all animals 24 h after start of exposure. These effects were fully reversible in all animals within 72 hours. No edema formation was detected in any animal.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

Under the experimental conditions performed equivalent or similar to OECD TG 404 the test material appeared to be not irritating to skin when applied as 18.2% (10% a.i.) formulation.

SCL (worst case assumption due to lack of data for neat substance):
Not irritating ≤10% (a.i.)
Skin Irrit. Cat. 2 >10% (a.i.)