D-Xylopyranose, oligomeric, 2-octyldodecyl xylosides

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

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

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

apx 20P

IUPAC Name:

apx 20P

Details on test material:

Sponsor’s identification : APX 20 P
Description : brown paste
Batch number : 270 LG
Date receved : 12 December 2002
Storage conditions : room temperature in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Three New Zealand White rabbits were supplied by David Percivai Ltd, Moston, Sandbach, Cheshire, UK. At the start ofthe study the animais were in the weight range of 2.0 to 3.5 kg and were twelve to twenty weeks oid. After an acclimatisatjon period of at ieast five days each animai was given a number unique within the study which was written with a black indelibie marker-pen on the inner surface ofthe ear and on the cage label.

The animals were individuaily housed in suspended metal cages. Free access to mains drinking water and food (Certified Rabbit Diet (Code 5322) supplied by International Product Supplies Limited, Weiiingborough, Northants, UK) was aliowed throughout the study. The diet and drinking water were considered flot to contain any contaminant of a level that might have affected the purpose or integrity of the study.

The temperature and relative humidity were set to achieve limits of 17 to 23°C and 30 to 70% respectively. Any occasional deviations from these targets were considered flot to have affected the purpose or integrity of the study. The rate of air exchange was at ieast fifteen changes per hour and the iighting was controlied by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
The animais were provided with envirournental enriciiment items which were considered not to contain any contaminant of a levei that might have affected the purpose or integrity of the study.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

1 mg

Duration of treatment / exposure:

4 h

Observation period:

up to 7 days

Number of animals:

3

Details on study design:

On the day before the test each of a group of three rabbits was clipped free of fur from the dorsal/flai,Jc area using veterinary clippers. Only animais with a healthy intact epidermis by gross observation were seiected for the study.
On the day of the test a suitabie test site was seiected on the back of each rabbit. A quantity of 0.5 ml of the test materiai was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and piaced in position on the shorn skin. The patch was secured in position with a strip of surgical adhesive tape. To prevent the animais interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset and the animais were returned to their cages for the duration of the exposure period.
Four hours after application the corset and patches were removed from each animal and any residuai test material removed by gentie swabbing with cotton wool soaked in 74% Industrial Methylated Spirits.
Approximateiy one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

0.7

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

1

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

1

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

ca. 0

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 h

Score:

ca. 0

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

1

Irritant / corrosive response data:

Reversibility of any observed effect: Changes fully reversible within 7 days

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The test material produced a primary irritation index of 1.2 and was classified as a MILD IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test material did flot meet the criteria for classification as irritant or corrosive according to the EU labelling regulations Commission Directive 2001/59/EC.

Executive summary:

Introduction.

The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method was designed to meet the requirements of the following:

• OECD Guidelines for the Testing of Chemicals No. 404 “Acute Dermal IrritationlCorrosjon” (adopted 24 April 2002)

• Commission Directive 92/69/EEC Method B4 Acute Toxicity (Skin Irritation)

Results.

A single 4-hour, semi-occluded application ofthe test material to the intact skin ofthree rabbits produced very slight erythema and very slight oedema. Loss of skin elasticity was also noted at two treated skin sites. One treated skin site appeared normal at the 72-hour observation and the remaining two treated skin sites appeared normal at the 7-day observation.

Conclusion.

The test material produced a primary irritation index of 1.2 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted. The test material did flot meet the criteria for classification as irritant or corrosive according to the EU labelling regulations Commission Directive 2001/59/EC.