D-Xylopyranose, oligomeric, 2-octyldodecyl xylosides

Endpoint summary

Description of key information

A study to assess the irritancy potential of the test material to the skin was performed according to the following guidelines :

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

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

A study to assess the irritancy potential of the test material to the eye was performed according to the folllowing Guidelines:

• OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye Irritationl Corrosion” (adopted 24 April 2002)

• Commission Directive 92/69/EEC Method B5 Acute Toxicity (Eye Irritation)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

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.

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

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

0.7

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

1

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

1

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

ca. 0

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

other: overall at 24, 48 and 72 h

Score:

ca. 0

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

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.

Reference 2

Endpoint:

skin irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye 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

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Batch No. 270 LG
- Expiration date of the lot/batch: 28/08/2003

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: The tst iteme was stored at room temperature in the dark

FORM AS APPLIED IN THE TEST (if different from that of starting material)
- For the purpose of the study the test item was used as supplied.

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Three New Zealand White rabbits were supplied by David Percivai Ltd, Moston, Sandbach, Cheshire, UK. At the start of the study the animais were in the weight range of 2.0 to 3.5 kg and were tweive to twenty weeks oid. After an acclimatisation period of at ieast five days each animal was given a number unique within the study which was written with a black indelible marker-pen on the inner surface ofthe ear and on the cage label.
The animais were individualiy housed in suspended metal cages. Free access to mains drinking water and food (Certified Rabbit Diet (Code 5322) suppiied by International Product Supplies Limited, Wellingborough, Northants, UK) was ailowed 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 ofthe 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 fifieen changes per hour and the lighting was controlled by a time switch to give tweive hours continuous light (06:00 to 18:00) and twelve hours darkness.

The animais were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

Vehicle:

unchanged (no vehicle)

Controls:

other: other eye

Amount / concentration applied:

0.1 mL

Observation period (in vivo):

1 hour, 24, 48 and 72 hours following treatment

Number of animals or in vitro replicates:

3

Details on study design:

Immediately before the start of the test, both eyes of the provisionaily seiected test rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope. Oniy animais free of ocuiar damage were used.
Initially, a single rabbit was treated. A volume of 0.1 ml of the test material was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test material, and then released. The left eye remained untreated and was used for control purposes. Immediately afier administration of the test material, an assessment of the initial pain reaction was made according to the six point scale shown in Appendix 1.
After consideration of the ocular responses produced in the first treated animal, two additional animais were treated.
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the numerical evaluation given in Appendix 2, (from Draize J H (1977) “Dermal and Eye Toxicity Tests” In: Principles and Procedures for Evaluating the Toxicity ofHousehold Substances, National Academy of Sciences, Washington DC p.48 to 49).
Any other ocular effects were also noted. Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

0.3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

1

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

0.3

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

0.3

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

0.7

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

ca. 0

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

ca. 0

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

ca. 0

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

ca. 0

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

ca. 0

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

ca. 0

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

ca. 0

Irritant / corrosive response data:

Reversibility of any observed effect: Changes fully reversible within 3 days

Interpretation of results:

other: not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The test material produced a maximum group mean score of 8.7 and was classified as a
MILD IRRITANT (CLASS 4 ON A 1 TO 8 SCALE) to the rabbit eye according to a modified
Kay and Calandra classification system.
The test material did flot meet the criteria for classification as irritant according to EU labeiling regulations Commission Directive 200 1/59/EC.

Executive summary:

Introduction.

The study was performed to assess the irritancy potential of the test material to the eye 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. 405 “Acute Eye IrritationlCorrosion” (adopted 24 April 2002)

• Commission Directive 92/69/EEC Method B5 Acute Toxicity (Eye Irritation)

Result.

A single application of the test material to the non-irrigated eye of tbree rabbits produced minimal to moderate conjunctival irritation. Two treated eyes appeared normal at the 48-hour observation and the remaining treated eye appeared normal at the 72-hour observation.

Conclusion.

The test material produced a maximum group mean score of 8.7 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. The test material did flot meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/5 9/EC.

Reference 2

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

Executive summary:

The in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Justification for classification or non-classification

Justification for selection of skin irritation / corrosion endpoint:

A single 4-hour, semi-occluded application of the test material to the intact skin of three 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.

 No corrosive effects were noted. The test material did not meet the criteria for classification as irritant or corrosive according to the Regulation (EC) No. 1272/2008.

 

Justification for selection of eye irritation endpoint:

A single application of the test material to the non-irrigated eye of three rabbits produced minimal to moderate conjunctival irritation. Two treated eyes appeared normal at the 48-hour observation and the remaining treated eye appeared normal at the 72-hour observation.

The test material did not meet the criteria for classification as irritant according to the Regulation (EC) No. 1272/2008.