2-Hydroxypropyl-β-cyclodextrine ethers

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Myrtle's Rabbitry, Thompson Station, TN
- Age at study initiation: Adult
- Weight at study initiation:4714g (M), 4722g (M), 4741g (F)
- Fasting period before study: one day
- Housing: housed individually in suspended stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum of five days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 67-69
- Humidity (%): 51-67
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

TEST SITE
- Area of exposure: dorsal area of the trunk
- Type of wrap if used: elastic wrap

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gauze moistened with distilled water followed by dry gauze

TEST MATERIAL
- Amount(s) applied: 0.50g/rabbit
- Concentration (if solution): 100%
- Constant volume or concentration used: yes

Duration of treatment / exposure:

7 days

Number of animals:

3 (2M. 1F)

Details on study design:

Preliminary Procedures: On day -1 t the animals chosen for use on the primary skin irritation study had the fur removed from the dorsal area of the trunk using an animal clipper. Care was taken to avoid abrading the skin during the clipping procedure.
Day 0: the test article was applied to a small area of intact skin on each test animal (approximately 1 inch x 1 inch).

The test site was wiped with gauze moistened with distilled water. The test article was then administered to the moistened test site under the gauze patch. The gauze patch was held in contact with the skin at the cut edges with a nonirritating tape. Removal and ingestion of the test article was prevented by placing an elastic wrap over the trunk and test area (semi-occlusive binding). The elastic wrap was then further secured with adhesive tape around the trunk at the cranial and caudal ends.
After dosing, collars were placed on each animal and remained in place until removal on day 3. After a four-hour exposure period, the elastic wrap and gauze patch were removed from each animal and the corners of the test site delineated using a marker. Residual test article was removed using gauze moistened with distilled water followed by dry gauze.

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.66

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Other effects:

very slight to well-defined erythema; very slight to slight edema; superficial lightening

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this test, hydroxypropylated .beta.-cyclodextrin is considered to be a slight irritant to the skin of the rabbit.

Executive summary:

The potential irritant effects of hydroxypropylated .beta.-cyclodextrinwere evaluated on the skin of New Zealand White rabbits. Each of three rabbits received a 0.50gdose of the test article as a single dermal application. Each test site was moistened with distilled water to enhance test article contact with the skin. The dose was held in contact with the skin under a semi-occlusive binder for an exposure period of four hours. Following the exposure period, the binder was removed and the remaining test article was wiped from the skin using gauze moistened with distilled water followed by dry gauze. Test sites were subsequently examined and scored for dermal irritation for up to 7 days following patch removal.

Exposure to the test article produced very slight to well-defined erythema on 3/3 test sites and very slight to slight edema on 2/3 test sites at the 1 hour scoring interval. The dermal irritation resolved completely in all animals by study day 7. Additional dermal findings included superficial lightening, which was noted on 1/3 test sites.

Under the conditions of this test, hydroxypropylated .beta.-cyclodextrinis considered to be a slight irritant to the skin of the rabbit. The calculated Primary Irritation Index for the test article was 1.50.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

Structural similarity.

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

< 1

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

< 1

Max. score:

4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

< 1

Max. score:

4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

< 1

Max. score:

4

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available