Reaction products of behenic acid, Eicosadioic acid and Polyglyceryl-10

Endpoint summary

Description of key information

One Guideline study on skin irritation, in vivo

One Guideline study on eye irritation, in vivo

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:

key study

Study period:

10. December 2007 - 18. January 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 5-4-A
- Expiration date of the lot/batch: October 2008
- Purity test date: not stated

RADIOLABELLING INFORMATION (if applicable)
not applicable

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperater, light protected
- Stability under test conditions: stable under storage conditions
- Solubility and stability of the test substance in the solvent/vehicle: not applicable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
none

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Netherlands BV
- Age at study initiation: 12 weeks (male) 11-12 weeks (female)
- Weight at study initiation: 2052 - 2147 g
- Housing: individually
- Diet (e.g. ad libitum): ad libitim
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

14 or 16 pellets of Nomcort HKP, placed on surgical gauze patch to cover an area of approx. 6 cm2

Duration of treatment / exposure:

4

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm2
- % coverage: not stated
- Type of wrap if used: semi-occlusive dressing, fixed with tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm water
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
1, 24, 48 and 72 hours
(indicate if minutes, hours or days)

SCORING SYSTEM:
- Method of calculation: according to Guideline

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Other effects:

no other effects reported

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, Nomcort HK-P is not a skin irritant.

Executive summary:

The primary skin irritation potential of Nomcort HK-P was investigated according to OECD test guideline no. 404. The test item was applied by topical semi-occlusive application on an area of approximately 6 cm2 to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. the scoring of skin reaction was performed 1, 24, 48 and 72 hours after removal of the dressing.

The mean score was calculated across 3 scoring times (24, 48 and 72 hours afterpatch removal) for each animal for erythema/eschar grades and for oedema grades, separately.

The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0.

The test item caused no staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed.

Thus, the test item did not induce significant or irreversible damage to the skin.

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:

experimental study

Adequacy of study:

key study

Study period:

19. June - 23 June 2000 (experimental interval)

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

This test was designed to detennine the ocular irritation potential of substances in the non-rinsed
eyes of three (3) rabbits. The procedure is a modification of that desciibed by J.H. Draize (J.H. Draize, "Deimal Toxicity", Appraisal of the Safety of Chemicals in Foods, Drugs and
Cosmetics, (The Association of Food and Drug Officials of the United States, 1959), pp. 49 - 51.). This protocol was designed to satisfy the requirements of the Japanese Ministry of Health and
Welfare.

GLP compliance:

no

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 0-3-A
- Expiration date of the lot/batch: not stated
- Purity test date: not stated


RADIOLABELLING INFORMATION (if applicable)
not applicabble

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: not stated
- Stability under test conditions: not stated
- Solubility and stability of the test substance in the solvent/vehicle: not applicable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
not stated

Test Article is described as liquid

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Three (3), female, New Zealand white rabbits weighing approximately two (2) kilograms and
about three (3) months of age, were used for each test atiicle. The animals were obtained
through a suitably licensed dealer. The animals were checked carefully upon receipt for ocular
defects, diarrhea and dehydration, respiratory difficulties, postural deficiencies, and general
condition. Any animal exhibiting visible ocular defects or irritation, or poor condition, was
rejected.
The animals were acclimated for five (5) days prior to test initiation. They were individually
housed in stainless steel cages, in a temperature controlled room, with a 12 hour light/dark cycle
and identified through individual markings on the outer ear of each animal, as well as a cage
label. The room temperature was controlled to comply with Animal Welfare Regulations with an
approximate range of 65° to 15° F. The humidlity was also monitored. Diet consisted of Lab
Diet Certified Rabbit Diet #5322, at 100 grams per day per animal. Water was provided ad
libitum.

Vehicle:

water

Controls:

not required

Amount / concentration applied:

0.1 ml of 20 % solution.

Duration of treatment / exposure:

24 hour before washing

Observation period (in vivo):

at 1, 24, 48 and 72 hours

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): if necessary, washing is done after 24 hours
- Time after start of exposure: 24 hours

SCORING SYSTEM:

comparable to Guideline:
A Opacity (0-4)
B Area of Cornea involved (0-4)
C Iris (0-2)
D Conjunctivae Redness (0-3)
E Conjunctivae Chemosis (0-4)
F Conjunctivae Discharge (0-3)

Total score = (A*B*5)+(C*5)+((A+B+C)*2) = 110

TOOL USED TO ASSESS SCORE: not stated

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

0.7

Max. score:

110

Reversibility:

fully reversible

Remarks on result:

probability of weak irritation

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of weak irritation

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

8

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

two animals showed in the course of the study mild redness of the conjunctivae (score 1). No other signs of irritation were noted.

Other effects:

no other effects noted

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this test, Nomcort HK-P elicited mild, reversible, conjunctival initation to the eyes of rabbits. However the effects are not sufficient for meeting the classification criteria.

Executive summary:

Three (3) New Zealand white rabbits, free from visible ocular defects, each

received a single intraocular application of one-tenth of one milliliter (0.1 ml) of

the test article in one (1) eye. The contralateral eye, remaining untreated, served as

a control. The eyes of all animals remained unwashed for 24 hours. Observations

of corneal opacity, iritis, and conjunctivitis were recorded one (1), 24, 48, and 72

hours after treatment, and at four (4) and seven (7) days, if initation persisted. The

test article was uJed as a 20% suspension in distilled water, that had been heated at

approximately 70° C for 30 minutes. The mixture was allowed to cool prior to

dosing.

--------Average Draize Scores--------

Hours                                                  Days

1       24       48       72       4       7

Unwashed 2.0   0.7 0.7 0.7 0.0 -

Conclusion: Under the conditions of this test, this test article elicited mild, reversible,

conjunctival initation to the eyes of rabbits.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The presented information is conclusive but not sufficient for classification.