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

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

31. May - 24. July 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

GLP compliance:

no

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

Test conducted before adoption of LLNA Guidelines

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

478-920-0

EC Name:

-

Cas Number:

457632-32-5

Molecular formula:

C22H44O2.4 C20H38O4.1 (C3H8O3).20

IUPAC Name:

1,20-bis({3-[3-(2,3-dihydroxypropoxy)-2-hydroxypropoxy]-2-hydroxypropyl}) icosanedioate

Test material form:

solid: pellets

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 applicable

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 stated
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not stated


TREATMENT OF TEST MATERIAL PRIOR TO TESTING
not stated

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: not stated
- Females (if applicable) nulliparous and non-pregnant: not specified
- Microbiological status of animals, when known: SPF, not further specified
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 425 - 465 (test group)
- Housing: not state d
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
- Indication of any skin lesions: checked at acclimation start, none reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 60 ° - 80° F
- Humidity (%): 30 - 70
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: To:

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal and epicutaneous

Vehicle:

water

Concentration / amount:

20 % stock solution for intradermal injection and topical application

Day(s)/duration:

48 h topical application

Adequacy of induction:

non-irritant substance, but skin pre-treated with 10% SDS

Challenge

No.:

#1

Route:

epicutaneous, semiocclusive

Vehicle:

water

Concentration / amount:

20 % stocksolution, at 50 % in distilled water, 0.4 mL

Day(s)/duration:

24 hours

Adequacy of challenge:

highest non-irritant concentration

No. of animals per dose:

5

Details on study design:

Two (2) weeks after the topical induction applications, the challenge applications were made.
Prior to dosing, a five by five (5 x 5) cm area of the flank of each guinea pig, in the test groups
for the test and positive control aiticle, as well as the negative control groups for each article, was
shaved as detailed previously. The test or positive control articles, at the screen detennined
highest non-irritating concentrations, were applied to the flanks of the appropriate animals.
Four-tenths (0.4) of a milliliter of each article was applied to each site via a 25 mm Hilltop
Chamber (with the cotton patch). The animals were wrapped after dosing, with a piece of three
(3) inch Elastoplast® elastic tape, that had been lined on the adhesive side with a three (3) inch
wide strip of Pure Latex Dental Dam. The wraps remained in place for 24 hours. Twenty-one
hours after unwrapping, any remaining article was removed with an ethanol wipe and the test site
was shaved if necessary. Three hours later, the test site was scored according to the attached
Draize Scale (Table 1). Twenty-four and 48 hours later, the sites were again scored.
Two (2) indices were calculated from the erythema scores for each article, one (1) to evaluate the
incidence of erythema (reaction) and the other to evaluate the severity of erythema. The indices
for incidence and severity were calculated for the control groups and for the induction groups
from the erythema responses observed at the 48, 72 and 96 hour post-challenge examinations.
The incidence index was calculated by counting the number of animals showing an erythema
response [one (1) or greater] for a specified time period and dividing by the number of test sites
(animals) examined at the time period (# responses/# per group). The seve1ity index was
calculated by adding the erythema scores [one (1) or greater] for a specified time period and
dividing by the number of scores added (sum of erythema scores/# scores added). The two (2)
indices were used to evaluate the sensitization potentials of the articles. The edema scores were
noted but were not used in the calculation of any indices.


Initial and terminal body weights were recorded for the non-screen animals. Sacrificing was
accomplished via carbon dioxide asphyxiation. All animals appeared healthy throughout the
study.

Challenge controls:

20 % test article stock solution of 20 % in distilled water, at 50 %

Positive control substance(s):

yes

Results and discussion

Positive control results:

the positive control substance resulted in effects characteristic for skin sensitzers.

In vivo (non-LLNA)

Results

Results 1

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

20 %

No. with + reactions:

0

Total no. in group:

5

Clinical observations:

all animals appeard healthy throughout the study

Remarks on result:

no indication of skin sensitisation

Results 2

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

positive control

Dose level:

0.05%

No. with + reactions:

5

Total no. in group:

5

Clinical observations:

all animals appeard healthy throughout the study

Remarks on result:

positive indication of skin sensitisation

Results 3

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

0 %

No. with + reactions:

0

Total no. in group:

5

Clinical observations:

all animals appeard healthy throughout the study

Remarks on result:

no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Executive summary:

Five (3M:2F) Hartley-strain albino, outbred, viral antibody free, guinea pigs (SPF

Ha1tley guinea pig Aai: (HA) Outbred), 425 - 465 grams, were utilized as the test

group. An additional five (2M:3F) Hartley-strain guinea pigs, 378 - 450 grams,

were utilized as the control group. For induction, each animal in the test group

received three (3) pairs of intradennal injections, with and without the test a1ticle.

Dming the second week of the induction phase, topical applications of the test

article were made to the induction site of each animal in the test group. Two (2)

weeks after the topical induction applications, the challenge applications were

made. These 24 hour challenge applications were made to virgin sites on the

flank of each animal in the test and control groups, at the screen detennined,

highest non-irritating concentration of 10% in distilled water. Observations of

erythema, edema and other effects were recorded 48, 72 and 96 hours after the

challenge applications. The test article was prepared as a 20% suspension (stock

solution) in distilled water, that had been heated at approximately 70° C for 30

minutes. The mixture was allowed to cool prior to use.

Results:

Index:	Incidence	Severity
Group	Test/Control	Test/Control
Scoring Interval:	0/0	0/0
48 Hours:	0/0	0/0
72 Hours:	0/0	0/0
96 Hours:	0/0	0/0