Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2005-07-07 - 2005-09-06
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Data obtained from a guideline study according to OECD guideline 105 and therefore considered reliable without restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
gas under pressure: refrigerated liquefied gas
Details on test material:
Test substance name according to the label: Quillaja Liquid Agri QL Agri 35-15
Batch No.: 280704
Solid content: 35.3° ±0.4 Brix (aprox. 30% w/w solid)
Triterpenic saponines : > 6% w/w determined by HPLC
Appearance: Caramel colour liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
Test system: Guinea Pig (Cavia porcellus), Hartley.
Source: Distribuidora Izaguirre. Antonia Ribero 2352 - 1708 Moron - Pcia. de Buenos Aires. Argentina.
Number and gender of the test animals: 33 animals (15 males and 18 females)
Age and weight at the start of the test: Young adult animals, 5-7 weeks and 300-400 g. body weight.
Identification: By cage number and ear labels. Selection: Animals were chosen at random at the time of the assay.
Acclimatization: 11 days under the test conditions after the clinical exam.
Housing and feeding: Animals were housed individually under standard laboratory conditions, in cages made of steel with litter of wood shavings.
Animals were fed maintenance food supplied by Distribuidora Horacio Izaguirre and tap water (dechlorinated by passage through cartridge of activated charcoal) ad libitum. The diet was enriched daily with fresh vegetables.
The animals' test facility was provided with conditioned air by HEPA filters, with 10 to 15 air changes per hour. The temperature of the animals' room was 22 ± 3°C and the relative humidity 30-70 per cent, although the upper relative humidity range may have been exceeded during cleaning of the room.
Animals were provided with photoperiods of 12 hours light and 12 hours darkness.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Induction: 100% w/v
Challange: 100% w/v
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Induction: 100% w/v
Challange: 100% w/v
No. of animals per dose:
Control group: 10 animals
Test group: 20 animals
Details on study design:
INDUCTION APPLICATION
Topical applications:

Day 0
Treated group: Both flanks were cleared of hair, a filter paper (2x4 cm) loaded with 0.5 ml of solution sample was applied on the shaved area of the left flank and held in contact with the skin for 6 hours, by an hypoallergenic adhesive bandage. The test substance was removed of the animal's skin with humid gauze in distilled water.
Control Group: No applications were performed.

Day 7
Treated group: A filter paper (2x4 cm) loaded with 0.5 ml of solution sample was applied on the shaved area of the left flank and held in contact for 6 hours, by a hypoallergenic bandage.
Control Group: No applications were performed.

Day 14
Treated group: A filter paper (2x4 cm) loaded with 0.5 ml of solution sample was applied on the shaved area of the left flank and held in contact for 6 hours, by an hypoallergenic adhesive bandage.
Control Group: No applications were performed.

CHALLENGE APPLICATION
Day 28
Treated group: The filter paper loaded with 0.5 ml of solution sample was applied on the right flank. Patches were held in contact with the skin for 6 hours, by a hypoallergenic adhesive bandage.
Control Group: The filter paper loaded with 0.5 ml of solution sample was applied on the right flank. Patches were held in contact with the skin for 6 hours, by a hypoallergenic adhesive bandage.

Mortality and behaviour: Animals were observed daily, from the start of the pre-test to the fmalization of the test. No evidence of systemic toxic effects was observed and there were no deaths.
The body weight and body weight gain both of treated and control animals were within the normal biological range of the strain and age of guinea pigs used. Skin reactions: were assessed during the evaluation of the reaction at induction and challenge
Positive control substance(s):
yes
Remarks:
Benzocaine (Cas No. 94-09-7)

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100% w/v
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100% w/v. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100% w/v
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100% w/v. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.

Any other information on results incl. tables

CHALLENGE TEST FOR POSITIVE CONTROL: Benzocaine (Cas No. 94-09-7)

Challenge Application

 

Right flank

Animal N°

24hours

48 hours

 

Erythema Grade

Erythema Grade

4

1

0

5

0

0

6

0

0

7

1

0

8

1

0

9

0

0

10

0

0

11

0

0

12

0

0

13

1

0

14

0

0

15

1

0

16

1

0

17

0

0

18

0

0

19

0

0

20

1

0

Affected animals (%)

40

0

CHALLENGETEST FORTHE CONTROL GROUP

Challenge Application

 

Right flank

Animal N°

24 hours

48 hours

 

Erythema Grade

Erythema Grade

24

0

0

25

0

0

26

0

0

27

0

0

28

0

0

29

0

0

30

0

0

31

0

0

32

0

0

33

0

0

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The aim of the sensitization study was to assess the allergenic potential of Quillaja Liquid Agri QL Agri 35-15 according to the test method described by EV Buehler, (OECD 406).
Following dose levels were used: 100% w/v solution of Quillaja Liquid Agri QL Agri 35-15 in the the induction phase, 100% w/v solution of Quillaja Liquid Agri QL Agri 35-15 in the challenge phase.
Quillaja Liquid Agri QL Agri 35-15 didn't cause skin sensitization on the Guinea pigs skin. Animals behaved normally and their external appearance was not influenced by the treatment.
Executive summary:

The aim of the sensitization study was to assess the allergenic potential of Quillaja Liquid Agri QL Agri 35-15 according to the test method described by EV Buehler, (OECD 406).

Following dose levels were used: 100% w/v solution of Quillaja Liquid Agri QL Agri 35-15 in the the induction phase, 100% w/v solution of Quillaja Liquid Agri QL Agri 35-15 in the challenge phase.

Quillaja Liquid Agri QL Agri 35-15 didn't cause skin sensitization on the Guinea pigs skin. Animals behaved normally and their external appearance was not influenced by the treatment.