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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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.
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
Buehler test
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.
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Induction: 100% w/v
Challange: 100% w/v
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)
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.

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

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

No data gaps were identified. The available data are adequate for risk assessment and classification and labelling purposes.


Migrated from Short description of key information:
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.

Justification for selection of skin sensitisation endpoint:
One reliable study is available.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In an OECD Guideline 406 study (Skin Sensitisation: Bühler Test), no signs of skin sensitisation were observed.

According to the CLP Regulation (EU GHS Regulation (EC) No 1272/2008) no classification and labelling is required for skin sensitisation of Quillaja saponaria ext..