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EC number: 273-620-4 | CAS number: 68990-67-0 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Quillaja saponaria, Rosaceae.
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- 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 chemical
- 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 chemical
- 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.
- 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.
Reference
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 |
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..
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