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EC number: - | CAS number: -
- 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
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- Auto flammability
- Flammability
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- 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
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
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- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
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- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
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- 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:
- November 20, 2012 - April 5, 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study has been performed in accordance with OECD 406 (1992), EU Method B.6 (2008), EPA OPPTS 870.2600 (2003) and according to GLP principles.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- (1992)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- (2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- (2003)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nohsan, Notification No. 8147, April 2011; including the most recent partial revisions
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The Maximization test was selected as preferred alternative since the Local Lymph Node Assay has shown to provide false positive results for surfactants.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: Young adult animals (approx. 5 weeks old) were selected
- Weight at study initiation: 287-353 g (for the 15 animals used in the main study)
- Housing: Group housing of maximally 5 animals per labeled Noryl cage
- Diet: Complete maintenance diet for guinea pigs (SSNIFF® Spezialdiäten GmbH, Soest, Germany); ad libitum
- Water: Free access to tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 24
- Humidity (%): 40 to 70
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 20 Nov 2012 To: 21 Dec 2012 - Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- See section "Details on study design"
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- See section "Details on study design"
- No. of animals per dose:
- Test animals: 10
Control animals: 5 - Details on study design:
- RANGE FINDING TESTS
- A total of 5 animals were used
- The animals were between 4 and 9 weeks old
- For the intradermal induction exposure:
Initially, a series of four test substance concentrations was used (0.1, 0.2, 0.5 and 1%). Each of two animals received two different concentrations in duplicate (0.1 mL/site) in the clipped scapular region. The resulting dermal reactions were assessed 24 and 48 hours after treatment. Based on the results in the initially treated animals, one additional animal was treated in a similar manner with two higher concentrations (2 and 5%) at a later stage. Both of these concentrations induced necrosis at the sites of injection.
- Result (intradermal induction): the 1% concentration showed to be minimal irritating and was used for the main test. Well-defined erythema after 24 hours and slight erythema after 48 hours was observed at this concentration.
- For the epicutaneous induction and challenge exposure (occlusive):
A series of four test substance concentrations was used (10, 20, 50 and undiluted, i.e., 100%). Two different concentrations were applied (0.5 mL each) per animal to the clipped flank, using Metalline patches# (2x3 cm) mounted on Medical tape# which were held in place with Micropore tape# and subsequently Coban elastic bandage#. The animals receiving intradermal injections (0.1, 0.2, 0.5 and 1%) were treated with the lowest concentrations and two further animals with the highest concentrations. After 24 hours, the dressing was removed and the skin cleaned of residual test substance using water. The treated skin areas were assessed for irritation 24 and 48 hours after exposure.
- Result (epidermal application): As no signs of erythema nor oedema were observed to the highest test substance concentration epidermally tested, 100% was chosen as the epidermal induction exposure and as the non-irritating challenge concentration, to use in the main test. One of the 2 animals applied with 100% did show scaliness (desquamation) at 24 hours after exposure. In accordance with the guidelines, the test site of all animals was treated with 10% SDS approximately 24 hours before the epidermal induction in the main study, to provoke a mild inflammatory reaction.
MAIN STUDY
Test animals: 10
Control animals: 5
A. INDUCTION EXPOSURE (test animals)
- No. of exposures: 2
1) Intradermal injections on day 1:
- Concentration: 1% in water
- Site: scapular region (clipped)
Three pairs of intradermal injections:
1) 0.1 mL: FCA (50% in water)
2) 0.1 mL: 1% of the substance in water
3) 0.1 mL: a 1:1 w/w mixture of the substance, at twice the concentration used in 2) and Freunds' Complete Adjuvant
- Readings: On day 3 the dermal reactions caused by the intradermal injections were assessed for irritation
On day 7, the scapular area between the injection sites was clipped and subsequently rubbed with 10% sodium-dodecyl-sulfate (SDS, Boom, Meppel, The Netherlands) in vaseline using a spatula. This concentration of SDS provokes a mild inflammatory reaction.
2)Topical application on day 8:
The 10% SDS treated area between the injection sites was treated with 0.5 mL of a 100% test substance concentration using a Metalline patch (2x3 cm) mounted on Medical tape, which was held in place with Micropore tape and subsequently Coban elastic bandage.
The dressing was removed after 48 hours exposure, the skin cleaned of residual test substance using water and the dermal reactions caused by the epidermal exposure were assessed for irritation (on day 10).
INDUCTION (control animals)
The control animals were treated as described for the experimental animals except that, instead of the test substance, vehicle alone was administered.
B. CHALLENGE EXPOSURE (all animals)
One flank of all animals was clipped and treated by epidermal application of a 100% test substance concentration and the vehicle (0.1 mL each), using Patch Test Plasters (Curatest®, Lohmann, Almere, The Netherlands). The patches were held in place with Micropore tape and subsequently Coban elastic bandage. The dressing was removed after 24 hours exposure and the skin cleaned of residual test substance and vehicle using water. The treated sites were assessed for challenge reactions 24 and 48 hours after removal of the dressing. - Positive control substance(s):
- yes
- Remarks:
- (a reliability check is carried out at regular intervals (<6 months) to check the sensitivity of the test system)
- Positive control results:
- The latest reliability check was carried out in May/June 2012 using Alpha-Hexylcinnamaldehyde. In this study, a sensitisation rate of 80% was found, showing that the test system is reliable.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 4.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 100%. No with. + reactions: 4.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The skin sensitization potential of the substance (a surfactant) was investigated using a GPMT study in accordance with OECD 406 (1992) and according to GLP principles. Based on the results of the study, the substance needs to be classified as a skin sensitiser in accordance with the CLP Regulation (sub-category 1B). The observed sensitization rate was 40%.
- Executive summary:
The skin sensitization potential of the substance (a surfactant) was investigated using a GPMT study in accordance with OECD 406 (1992), EU Method B.6 (2008), EPA OPPTS 870.2600 (2003) and according to GLP principles. The Maximization test was selected as preferred alternative since the Local Lymph Node Assay has shown to provide false positive results for surfactants.
Test substance concentrations selected for the main study were based on the results of a preliminary study. In the main study, ten experimental animals were intradermally injected with a 1% concentration with concurrent intradermal injections containing Freund’s Complete Adjuvant, then epidermally exposed to a 100% concentration. Five control animals were similarly treated, but with vehicle alone (water). Approximately 24 hours before the epidermal induction exposure all animals were treated with 10% SDS. Two weeks after the epidermal application all animals were challenged with a 100% test substance concentration and the vehicle.
Skin reactions of grade 1 accompanied by scaliness (desquamation) were observed in four experimental animals in response to the 100% test substance concentration. Scaliness was also noted for two other experimental animals. No skin reactions were evident in the control animals.
Skin reactions were observed in six (of the ten) experimental animals in response to a 1% intradermal induction dose and subsequent 100% epidermal induction and challenge dose, and consisted of slight erythema and scaliness in four (of the ten) experimental animals and scaliness only in two (of the ten) experimental animals. Scaliness observed as the sole skin reaction in two (of the ten) experimental animals was not considered to be clearly evident of sensitization, since this skin reaction was also noted in the prescreen test in response to the same test substance concentration applied epidermally to untreated animals. Therefore, a sensitization rate of 40 per cent was calculated.
Based on the results of the study, the substance needs to be classified as a skin sensitiser in accordance with the CLP Regulation (sub-category 1B).
Reference
READINGS (Main study)
Animal number |
Intradermal injection (Day 3) |
Epidermal exposure (Day 10) |
Challenge |
|||||||||
A |
B |
C |
D |
D |
Day 23 |
Day 24 |
||||||
Control |
E |
N |
E |
N |
E |
N |
Erythema |
Oedema |
100% |
Water |
100% |
Water |
51 |
3 |
|
0 |
|
2 |
|
0 |
0 |
0 |
0 |
0 |
0 |
52 |
3 |
|
1 |
|
2 |
|
0 |
0 |
0 |
0 |
0 |
0 |
53 |
3 |
|
0 |
|
3 |
|
0 |
0 |
0 |
0 |
0 |
0 |
54 |
3 |
|
0 |
|
3 |
|
0 |
0 |
0 |
0 |
0 |
0 |
55 |
3 |
|
0 |
|
2 |
|
1 |
0 |
0 |
0 |
0 |
0 |
Experimental |
||||||||||||
56 |
3 |
|
0 |
|
- |
2 |
1 |
0 |
1 |
0 |
1p |
0 |
57 |
3 |
|
0 |
|
3 |
- |
1 |
0 |
0 |
0 |
0p |
0 |
58 |
3 |
|
1 |
|
3 |
- |
2 |
0 |
1 |
0 |
1p |
0 |
59 |
3 |
|
1 |
|
- |
3 |
1 |
0 |
0 |
0 |
0 |
0 |
60 |
3 |
|
1 |
|
- |
2 |
1 |
0 |
0 |
0 |
0p |
0 |
61 |
3 |
|
1 |
|
- |
2 |
1 |
0 |
0 |
0 |
0 |
0 |
62 |
3 |
|
1 |
|
3 |
- |
3 |
0 |
0 |
0 |
0 |
0 |
63 |
3 |
|
1 |
|
3 |
- |
2 |
0 |
0 |
0 |
0 |
0 |
64 |
3 |
|
1 |
|
3 |
- |
1 |
0 |
1 |
0 |
1p |
0 |
65 |
3 |
|
1 |
|
3 |
- |
2 |
0 |
1 |
0 |
1p |
0 |
A: 1:1 Mixture of Freunds' Complete Adjuvant and water for injection.
B: A 1% test substance concentration (Experimental); vehicle (Control).
C: 1:1 Mixture of Freunds' Complete Adjuvant and a 2% concentration (Experimental) or vehicle (Control).
D: A 100% test substance concentration (Experimental); vehicle (Control).
E: Erythema (grade)
N: Signs of necrosis (mm in diameter)
p: Scaliness (desquamation)
Other information
- No mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study
- Body weights and body weight gain of experimental animals remained in the same range as controls over the study period
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Guinea pig maximisation test (OECD 406)
The skin sensitization potential of the substance (a surfactant) was investigated using a GPMT study in accordance with OECD 406 (1992), EU Method B.6 (2008), EPA OPPTS 870.2600 (2003) and according to GLP principles. The Maximization test was selected as preferred alternative since the Local Lymph Node Assay has shown to provide false positive results for surfactants.
Test substance concentrations selected for the main study were based on the results of a preliminary study. In the main study, ten experimental animals were intradermally injected with a 1% concentration with concurrent intradermal injections containing Freund’s Complete Adjuvant, then epidermally exposed to a 100% concentration. Five control animals were similarly treated, but with vehicle alone (water). Approximately 24 hours before the epidermal induction exposure all animals were treated with 10% SDS. Two weeks after the epidermal application all animals were challenged with a 100% test substance concentration and the vehicle.
Skin reactions of grade 1 accompanied by scaliness (desquamation) were observed in four experimental animals in response to the 100% test substance concentration. Scaliness was also noted for two other experimental animals. No skin reactions were evident in the control animals.
Skin reactions were observed in six (of the ten) experimental animals in response to a 1% intradermal induction dose and subsequent 100% epidermal induction and challenge dose, and consisted of slight erythema and scaliness in four (of the ten) experimental animals and scaliness only in two (of the ten) experimental animals. Scaliness observed as the sole skin reaction in two (of the ten) experimental animals was not considered to be clearly evident of sensitization, since this skin reaction was also noted in the prescreen test in response to the same test substance concentration applied epidermally to untreated animals. Therefore, a sensitization rate of 40 per cent was calculated.
Based on the results of the study, the substance needs to be classified as a skin sensitiser in accordance with the CLP Regulation (sub-category 1B).Other information (incl. HRIPT)
Despite a long history of use, observation of human skin sensitization is limited to one case report in the open literature. Absence of skin sensitization potential for humans is supported by data from a human RIPT. In this RIPT test, the material was diluted to a concentration of 10% w/v in distilled water prior to testing. During induction, the material was applied to the back three times per week for three successive weeks. Sites were covered for 24 h with non-occlusive patches secured with surgical tape. Repeated applications were made to the same test sites. Reactions were scored 48 or 72 h after each induction application according to the Draize scale. The challenge phase was initiated 10 to 15 days after application of the final induction patch. Challenge patches (non-occlusive) were applied for 24 h to new sites on the back; reactions were scored 48 and 96 h later. It was reported that it did not induce skin irritation or sensitization in any of the subjects tested.
LLNA study with a marketed formulation
With a marketed formulation containing the registered substance at 8.2% a LLNA study has been performed in accordance with OECD 429 (2002), EU Method B.42 (2004) and EPA OPPTS 870.2600 (2003). Proper conduct of the LLNA was confirmed via a positive response using 30% α-hexylcinnamaldehyde (HCA), a moderate contact sensitizer, which elicited proliferation that was 9.6 in comparison to vehicle-treated mice. As the formulation elicited proliferative responses with stimulation indices (SI) below 3 at all test concentrations (including undiluted formulation) in comparison to vehicle-treated mice, the formulation did not demonstrate potential to induce dermal sensitization in the mouse LLNA. The results therefore support the conclusion that the registered substance at a concentration of 8.2% or below does not induce skin sensitization.
Migrated from Short description of key information:
The skin sensitization potential of the substance (a surfactant) was investigated using a GPMT study in accordance with OECD 406 (1992) and according to GLP principles. Based on the results of the study, the substance needs to be classified as a skin sensitizer in accordance with the CLP Regulation (sub-category 1B). Despite a long history of use, observation of human skin sensitization is limited to one case report in the open literature. Absence of skin sensitization potential for humans is supported by data from a human RIPT with 10%. Furthermore, in a LLNA assay, a formulation containing the registered substance at 8.2% did not induce sensitization.
Justification for selection of skin sensitisation endpoint:
Key study conducted in compliance with OECD guideline and GLP.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the results of the GPMT study, the substance needs to be classified as a skin sensitiser in accordance with the CLP Regulation (sub-category 1B).
At a concentration of 8.2% or below, the substance does not induce skin sensitization, based on the results of the LLNA study with a formulation. This is also supported by the absence of sensitization reactions in a human RIPT study at 10%.
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