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EC number: 701-118-1 | CAS number: 2156592-54-8
- 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:
- 2012-07-09 to 2012-10-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The registration substance is a surfactant. The LLNA is not an approriate test system for surfactants according to the guideline.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- - Semi barrier in an air-conditioned room
- Temperature: 22 +/- 3 °C
- Relative humidity: 55 +/- 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: at least 10 x / hour
- Free access to autoclaved hay and to Altromin 3122 maintenance diet for guinea pigs (lot no. 1725), rich in crude fibre
- Free access to tap water (drinking water, municipal residue control, microbiological controls at regular intervals)
- The animals were kept in groups in Terluran - cages on Altromin saw fibre bedding (lot no. 300312)
- Certificates of food, water and bedding are filed at BSL BIOSERVICE
- Adequate acclimatisation period (at least five days) under laboratory conditions - Route:
- intradermal and epicutaneous
- Vehicle:
- other: cottonseed oil
- Concentration / amount:
- For the intradermal injection (induction - first stage), 0.125 g of the test item were dissolved in cottonseed oil to gain a final volume of
10 mL of a 1.25% solution (w/v).
For the topical application (induction – second stage), 0.5 g of the test item were applied directly at a 100% concentration.
For the topical application (challenge), 0.5 g of the test item were applied directly at a 100% concentration. - Route:
- epicutaneous, occlusive
- Vehicle:
- other: cottonseed oil
- Concentration / amount:
- For the intradermal injection (induction - first stage), 0.125 g of the test item were dissolved in cottonseed oil to gain a final volume of
10 mL of a 1.25% solution (w/v).
For the topical application (induction – second stage), 0.5 g of the test item were applied directly at a 100% concentration.
For the topical application (challenge), 0.5 g of the test item were applied directly at a 100% concentration. - No. of animals per dose:
- 10 test animals and 5 control animals and 4 for the preliminary test
- Details on study design:
- Induction: First Stage, Intradermal Injection
Three pairs of intradermal injections of 0.1 mL volume were given in the shoulder region which was cleared of hair by clipping so that one of each pairlies on each side of the midline.
Test Group: Day 0
Injection 1: a 1:1 mixture (v/v) FCA/physiological saline 0.9% NaCl
Injection 2: a 1.25% concentration of the test item in cottonseed oil
Injection 3: a 1.25% concentration of the test item in cottonseed oil formulated in a 1:1 mixture (v/v) FCA/physiological saline 0.9% NaCl
Control Group: Day 0
Injection 1: a 1:1 mixture (v/v) FCA/physiological saline 0.9% NaCl
Injection 2: 100% cottonseed oil
Injection 3: a 50% (v/v) formulation of cottonseed oil in a 1:1 mixture (v/v) FCA/physiological saline 0.9% NaCl
Injections 1 and 2 were given close to each other and nearest to the head, while injection 3 was given toward the caudal part of the test area.
Induction: Second Stage, Topical Application
Test Group and Control Group: Day 6
Approximately twenty-four hours before the topical application the test area was painted with 0.5 g of 10% sodium lauryl sulphate in vaseline
after close clipping in order to create a local irritation.
Test Group: Day 7
The test item was applied at a concentration of 100%. A patch was fully loaded with 0.5 g of the test item. Then it was applied to the test area and held in contact with the help of an occlusive dressing for 48 hours.
Control Group: Day 7
A patch was fully loaded with 0.5 g of vaseline. Then it was applied to the test area and held in contact with the help of an occlusive dressing
for 48 hours. - Challenge controls:
- Challenge: Topical Application
The flanks of treated and control animals were cleared of hair by close-clipping.
Test Group and Control Group: Day 20
The test item was applied at a concentration of 100%. A patch, loaded with 0.5 g of the prepared test item was applied to the left flank of the animals
and a patch loaded with 0.5 g of the vehicle to the right flank (intraspecific control). The patches were held in contact with the help
of an occlusive dressing for 24 hours.
The application area was not rinsed.
Observation
Test Group and Control Group
Approximately 21 hours after removing the patch, the challenge area was cleared of hair by the use of a depilatory cream. Approximately 24 and 48 hours after removing the patch the skin reaction was observed and recorded according to the grades shown below.
Additionally all animals were observed for signs of toxicity at least once daily during the test period. - Positive control substance(s):
- not required
- Remarks:
- performed periodically every 6 months
- Positive control results:
- The recent reliability check was performed in March/April 2012. The raw data of this study are kept in the BSL archives (BSL Project ID 120793).
The reliability checks are audited by the QA-unit periodically.
Positive-control substance: mercaptobenzothiazole, purity > 98%,
Fluka Chemica, Lot No. 41107195, expiry date: 20/01/2014
Concentrations: 2% induction I phase
25% induction II phase
15% challenge
The sensitisation rate after application of the positive-control substance mercaptobenzothiazole (15% in vaseline) was 100%, confirming
the reliability of the test system. - Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1.25% intradermal, 100% dermal, 100% challenge
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1.25% intradermal, 100% dermal, 100% challenge
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100% challenge
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100% challenge
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- The registration substance was investigated for its skin sensitization potential according to the OECD Guideline 406.
The registration substance is a non skin sensitizer. - Executive summary:
The registration substance was investigated for its skin sensitization potential according to the OECD Guideline 406.
The registration substance is a non skin sensitizer.
Reference
Preliminary Test
1 animal was treated intradermally with concentrations of 5% and 2.5% of the test item (dissolved in cottonseed oil, Sigma-Aldrich, lot no. MKBJ0602V, expiry date: 09/2012).
1 animal was treated intradermally with concentrations of 1.25% and 0.75% of the test item (dissolved in cottonseed oil, Sigma-Aldrich, lot no. MKBJ0602V, expiry date: 09/2012).
1 animal was treated topically with concentrations of 100% and 50% of the test item (suspended in vaseline (Euro OTC Pharma, lot no. 1009040-01, expiry date: 09/2013)for 24 hours.
1 animal was treated topically with concentrations of 100% and 50% of the test item (suspended in vaseline (Euro OTC Pharma, lot no. 1009040-01, expiry date: 09/2013)for 48 hours.
Based on the results of this preliminary test, a concentration of 1.25% was chosen for the intradermal application of the main test and a concentration of 100% was selected for the dermal induction. These concentrations caused slight signs of irritation, without leading to systemic effects.
A concentration of 100% was found to be the highest dose which did not cause any signs of irritation after a topical treatment over a period of 24 hours and therefore was chosen for the challenge application in the main test.
Main Test
Signs of irritation during the induction:
Intradermal Induction I (24-hour reading):
Injection site 1: erythema
grade 1 in 5/5 control and 10/10 test animals,
oedema grade 1 in 5/5 control and 10/10 test animals
Injection site 2: erythema grade 1 and oedema grade 1 in 10/10 test animals
Injection site 3: erythema
grade 1 in 5/5 control and 10/10 test animals,
oedema grade 1 in 5/5 control and 10/10 test animals
Intradermal Induction I (48-hour reading):
Injection site 1: erythema
grade 1 in 5/5 control and 10/10 test animals,
oedema grade 1 in 5/5 control and 10/10 test animals
Injection site 2: erythema grade 1 and oedema grade 1 in 10/10 test animals
Injection site 3: erythema
grade 1 in 5/5 control and 10/10 test animals,
oedema grade 1 in 5/5 control and 10/10 test animals
Dermal Induction II (48-hour exposure, occlusive):
Immediately after removing the patch: no signs of irritation in any of the test or control animals.
24 hours after removing the patch: no signs of irritation in any of the test or control animals.
Challenge Exposure (24-hour exposure, occlusive):
Neither erythema nor oedema was observed in any animal at any time of observation.
There was no evidence of sensitisation and the percentage of sensitised animals was 0%.
Table: Challenge Exposure
Challenge Concentrations of Test Substance: 100% |
||
|
Number of Animals Showing Skin Reactions after |
|
24 hours |
48 hours |
|
Test Group |
0 |
0 |
Negative-Control Group |
0 |
0 |
Body Weight Development
The body weight development was within the biological range for all animals compared to historical data.
All animals of both groups survived throughout the test period.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The registration substance was investigated for its skin sensitization potential according to the OECD Guideline 406. The registration substance is a non skin sensitizer.
Migrated from Short description of key information:
The registration substance is a non-sensitizer.
Justification for selection of skin sensitisation endpoint:
Guideline study; well-performed and well documented.
Justification for classification or non-classification
The registration substance was investigated for its skin sensitization potential according to the OECD Guideline 406. The registration substance is a non skin sensitizer. No classification is warranted.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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