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EC number: 701-350-3 | 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
- 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
No evidence of skin sensitisation was observed in a Buehler Test conducted in guinea pigs according to OECD Test Guideline 406.
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:
- 6th November - 12th November 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- A Buehler study was conducted for research and development purposes. However, in the interest of promotong the 3R principle it would be unethical to run another in vivo study to the LLNA method.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- Prior to use, all animals were acclimated for at least five days. Animals were individually housed
in wire mesh suspension cages. The animals were maintained on a 12-hour cycle light controlled
room, at a temperature of 64° - 79°F and a relative humidity of 30-70%. - Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.4 mL at a 20% concentration
- Day(s)/duration:
- six hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 5%
- Day(s)/duration:
- 14
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20 animals in test group,
6 control animals - Details on study design:
- 0.4 ml of the test substance at a 20% concentration diluted in mineral oil directly into Hilltop Chambers® and applying
them to the clipped left shoulder of twenty albino guinea pigs in the following manner: The
animals were held gently, and the chambers were applied as quickly as possible to the clipped left
shoulder. The chambers were secured with Micropore tape and further secured with Kendall
adhesive tape. Approximately six hours later, the tape and chambers were removed. Two
additional induction doses were conducted following the same procedure, at weekly intervals.
Two weeks after the final application the animals received a topical primary challenge dose (6
hour contact) of X-16151, Batch #: R17-2934 at 5% concentration diluted in mineral oil, on a naive
site located on the right shoulder. Animals were scored for irritation at 24 and 48 hours after
initiation of the primary challenge application.
Ten guinea pigs served as a naive control group, and remained untreated through the induction
phase. Six naive control animals received only the primary challenge dose, at a 5% concentration
diluted in mineral oil. The four remaining guinea pigs were designated for a re-challenge, if
necessary. - Positive control substance(s):
- no
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test susbtance did not induce skin sensitization
- Executive summary:
The test substance was evaluated for sensitization potential by applying 0.4 ml at a 20% concentration diluted in mineral oil directly into Hilltop Chambers® and applying them to the clipped left shoulder of twenty albino guinea pigs in the following manner: The animals were held gently, and the chambers were applied as quickly as possible to the clipped left
shoulder. The chambers were secured with Micropore tape and further secured with Kendall adhesive tape. Approximately six hours later, the tape and chambers were removed. Two additional induction doses were conducted following the same procedure, at weekly intervals.
Two weeks after the final application the animals received a topical primary challenge dose (6 hour contact) of the test substance at 5% concentration diluted in mineral oil, on a naive site located on the right shoulder. Animals were scored for irritation at 24 and 48 hours after initiation of the primary challenge application.
Ten guinea pigs served as a naive control group, and remained untreated through the induction phase. Six naive control animals received only the primary challenge dose, at a 5% concentration diluted in mineral oil. The four remaining guinea pigs were designated for a re-challenge, if necessary.
Following primary challenge of test substance at 5% concentration, the incidence of grade 1 response or greater in the test group (0 of 20) was compared to that of the naive control group (0 of 6). The incidence and severity of these responses were not significantly greater than those produced by the naive control group indicating that sensitization had not been induced.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The test substance was evaluated for sensitization potential by applying 0.4 ml at a 20% concentration diluted in mineral oil directly into Hilltop Chambers® and applying them to the clipped left shoulder of twenty albino guinea pigs in the following manner: The animals were held gently, and the chambers were applied as quickly as possible to the clipped left
shoulder. The chambers were secured with Micropore tape and further secured with Kendall adhesive tape. Approximately six hours later, the tape and chambers were removed. Two additional induction doses were conducted following the same procedure, at weekly intervals.
Two weeks after the final application the animals received a topical primary challenge dose (6 hour contact) of the test substance at 5% concentration diluted in mineral oil, on a naive site located on the right shoulder. Animals were scored for irritation at 24 and 48 hours after initiation of the primary challenge application.
Ten guinea pigs served as a naive control group, and remained untreated through the induction phase. Six naive control animals received only the primary challenge dose, at a 5% concentration diluted in mineral oil. The four remaining guinea pigs were designated for a re-challenge, if necessary.
Following primary challenge of test substance at 5% concentration, the incidence of grade 1 response or greater in the test group (0 of 20) was compared to that of the naive control group (0 of 6). The incidence and severity of these responses were not significantly greater than those produced by the naive control group indicating that sensitization had not been induced.
The study was assessed as Klimisch 1, as it is compliant with GLP and OECD Test Guidelines. It is therefore considered to be sufficiently reliable for classification purposes. In vitro skin sensitisation studies are not available; these do not need to be conducted since adequate data are already available from an in vivo skin sensitisation study.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
No data are available on respiratory sensitisation. However, exposure of humans via inhalation is considered unlikely.
Justification for classification or non-classification
Based on the available data, the substance is not classified for skin sensitisation in accordance with Regulation (EC) No. 1272/2008. No data are available on respiratory sensitisation.
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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