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EC number: 701-394-3 | CAS number: 1782069-81-1
- 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
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Endpoint summary
Administrative data
Description of key information
No indications of a positive skin sensitisation result were observed in the Buehler test with the test item in male and female guinea pigs.
No information on respiratory sensitisation is available.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- Bühler test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not applicable
- Principles of method if other than guideline:
- - Principle of test: Male and female guinea pigs were exposed to the test item (at the intended maximum concentration) and a vehicle control for 5 days (Monday through Friday) for 2 consecutive weeks (total of 10 treatments), a positive control for 5 days (Monday through Friday) for 1 week, and an untreated control. The induction period was followed by a 2 week observation period. After the observation period, a challenge test was performed with 1/10 of the induction dose for the test item and positive control groups. Previously untreated animals were also challenge tested in the same manner as the test item, vehicle control and positive control groups.
- Short description of test conditions: Experimental conditions were maintained at 23 to 33 °C with 45 to 73% relative humidity.
- Parameters analysed / observed: Systemic intoxiction symptoms, body weight, mortality, local changes - GLP compliance:
- no
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The REACH Annex VII information requirements were revised in 2016 to endorse a battery of in vitro assays for skin sensitisation. Conducted prior to the validation and regulatory acceptance of alternative methods, the reliable and GLP compliant in vivo Buehler test was considered sufficient to fulfil the information requirement.
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Remarks:
- White-EMD
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 215 to 430 g (mean 333 g)
- Housing: Individually caged in Makrolon cages Type III.
- Diet: Altromin MS, ad libitum.
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 to 33 °C
- Humidity (%): 45 to 73 % - Route:
- epicutaneous, open
- Vehicle:
- peanut oil
- Remarks:
- DAB 7
- Concentration / amount:
- 3 g test item + 100 mL vehicle
- Day(s)/duration:
- 5 times per week (Monday through Friday) for 2 consecutive weeks, total of 10 times
- Adequacy of induction:
- other: intended maximum concentration
- Route:
- epicutaneous, open
- Vehicle:
- other: ether
- Concentration / amount:
- 2% dinitrochlorobenzene
- Day(s)/duration:
- 5 days (Monday through Friday)
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, open
- Vehicle:
- peanut oil
- Remarks:
- DAB 7
- Day(s)/duration:
- 5 times per week (Monday through Friday) for 2 consecutive weeks, total of 10 times
- Adequacy of induction:
- other: vehicle control
- Route:
- other: no treatment
- Vehicle:
- unchanged (no vehicle)
- Adequacy of induction:
- other: untreated control
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- peanut oil
- Remarks:
- DAB 7
- Concentration / amount:
- 0.3 g test item + 100 mL vehicle
- Day(s)/duration:
- Single application
- Adequacy of challenge:
- other: 1/10 of the previously used concentration
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- other: ether
- Concentration / amount:
- 0.2% dinitrochlorobenzene
- Day(s)/duration:
- Single application
- Adequacy of challenge:
- other: 1/10 of the previously used concentration
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- peanut oil
- Remarks:
- DAB 7
- Day(s)/duration:
- Single application
- Adequacy of challenge:
- other: vehicle control
- No.:
- #2
- Route:
- epicutaneous, open
- Vehicle:
- peanut oil
- Remarks:
- DAB 7
- Concentration / amount:
- 0.3 g test item + 100 mL vehicle
- Day(s)/duration:
- Single application
- Adequacy of challenge:
- other: 1/10 of the previously used concentration, applied on previously untreated animals
- No.:
- #2
- Route:
- epicutaneous, open
- Vehicle:
- other: ether
- Concentration / amount:
- 0.2% dinitrochlorobenzene
- Day(s)/duration:
- Single application
- Adequacy of challenge:
- other: 1/10 of the previously used concentration, applied on previously untreated animals
- No.:
- #2
- Route:
- epicutaneous, open
- Vehicle:
- peanut oil
- Remarks:
- DAB 7
- Day(s)/duration:
- Single application
- Adequacy of challenge:
- other: applied on previously untreated animals
- No. of animals per dose:
- 5 males and 5 females per treatment, positive control and vehicle control.
7 males and 8 females for the untreated control. - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10 for test item and vehicle control, 5 for positive control.
- Exposure period: 2 weeks for test item and vehicle control, 1 week for positive control.
- Test groups: Test item and positive control.
- Control group: Vehicle control and untreated control.
- Site: Left flank.
- Frequency of applications: 5 times per week (Monday through Friday) for 2 consecutive weeks for test item and vehicle control, 5 times per week (Monday through Friday) for 1 week for positive control.
- Duration: Induction exposure was followed by 2 weeks of no treatment for the test item and vehicle control and 1 week of no treatment for the positive control.
- Concentrations: 3 g test item + 100 mL vehicle
B. CHALLENGE EXPOSURE
- No. of exposures: Single application.
- Day(s) of challenge: 1 day.
- Exposure period: 1 day.
- Test groups: Test item and positive control.
- Control group: Vehicle control and untreated control.
- Site: Right flank (previously untreated).
- Concentrations: 0.3 g test item + 100 mL vehicle
- Evaluation (hr after challenge): 3 hours
OTHER: Prior to the first treatment, the animals were shaved at the left flank. Shaving was repeated twice (Monday and Thursday) during the treatment period. The animals were weighed twice per week (Monday and Thursday) after the start of the trial for 2 weeks, including the following Monday. - Challenge controls:
- Vehicle control
- Positive control substance(s):
- yes
- Remarks:
- dinitrochlorobenzene (2% solution in ether)
- Positive control results:
- Marked erythema was observed after three treatments of the positive control group, which persisted throughout the remaining induction period. The symptoms disappeared after the first day of the observation period. A distinctly circumscribed, very marked erythema developed about 3 hours after the challenge application at the treated skin site in all animals. Previously untreated animals tolerated the challenge application with the positive control (at 1/10 of the induction dose) without irritation and reaction.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 3
- Group:
- test chemical
- Dose level:
- 0.3 g test item + 100 mL peanut oil DAB 7
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 3
- Group:
- negative control
- Dose level:
- peanut oil DAB 7
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 3
- Group:
- positive control
- Dose level:
- 0.2% dinitrochlorobenzene
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- distinctly circumbscribed, very marked erythema
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 3
- Group:
- other: test group (previously untreated)
- Dose level:
- 0.3 g test item + 100 mL peanut oil DAB 7
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 3
- Group:
- other: negative control (previously untreated)
- Dose level:
- peanut oil DAB 7
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 3
- Group:
- other: positive control (previously untreated)
- Dose level:
- 0.2% dinitrochlorobenzene
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No differences in local changes during the induction, observation period or challenge test were observed in animals treated with the test item.
- Executive summary:
Skin sensitisation of the test item was tested in male and female Pirbright-White-EMD guinea pigs using a Buehler test. Guinea pigs were exposed to the test item (3 g test item in 100 mL peanut oil DAB 7, intended maximum concentration) and a vehicle control (peanut oil DAB 7) for 5 days (Monday through Friday) for 2 consecutive weeks (total of 10 treatments), a positive control (2% dinitrochlorobenzene in ether) for 5 days (Monday through Friday) for 1 week, and an untreated control. The induction period was followed by a 2 week observation period. After the observation period, a challenge test was performed with 1/10 of the induction dose for the test item and positive control groups. Previously untreated animals were also challenge tested in the same manner as the test item, vehicle control and positive control groups. Mortality and clinical abnormalities were not observed during the treatment and observation times. All animals gained considerable weight. No differences in local changes during the induction and observation period were observed between the test item treatment and vehicle control animals. No reaction was observed in the test item or vehicle control after the challenge application. Previously untreated animals tolerated the challenge application with the test item and positive control (at 1/10 of the induction dose) and vehicle without irritation and reaction. In the positive control, marked erythema was observed after three treatments, which persisted throughout the remaining induction period. The symptoms disappeared after the first day of the observation period. A distinctly circumscribed, very marked erythema developed about 3 hours after the challenge application at the treated skin site in all animals. This study is considered to be reliable with restriction (Klimisch 2) as it was conducted similar to OECD Guideline 406, however there were minor limitations in experimental design and reporting.
Reference
Mortality and clinical abnormalities were not observed during the treatment and observation times. All animals gained considerable weight. No differences in local changes during the induction and observation period were observed between the test item treatment and vehicle control animals. No reaction was observed in the test item or vehicle control after the challenge application. Previously untreated animals tolerated the challenge application with the test item (at 1/10 of the induction dose) and vehicle without irritation and reaction.
Table 1. Body weight
Group | Sex | Mean body weight (g) | Difference of final weight from starting weight (g) | ||||
|
|
Day 0 |
Day 3 |
Day 7 |
Day 10 |
Day 14 |
|
Test item | Male | 372 | 397 | 429 | 457 | 486 | +144 |
Test item | Female | 330 | 341 | 360 | 376 | 402 | +72 |
Positive control | Male | 255 | 298 | 326 | 361 | 398 | +143 |
Positive control | Female | 249 | 280 | 319 | 337 | 371 | +122 |
Vehicle control | Male | 401 | 434 | 471 | 508 | 547 | +146 |
Vehicle control | Female | 324 | 349 | 385 | 406 | 438 | +144 |
Untreated control | Male | 344 | 383 | 424 | 445 | 466 | +122 |
Untreated control | Female | 416 | 448 | 480 | 506 | 526 | +110 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitisation of the test item was tested in male and female Pirbright-White-EMD guinea pigs using a Buehler test (1973). Guinea pigs were exposed to the test item (3 g test item in 100 mL peanut oil DAB 7, intended maximum concentration) and a vehicle control (peanut oil DAB 7) for 5 days (Monday through Friday) for 2 consecutive weeks (total of 10 treatments), a positive control (2% dinitrochlorobenzene in ether) for 5 days (Monday through Friday) for 1 week, and an untreated control. The induction period was followed by a 2 week observation period. After the observation period, a challenge test was performed with 1/10 of the induction dose for the test item and positive control groups. Previously untreated animals were also challenge tested in the same manner as the test item, vehicle control and positive control groups. Mortality and clinical abnormalities were not observed during the treatment and observation times. All animals gained considerable weight. No differences in local changes during the induction and observation period were observed between the test item treatment and vehicle control animals. No reaction was observed in the test item or vehicle control after the challenge application. Previously untreated animals tolerated the challenge application with the test item and positive control (at 1/10 of the induction dose) and vehicle without irritation and reaction. In the positive control, marked erythema was observed after three treatments, which persisted throughout the remaining induction period. The symptoms disappeared after the first day of the observation period. A distinctly circumscribed, very marked erythema developed about 3 hours after the challenge application at the treated skin site in all animals. This study is considered to be reliable with restriction (Klimisch 2) as it was conducted similar to OECD Guideline 406, however there were minor limitations in experimental design and reporting.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
One reliable (Klimisch 2) study is available to inform the sensitisation classification of the test item (1973). In the Buehler test for skin sensitisation, no effects of the test item were observed in male guinea pigs. No information is available for respiratory sensitisation. According to CLP Regulation (EC) No 1272/2008, Guidance on the Application of the CLP Criteria" (ECHA 2017) and the 8th Adaptation to Technical Progress to CLP Regulation, the test item is not classified as a skin sensitiser.
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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