Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 240-211-7 | CAS number: 16066-38-9
- 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
The dermal sensitization potential of Lupersol 221 was evaluated in Hartley-derived albino guinea pigs (Douds, 1996e). Ten male and ten female guinea pigs were topically treated with 100% Lupersol 221 (Induction I) or 75% w/v Lupersol 221 in mineral oil (Induction II and III), once per week, for three consecutive weeks. Five male and five female control guinea pigs were topically treated with 100% mineral oil, once per week for three consecutive weeks. Following a two-week rest period, a challenge was performed whereby the twenty test and ten control guinea pigs were topically treated with 0.5% w/v Lupersol 221 in mineral oil. Challenge responses in the test animals were compared with those of the control animals. Following a seven-day rest period, a rechallenge was performed whereby the twenty test animals and ten control guinea pigs were topically treated with 0.75% w/v Lupersol 221 in mineral oil. Rechallenge responses in the test animals were compared with those of the control animals. Lupersol 221: Following induction 1 with 100% Lupersol 221 dermal scores of 1 to 3 (some with very slight to slight edema, blanching, and/or eschar and one with necrosis) were noted on 19/20 test animals. Due to the severe response, the concentration was reduced to 75% for inductions 2 and 3. Dermal scores of 2 to 3 (all with very slight to slight edema and some with blanching, superficial lightening and/or eschar) were noted for all test animals at both induction 2 and 3. Following challenge with 100% mineral oil dermal scores of 0 to ± were noted for all control animals. Following challenge with 0.5% w/v Lupersol 221 in mineral oil, dermal scores of 0 to ± were noted in all test and control animals. Group mean dermal scores were noted to be similar in the test animals as compared with the control animals. Following rechallenge with 0.75% w/v Lupersol 221 in mineral oil, dermal scores of 1 were noted in 2/20 test animals and in 1/10 control animals at the 24 hour scoring interval. At the 48 hour scoring interval, dermal scores of 1 were noted in 1/10 control animals. Dermal reactions in the remaining test and control animals were limited to scores of 0 to ±. Group mean dermal scores were noted to be similar to the test animals as compared with the control animals.a-Hexylcinnamaldehyde: Usinga-Hexylcinnamaldehyde as a positive control, a study has been completed during the past six months which provided historical control data for contact sensitization to this agent utilizing the test system described herein (Modified Buehler Design). Following induction at 15% and 10% w/v and challenge at levels of 2.5% and 5% (mild concentrations) w/va-Hexylcinnamaldehyde, a contact sensitization response was observed, thereby demonstrating the susceptibility of the test system to this sensitizing agent. Based on the results of this study, Lupersol 221 is not considered to be a contact sensitizer in guinea pigs. The results of thea-Hexylcinnamaldehyde historical control study demonstrated that the test design utilized would detect potential contact sensitizers.
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- Buehler method
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Study performed before the implementation of the REACH regulation
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague Dawley, lnc., Haslett, Michigan.
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known:
- Age at study initiation: no data
- Weight at study initiation: males 347-411 g, females 329-375 g
- Housing: individually in suspended stainless steel cages
- Diet: PMI Certified Guinea Pig Chow #5026 (Purina Mills, lnc.) was provided ad libitum
- Water: Municipal tap water treated by reverse osmosis was available ad libitum
- Acclimation period: a minimum of five days
- Indication of any skin lesions: no
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 60-72
- Humidity (%): 53-77
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- induction 1, day 0
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- 75%
- Day(s)/duration:
- induction 2 and 3, days 6 and 13
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- 0.5%
- Day(s)/duration:
- Day 27
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- 0.75%
- Day(s)/duration:
- day 34
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Test: 10 males & females
Control: 5 males & females - Details on study design:
- RANGE FINDING TESTS:
The test article was utilized at 100% and at 0.05%, 0.1 %, 0.25%, 0.5%, 1 %, 5%, 10%, 15%, 25%, 50% and 75% w/v in minerai oil for the range-finding studies. - Challenge controls:
- no
- Positive control substance(s):
- yes
- Remarks:
- hexyl cinnamic aldehyde (CAS 101-86-0)
- Positive control results:
- Using Hexylcinnamaldehyde as a positive control, Springborn Laboratories, lnc., Spencerville, Ohio, has completed a study during the past six months which provided historical control data for contact sensitization to this agent utilizing the test system described herein (Modified Buehler Design). Following induction at 15% and 10% w/v and challenge at levels of 2.5% and 5% (mild concentrations) w/v Hexylcinnamaldehyde, a contact sensitization response was observed, thereby demonstrating the susceptibility of the test system to this sensitizing agent.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.75%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.75%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.75%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.75%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 5%
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 5%
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Lupersol 221 is not considered to be a contact sensitizer in guinea pigs. The results of the Hexylcinnamaldehyde historical control study demonstrated that the test design utilized would detect potential contact sensitizers.
- Executive summary:
The dermal sensitization potential of Lupersol 221 was evaluated in Hartley-derived albino guinea pigs. Ten male and ten female guinea pigs were topically treated with 100% Lupersol 221 (Induction I) or 75% w/v Lupersol 221 in mineral oil (Induction II and III), once per week, for three consecutive weeks. Five male and five female control guinea pigs were topically treated with 100% mineral oil, once per week for three consecutive weeks. Following a two-week rest period, a challenge was performed whereby the twenty test and ten control guinea pigs were topically treated with 0.5% w/v Lupersol 221 in mineral oil. Challenge responses in the test animals were compared with those of the control animals. Following a seven-day rest period, a rechallenge was performed whereby the twenty test animals and ten control guinea pigs were topically treated with 0.75% w/v Lupersol 221 in mineral oil. Rechallenge responses in the test animals were compared with those of the control animals. Lupersol 221: Following induction 1 with 100% Lupersol 221 dermal scores of 1 to 3 (some with very slight to slight edema, blanching, and/or eschar and one with necrosis) were noted on 19/20 test animals. Due to the severe response, the concentration was reduced to 75% for inductions 2 and 3. Dermal scores of 2 to 3 (all with very slight to slight edema and some with blanching, superficial lightening and/or eschar) were noted for all test animals at both induction 2 and 3. Following challenge with 100% mineral oil dermal scores of 0 to ± were noted for all control animals. Following challenge with 0.5% w/v Lupersol 221 in mineral oil, dermal scores of 0 to ± were noted in all test and control animals. Group mean dermal scores were noted to be similar in the test animals as compared with the control animals. Following rechallenge with 0.75% w/v Lupersol 221 in mineral oil, dermal scores of 1 were noted in 2/20 test animals and in 1/10 control animals at the 24 hour scoring interval. At the 48 hour scoring interval, dermal scores of 1 were noted in 1/10 control animals. Dermal reactions in the remaining test and control animals were limited to scores of 0 to ±. Group mean dermal scores were noted to be similar to the test animals as compared with the control animals.a-Hexylcinnamaldehyde: Usinga-Hexylcinnamaldehyde as a positive control, a study has been completed during the past six months which provided historical control data for contact sensitization to this agent utilizing the test system described herein (Modified Buehler Design). Following induction at 15% and 10% w/v and challenge at levels of 2.5% and 5% (mild concentrations) w/va-Hexylcinnamaldehyde, a contact sensitization response was observed, thereby demonstrating the susceptibility of the test system to this sensitizing agent. Based on the results of this study, Lupersol 221 is not considered to be a contact sensitizer in guinea pigs. The results of thea-Hexylcinnamaldehyde historical control study demonstrated that the test design utilized would detect potential contact sensitizers.
Reference
Topical Range-Finding Studies
The results of the range-finding studies indicated that a test article concentration of 100% produced moderate irritation and was considered appropriate for induction. A concentration of 0.5% w/v in minerai oil was the highest non-irritating concentration; therefore, this concentration was considered appropriate for challenge.
Sensitization Study
Following induction 1 with 100% Lupersol 221 dermal scores of 1 to 3 (some with very slight to slight edema, blanching, and/or eschar and one with necrosis) were noted on 19/20 test animals. Due to the severe response, the concentration was reduced to 75% for inductions 2 and 3. Dermal scores of 2 to 3 (all with very slight to slight edema and some with blanching, superficial lightening and/or eschar) were noted for all test animals at both induction 2 and 3. Following challenge with 100% mineral oil dermal scores of 0 to ± were noted for all control animals. Following challenge with 0.5% w/v Lupersol 221 in minerai oil, dermal scores of 0 to ± were noted in all test and control animals. Group mean dermal scores were noted to be similar in the test animals as compared with the control animals. Following rechallenge with 0.75% w/v Lupersol 221 in minerai oil, dermal scores of 1 were noted in 2/20 test animals and in 1/10 control animals at the 24 hour scoring interval. At the 48 hour scoring interval, dermal scores of 1 were noted in 1/10 control animals. Dermal reactions in the remaining test and control animals were limited to scores of 0 to ±. Group mean dermal scores were noted to be similar to the test animals as compared with the control animals.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to CLP and GHS criteria:
Not classified.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.