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EC number: 944-550-8 | 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
Data from OECD 406 guideline studies on MI3 and X14DesB30 indicate no potential for skin sensitisation. Due to very close structural similarity to Insulin DesB30, a lack of skin sensitising potential can be concluded for Insulin DesB30 as well.
See further read-across justification in document attacthed in section 13.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 90% (S2) / 0.5 ml (S3)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No signs of ill health or toxicity were observed
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 90% (S2) / 0.5 ml (S3)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No signs of ill health or toxicity were observed
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No data is available for Insulin DesB30. Data from OECD 406 guideline studies on MI3 and X14DesB30 indicate no potential for skin sensitisation. Due to very close structural similarity to Insulin DesB30, a lack of skin sensitising potential can be concluded for Insulin DesB30 as well.
See further read-across justification in document attacthed in section 13. - Executive summary:
No data is available for Insulin DesB30.
Data from OECD 406 guideline studies on MI3 and X14DesB30 indicate no potential for skin sensitisation. Due to very close structural similarity to Insulin DesB30, a lack of skin sensitising potential can be concluded for Insulin DesB30 as well.
See further read-across justification in document attacthed in section 13.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- Buehler method
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000.09.04 - 2000.10.20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- 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)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- In vivo data for MI3 skin sensitization to the guinea-pig was allready avalible prior initiating this registration dossier.
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: MI3, CHD NO. 0179/00-0665 Lot 2, Batch number: C202493
- Expiration date of the lot/batch: December 2000
- Purity 98.67 % (295 mg active sub/g crude sub)
- Purity test date: 2000.07.13
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: - 20 degrees celsius, in the dark.
- Stability under test conditions: NA
- Solubility and stability of the test substance in the solvent/vehicle: up to 90 % w/v in water.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Fresh prepared smooth brown paste (90 %w/v) using water on the day of exposure
- Final preparation of a solid: Freshly prepared smooth brown paste (90 %w/v) using water on the day of exposure
FORM AS APPLIED IN THE TEST (if different from that of starting material) freshly prepared paste (*90 %w/v) using water as vehicle.
: - Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Dunkin/Hartley, albino
- Females (if applicable) nulliparous and non-pregnant: [yes]
- Microbiological status of animals, when known: NA
- Age at study initiation: 5 - 8 weeks old.
- Weight at study initiation: 351 - 427g
- Housing: groups of five animals in suspended metal cages with wire mesh floors
- Diet (e.g. ad libitum): ad libitum, vitamin C enriched guinea pig diet.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: five days
- Indication of any skin lesions: NA
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 24 degree celsius
- Humidity (%): 30 - 70 %
- Air changes (per hr): NA
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12hrs light
- IN-LIFE DATES: From: To: 2000.09.04 - 2000.10.20 - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- MI3, 90% w/v in sterile water
- Day(s)/duration:
- on Days 1, 8 and 15.
- Adequacy of induction:
- highest technically applicable concentration used
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- MI3, 90% w/v in sterile water
- Day(s)/duration:
- Challange two weeks after the final induction and examinations after 24 and 48 hours.
- Adequacy of challenge:
- other: the maximum practical concentration that could be prepared and dosed topically and not given rise to irritating effects.
- No. of animals per dose:
- Control animals (n=10).
Test animals (n=20).
Preliminary investigations (n=4). - Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: Day 1, Day 8 and Day 15.
- Test groups: MI3 exposure, 20 animals
- Control group: Vehicle (sterile water) exposure, 10 animals
- Site: Left shoulder region
- Frequency of applications: 3 times
- Duration: 6 hours
- Concentrations: 90% w/v in sterile water
B. CHALLENGE EXPOSURE
- No. of exposures: One
- Day(s) of challenge: Two weeks after final induction
- Exposure period: 6 hours
- Test groups: MI3 exposure, 20 animals
- Control group: Exposured as test group, 10 animals
- Site: The right flank
- Concentrations: 90% w/v in sterile water
- Evaluation (hr after challenge): 6 hours
OTHER: - Challenge controls:
- yes as test animals challanged with MI3 90% v/v
- Positive control substance(s):
- yes
- Remarks:
- Hexyl cinnamic aldehyde (HCA) as 50% v/v in Alembicol D
- Positive control results:
- Induction:
Slight to well-defined dermal reactions were observed for all test animals during the induction period and no dermal reactions were observed for the control animals.
Challenge:
The dermal reaction seen in all the ten test animals were more marked than those for controls, therefore the reactions seen in all of the test animals were considered to represent evidence of skin sensitization.
Conclusion:
In this study HCA produced evidence of skin sensitization in all of the ten animals, thus confirming the sensitivity and reliability of experimental technique to detect skin sensitization potential. - Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- sterile water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of ill health or toxicity were observed
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- sterile water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of ill health or toxicity were observed
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- MI3, 90% w/v in sterile water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No signs of ill health or toxicity were observed
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- MI3, 90% w/v in sterile water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No signs of ill health or toxicity were observed
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The Study was conducted to determine the skin sensitization potential of MI3 using the guinea-pig. The study was designed in accordance with OECD guideline method 406 “modified Buehlers test”. The MI3 dose level was chosen to be 90% v/v from a preliminary study, and hexyl cinnamic aldehyde (HCA) was used as positive control. Twenty test and ten control female guinea-pigs received 3 induction applications with either MI3 (90% v/v) or water, respectively, and a challenge test two weeks after the final induction. There was no indicative of systemic toxicity or ill health for any of the guinea-pigs. In this study MI3 did not produce evidence of skin sensitization in any of the twenty test animals.
- Executive summary:
The Study was conducted to determine the skin sensitization potential of MI3 using the guinea-pig. The study was designed in accordance with OECD guideline method 406 “modified Buehlers test” the commission directive 96/54/EC, Method B6, and the US EPA Health effects test Guidelines OPPTS 870.2600. The MI3 dose level was chosen to be 90% v/v from a preliminary study and hexyl cinnamic aldehyde (HCA) was used as positive control. Twenty test and ten control female guinea-pigs received 3 induction applications on the shoulder region at Day 1, 8 or 15 with either MI3 (90% v/v) or water, respectively. All animals were challenged test two weeks after the final induction and examined after 24 or 48 hours. There was no indicative of bodyweight loss, systemic toxicity or ill health for any of the guinea-pigs. All animals exposed to HCA showed positive evidence of skin sensitization after 48 hours. In the present study, MI3 did not produce evidence of skin sensitization in any of the twenty test animals.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- Buehler method
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000.09.05 - 2000.10.20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- 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)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- n vivo data for MI3 skin sensitization to the guinea-pig was allready avalible prior initiating this registration dossier.
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: X14DesB30, CHD NO. 0180/00-0665 Lot 1, Batch number: X14IS0201014
- Expiration date of the lot/batch: December 2000
- Purity 88%
- Purity test date: 2000.07.13
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: -20 degrees celsius, in the dark.
- Stability under test conditions: NA
- Solubility and stability of the test substance in the solvent/vehicle: NA
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: defrosted and dosed as supplied
- Final preparation of a solid: dosed as supplied
.
: - Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Dunkin/Hartley, albino
- Females (if applicable) nulliparous and non-pregnant: [yes]
- Microbiological status of animals, when known: NA
- Age at study initiation: 4 - 7 weeks old.
- Weight at study initiation: 355 - 434 g
- Housing: groups of five animals in suspended metal cages with wire mesh floors
- Diet (e.g. ad libitum): ad libitum, vitamin C enriched guinea pig diet.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: five days
- Indication of any skin lesions: NA
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 24 degree celsius
- Humidity (%): 30 - 70 %
- Air changes (per hr): NA
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12hrs light
- IN-LIFE DATES: From: To: 2000.04.09 - 2000.10.20 - Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 mL of X14DesB30 as supplied (undiluted, purity of 88%) for test animals, and no X14DesB30 for the control group.
- Day(s)/duration:
- Days 1, 8 and 15. Skin contact for 6 hours per induction exposure.
- Adequacy of induction:
- highest technically applicable concentration used
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 mL X14DesB30 as supplied for both test and control animals.
- Day(s)/duration:
- exposure two weeks after final induction. challange for 6 hours and examination after 24 and 48 hours.
- Adequacy of challenge:
- other: the maximal practical concentration that could be prepared and dosed topically and not given rise to irritating effects.
- No. of animals per dose:
- Control animals (n=10).
Test animals (n=20).
Preliminary investigations (n=4). - Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: Day 1, Day 8 and Day 15.
- Test groups: X14DesB30 exposure, 20 animals
- Control group: Exposure as test group but test substance omitted, 10 animals
- Site: Left shoulder region
- Frequency of applications: 3 times
- Duration: 6 hours
- Concentrations: 0.5mL X14DesB30 as supplied
B. CHALLENGE EXPOSURE
- No. of exposures: One
- Day(s) of challenge: Two weeks after final induction
- Exposure period: 6 hours
- Test groups: X14DesB30 exposure, 20 animals
- Control group: Exposure as test group, 10 animals
- Site: The right flank
- Concentrations:0.5mL X14DesB30 as supplied
- Evaluation (hr after challenge): 6 hours
OTHER: - Challenge controls:
- Yes, as test animals challanged with X14DesB30
- Positive control substance(s):
- yes
- Remarks:
- Hexyl cinnamic aldehyde (HCA) as supplied and 50% v/v in Alembicol D
- Positive control results:
- Induction:
Slight to well-defined dermal reactions were observed for all test animals during the induction period and no dermal reactions were observed for the control animals.
Challenge:
The dermal reaction seen in all the ten test animals were more marked than those for controls, therefore the reactions seen in all of the test animals were considered to represent evidence of skin sensitization.
Conclusion:
In this study HCA produced evidence of skin sensitization in all of the ten animals, thus confirming the sensitivity and reliability of experimental technique to detect skin sensitization potential. - Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5mL X14DesB30 as supplied
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Erythema and Oedema
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5mL X14DesB30 as supplied
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Erythema and Oedema
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5mL X14DesB30 as supplied
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Erythema and Oedema
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5mL X14DesB30 as supplied
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Erythema and Oedema
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The Study was conducted to determine the skin sensitization potential of X14DesB30 using the guinea-pig. The study was designed in accordance with OECD guideline method 406 “modified Buehlers test”. The X14DesB30 dose level was chosen to be as supplied in a preliminary study, and hexyl cinnamic aldehyde (HCA) was used as positive control. Twenty test and ten control female guinea-pigs received 3 induction applications with either X14DesB30 (purity of 88%) or water, respectively, and a challenge test two weeks after the final induction. There was no indicative of systemic toxicity or ill health for any of the guinea-pigs. In this study X14DesB30 did not produce evidence of skin sensitization in any of the twenty test animals.
- Executive summary:
The Study was conducted to determine the skin sensitization potential of X14DesB30 using the guinea-pig. The study was designed in accordance with OECD guideline method 406 “modified Buehlers test” the commission directive 96/54/EC, Method B6, and the US EPA Health effects test Guidelines OPPTS 870.2600. The X14DesB30 dose level was chosen to be as supplied in a preliminary study and hexyl cinnamic aldehyde (HCA) was used as positive control. Twenty test and ten control female guinea-pigs received 3 induction applications on the shoulder region at Day 1, 8 or 15 with either X14DesB30 (purity of 88%) or water, respectively. All animals were challenged test two weeks after the final induction and examined after 24 or 48 hours. There was no indicative of bodyweight loss, systemic toxicity or ill health for any of the guinea-pigs. All animals exposed to HCA showed positive evidence of skin sensitization after 48 hours. In the present study, X14DesB30 did not produce evidence of skin sensitization in any of the twenty test animals
Referenceopen allclose all
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
Data from OECD 406 guideline studies on MI3 and X14DesB30 indicate no potential for skin sensitisation. Due to very close structural similarity to Insulin DesB30, a lack of skin sensitising potential can be concluded for Insulin DesB30 as well.
Thus, Insulin DesB30 is not to be classificied as skin sensitiser according to the CLP-criteria.
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.