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EC number: 257-048-2 | CAS number: 51200-87-4
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 April - 08 June 1979
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- skin irritation / corrosion, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 April - 08 June 1979
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- other: Shelanski (Combination method)
- Deviations:
- not specified
- Principles of method if other than guideline:
- - Principle of test:
Shelanski (Combination method)
- Short description of test conditions:
A total of 105 individuals was selected to participate in this evaluation. The procedure is a double-blind evaluation of the test material in a randomy selected group from the local population.
Induction was done through a series of twelve consecutive daily applications, each of twenty-four hours duration, was scheduled to be carried out during the induction period (weeks #1, 2 and 3). In week #1 and #2 the test material was applied in a concentration of 3.0 % w/v in water; in week #3 the test material was applied in a concentration of 0.3 % w/v in water.
Challenge was done through one application with a concentration of 0.3 % w/v of the test material in water on virgin sites during the challenge week (week #6).
An additional challenge application was done with 2 individuals with a concentration 0.1 % w/v of the test substance in water (week #8).
Site definition: A site on the arm of each individual was selected and identified for contact with the test material.
Patch definition: Specially prepared Parke-Davis Readi-Bandages werde used in this procedure. 0.2 ml of the test material was applied to the webril pads of occlusive Readi-Bandages. The patches were then applied to the sites.
- Parameters analysed / observed:
Direct effects: Immediate Primary Irritation and/or Fatigue or Cumulative Primary Irritation
Indirect effects (Hypersensitivity): Immediate Reaction Type (Histamine release, phenomenon, wheal and flare, urticaria, Arthus penomenon), Delayed Reaction Type (Macular or maculo-papular eruptions, induration, itching) - GLP compliance:
- not specified
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Name: Amine CS-1135
- Source and lot No: Received from International Minerals and Chemical Corporation at 16 April 1979, Lot No. 55
- Description: clear liquid
- Purity: 78%
PREPARATION OF THR TEST MATERIAL
3 g of the original test material was diluted to 100 ml in water to form a 3 % v/v emulsion in water.
300 mg of the original test material was diluted to 100 ml in water to form a 0.3 % w/v emulsion in water.
100 mg of the original test material was diluted to 100 ml in water to form a 0.1 % w/v emulsion in water. - Species:
- other: human
- Details on test animals or test system and environmental conditions:
- TESTED POPULATION
- Source: Randomly selected group from the local population
Adults (18 years and older) from local population were recruited to participate.
Criteria for initial qualification:
1. Willingness to cooperate
2. Dependability and perserverance.
3. Ability to understand the purpose of the procedure and what was required of him or her.
4. Ability to understand the risks involved and to make a reasonable judgment to participate.
5. Ability to understand the items in the consent form which he or she was required to sign before the start of the study.
Exclusion Criteria:
A history of past and present health status and medication intake was obtained from each of the individuals being considered a brief physical examination was performed in order to detect and eliminate any who evidenced any finding which could be considered a basis for exclusion.
Candidates were exeluded for any one of the following reasons:
1. Systemic illnes which might have contra-indicated participation.
2. Skin disease with manifestions wich might be confused with effects of the test material.
3. Intake of medications which might augment or impede the irritant effects of the test material. - Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.2 ml of solution
- Concentration:
3.0 % v/v of solution (diluted with water) on weeks #1 and #2
0.3 % v/v of solution (diluted with water) on week #3
- Duration of treatment / exposure:
- - Induction was done through a series of twelve consecutive daily applications, each of twenty-four hours duration, four applications per week, four applications per week, was scheduled to be carried out during the induction period (weeks #1, 2 and 3).
- Challenge was done through one application on virgin sites during the challenge week (week #6) - Observation period:
- 6 weeks
- Number of animals:
- 101
- Details on study design:
- TEST SITE :
- Type of wrap: Parke-Davis Readl-Bandages
REMOVAL OF TEST SUBSTANCE
- Washing: no
OBSERVATION TIME POINTS
After every 24 h application
SCORING SYSTEM:
- Area of exposure: Arm
- Type of wrap if used: Parke-Davis Readi-Bandages. 0.2 ml of the test material was applied to the webril pads of occlusive Readi-Bandages. The adhesive was pressed all around to assure firm contact of the test material against the skin and to form a seal against loss of moisture. - Irritation parameter:
- primary dermal irritation index (PDII)
- Remarks:
- 3% w/v solution
- Basis:
- other: 101 human volunteers
- Time point:
- other: 24 h after repeated application
- Score:
- ca. 70.3
- Reversibility:
- fully reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- Presence of visible irritation after two or more consecutive 24h applications
- Irritation parameter:
- other: Primary irritant effect of the cumulative type (% individuals showing irritation)
- Remarks:
- 0.3% w/v solution
- Basis:
- other: 101 human volunteers
- Time point:
- other: 24 h after four 24h application
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- Presence of visible irritation after two or more consecutive 24h applications
- Irritant / corrosive response data:
- No significant irritation was recorded as a result of the first application.
The presence of visible irritation after two or more applications indicates that the sample material tested at 3.0% w/v emulsion in water did excert a primary irritant effect of the cumulative type in 70.3 % of the individuals under test.
The presence of visible irritation after two or more applications on week #3 indicates that the sample material tested at 0.3 w/v emulsion in water did excert a primary irritant effect of the cumulative type in 6.9 % of the individuals under test. - Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- CS-1135 is a skin irritant.
- Executive summary:
Amine CS-1135 (P-1952, 4,4-dimethyl-1,3-oxazolidine or Oxazolidine A 78% plus Water 22% by weight) Lot No. 55, was submitted to Product Investigations, Inc., Conshohocken, PA, for potential assessment of dermal irritation and sensitization hazard in human volunteers.
A series of twelve, 24 hr applications, four applications per week of Amine CS-1135 were applied to the intact skin. Each application consisted of 0.2 m1 solution of Amine CS-1135 under an occlusive patch. Initially, a 3.0 % solution of Amine CS-1135 was applied but by the end of the second week, 60% of the subjects were exhibiting irritation at the application site. Thus, for the third week repeat applications of the concentration of CS-1135 was reduced to 0.3%.
After two weeks of rest a virgin site was challenged with 0.3% CS-1135 solution. Only two subjects out of 101 showed any skin reaction within the four-day observation period. The same two subjects upon rechallenge with a 0.1% CS-1135 solution at a virgin site showed no skin reaction.
A 3% CS-1135 solution produces fatiguing and irritation to the human skin but it does not elicite a sensitization reaction. The 95 percentile confidence limits, where CS-1135 will not elicite any sensitization reactions are 96.41 to 100%, for n = 101.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Shelanski (Combination method)
- Deviations:
- not specified
- Principles of method if other than guideline:
- - Principle of test: Shelanski (Combination method)
- Short description of test conditions:
A total of 105 individuals was selected to participate in this evaluation. The procedure is a double-blin
d evaluation of the test material in a randomy selected group from the local population.
Induction was done through a series of twelve consecutive daily applications, each of twenty-four h
ours duration, was scheduled to be carried out during the induction period (weeks #1, 2 and 3). In
week #1 and #2 the test material was applied in a concentration of 3.0 % w/v in water; in week #3 the
test material was applied in a concentration of 0.3 % w/v in water.
Challenge was done through one application with a concentration of 0.3 % w/v of the test material in
water on virgin sites during the challenge week (week #6).
An additional challenge application was done with 2 individuals with a concentration 0.1 % w/v of the
test substance in water (week #8).
Site definition: A site on the arm of each individual was selected and identified for contact with the
test material.
Patch definition: Specially prepared Parke-Davis Readi-Bandages werde used in this procedure. 0.2
ml of the test material was applied to the webril pads of occlusive Readi-Bandages. The patches were
then applied to the sites.
- Parameters analysed / observed:
Direct effects: Immediate Primary Irritation and/or Fatigue or Cumulative Primary Irritation
Indirect effects (Hypersensitivity): Immediate Reaction Type (Histamine release, phenomenon,
wheal and flare, urticaria, Arthus penomenon), Delayed Reaction Type (Macular or maculo-papular
eruptions, induration, itching) - GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- The study was conducted before the OECD Guideline 429: Skin Sensitisation Local Lymph Node Assay came into force in 2002.
Test material
- Reference substance name:
- 4,4-dimethyloxazolidine
- EC Number:
- 257-048-2
- EC Name:
- 4,4-dimethyloxazolidine
- Cas Number:
- 51200-87-4
- Molecular formula:
- C5H11NO
- IUPAC Name:
- 4,4-dimethyl-1,3-oxazolidine
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot No: Received from International Minerals and Chemical Corporation at 16 April 1979,
Lot No. 55
- Description: clear liquid
- Purity: 78%
In vivo test system
Test animals
- Species:
- other: human
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TESTED POPULATION
- Source: Randomly selected group from the local population
Adults (18 years and older) from local population were recruited to participate.
Criteria for initial qualification:
1. Willingness to cooperate
2. Dependability and perserverance.
3. Ability to understand the purpose of the procedure and what was required of him or her.
4. Ability to understand the risks involved and to make a reasonable judgment to participate.
5. Ability to understand the items in the consent form which he or she was required to sign before the
start of the study.
Exclusion Criteria:
A history of past and present health status and medication intake was obtained from each of the
individuals being considered a brief physical examination was performed in order to detect and eli
minate any who evidenced any finding which could be considered a basis for exclusion.
Candidates were exeluded for any one of the following reasons:
1. Systemic illnes which might have contra-indicated participation.
2. Skin disease with manifestions wich might be confused with effects of the test material.
3. Intake of medications which might augment or impede the irritant effects of the test material.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3% w/v solution
- No. with + reactions:
- 1
- Total no. in group:
- 101
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3% w/v solution
- No. with + reactions:
- 1
- Total no. in group:
- 100
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 3% w/v solution
- No. with + reactions:
- 0
- Total no. in group:
- 101
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- other: Rechallenge of two individuals that showed positive reaction on first challenge
- Dose level:
- 0.1 % w/v
- No. with + reactions:
- 0
- Total no. in group:
- 2
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: rechallenge 2nd reading
- Hours after challenge:
- 48
- Group:
- other: Rechallenge of two individuals that showed positive reaction on first challenge
- Dose level:
- 0.1% w/v
- No. with + reactions:
- 0
- Total no. in group:
- 2
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: rechallenge 3rd reading
- Hours after challenge:
- 72
- Group:
- other: Rechallenge of two individuals that showed positive reaction on first challenge
- No. with + reactions:
- 0
- Total no. in group:
- 2
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
No significant irritation was recorded as a result of the first application.
The presence of visible irritation after two or more applications indicates that the sample material tes
ted at 3.0% w/v emulsion in water did excert a primary irritant effect of the cumulative type in 70.3 %
of the individuals under test.
The presence of visible irritation after two or more applications on week #3 indicates that the sample
material tested at 0.3 w/v emulsion in water did excert a primary irritant effect of the cumulative type
in 6.9 % of the individuals under test.
Challenge period: 0.3% w/v emulsion in water
The test material, tested at 0.3% w/v emulsion in water was well tolerated by all but two panelists.
Additional Challenge period: 0.1% w/v emulsion in water
The absence of any significant reaction in the two panelists indicate that this dilution of the test material, 0.1% w/v solution in water, was incapable of eliciting a response wich could be interpreted as evidence that sensitization has occured.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The results indicate that, though a 3.05 w/v dilution of the test material was capable of irritating the skin of 70.3% of the test panel, it was not capable of eliciting a state of hypersensitivity in any of the individuals.
The 95 percentile confidence limits, where CS-1135 will not elicite any sensitization reactions are 96.41 to 100%, for n = 101. - Executive summary:
Amine CS-1135 (P-1952, 4,4-dimethyl-1,3-oxazolidine or Oxazolidine A 78% plus water 22% by weight) Lot No. 55, was submitted to Product Investigations, Inc., Conshohocken, PA, for potential assessment of dermal irritation and sensitization hazard in human volunteers. A series of twelve, 24 hr applications, four applications per week of Amine CS-1135 were applied to the intact skin. Each application consisted of 0.2 m1 solution of Amine CS-1135 under an occlusive patch.
Initially, a 3.0 % solution of Amine CS-1135 was applied but by the end of the second week, 60% of the subjects were exhibiting irritation at the application site. Thus, for the third week repeat applications of the concentration of CS-1135 was reduced to 0.3%. After two weeks of rest a virgin site was challenged with 0.3% CS-1135 solution.
Only two subjects out of 101 showed any skin reaction within the four-day observation period. The same two subjects upon rechallenge with a 0.1% CS-1135 solution at a virgin site showed no skin reaction. A 3% CS-1135 solution produces fatiguing and irritation to the human skin but it does not elicite a sensitization reaction. The 95 percentile confidence limits, where CS-1135 will not elicite any sensitization reactions are 96.41 to 100%, for n = 101.
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