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EC number: 214-300-6 | CAS number: 1120-21-4
- 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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- From 1988-08-26 to 1988-11-11
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Procedure perdormed in compliance with Good Clinical Practice. Study conducted according to acceptable scientific conditions; number of volunteers, applied dose, observation time and observed parameters are acceptable. Substance identification: commercial name available from industrial for code name Substance analytical certificate not available in the report
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- sensitisation data (humans)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- From 1988-08-26 to 1988-11-11
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Procedure perdormed in compliance with Good Clinical Practice. Study conducted according to acceptable scientific conditions; number of volunteers, applied dose, observation time and observed parameters are acceptable. Substance identification: commercial name available from industrial for code name Substance analytical certificate not available in the report
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- reference to same study
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: No symptoms observed.
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 29
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0
OTHER RESULTS:
Responses of greater intensity than the degree of erythema usually anticipated with 2 MED's were not observed in any of the 29 panelists on the irradiated sites occupied by the test material during the induction phase. - Conclusions:
- Under the test conditions, MRD-88-295 is not considered as a photocontact allergen, a primary irritant or a contact allergen.
- Executive summary:
This data is being read across from the source study that tested Hydrocarbons, C14 -C19, isoalkanes, cyclics, <2% aromatics based on analogue read across.
This study included three phases which evaluated different propensities of the MRD-88-295 test substance as the first phase was only a preliminary test condition study.
The phase III of the study was performed to determine the potential of MRD-88-295 to cause dermal irritation and sentization in humans with or without UV irradiation.
A preliminary Phase I study was conducted to determine the Minimum Erythemogenic Dose (MED) for each member of a group of thirty panelists when the skin is irradiated by UV-B light. The least duration of UV-B exposure which produced erythema of Grade 1 or greater was selected as the MED value for each panelist. One volunteer was dropped out at the end of the phase II of the study.
Twenty-nine humans were exposed to MRD-88-295 for 24 hours followed by UV-B and UV-A irradiation (during three weeks). Then, exposure to MRD-88-295 was repeated for 24 hours. Dermal examinations occured at 24, 48 and 72 h test substance post-exposure. Dermal irritation and damage was scored according to a modified Draize scale. The most severe reaction noted in all experimental paradigms was noted as a "1" for slight erythema. MRD-88-295 did not elicit any effects which could be construed as a characteristic of a phototoxic propensity or of a primary irritant. MRD-88-295 showed no evidence being a photocontact allergen and no evidence of being either a primary irritant or a contact allergen.
Under these test conditions, MRD-88-295 was not classified as a irritant to skin and a skin sensitiser.
Table 7.10.4/2: Preliminary Phase I Study results: Intensity of responses observed on irradiated sites:
Duration of Exposure |
|||||
Subject number |
10 seconds |
20 seconds |
30 seconds |
40 seconds |
50 seconds |
1 |
0 |
0 |
1 |
2 |
3 |
2 |
0 |
0 |
1 |
2 |
2 |
3 |
0 |
0 |
1 |
2 |
3 |
4 |
0 |
0 |
0 |
1 |
3 |
5 |
0 |
0 |
1 |
2 |
3 |
6 |
0 |
1 |
1 |
2 |
3 |
7 |
0 |
0 |
1 |
1 |
2 |
8 |
0 |
1 |
1 |
2 |
3 |
9 |
0 |
0 |
1 |
2 |
2 |
10 |
0 |
0 |
1 |
1 |
2 |
11 |
0 |
0 |
1 |
2 |
2 |
12 |
0 |
0 |
1 |
2 |
3 |
13 |
0 |
0 |
1 |
2 |
3 |
14 |
0 |
0 |
0 |
1 |
3 |
15 |
0 |
0 |
1 |
2 |
3 |
16 |
0 |
0 |
0 |
1 |
3 |
17 |
0 |
0 |
0 |
1 |
2 |
18 |
0 |
0 |
1 |
2 |
3 |
19 |
0 |
0 |
1 |
1 |
2 |
20 |
0 |
1 |
2 |
2 |
3 |
21 |
0 |
0 |
0 |
1 |
3 |
22 |
0 |
0 |
1 |
2 |
3 |
23 |
0 |
0 |
1 |
1 |
2 |
24 |
0 |
0 |
1 |
1 |
2 |
25 |
0 |
0 |
1 |
2 |
3 |
26 |
0 |
0 |
1 |
1 |
3 |
27 |
0 |
0 |
0 |
1 |
3 |
28 |
0 |
0 |
1 |
2 |
2 |
29 |
0 |
0 |
1 |
1 |
3 |
30 |
0 |
1 |
1 |
2 |
3 |
Irritating reactions were observed for the 30 panelists. The least duration of UV-B exposure which produced erythema of Grade 1 (considered as the qualifying erythematous reaction) or greater was selected as the MED value for each panelist.
In four individuals, an exposure of 20 seconds of UV-B sufficed to produce the qualifying erythematous reactions. Exposure of 30 seconds in twenty individuals and 40 seconds in six individuals were required to achieve the same intensity of response.
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- A preliminary Phase I study was conducted to determine the Minimum Erythemogenic Dose (MED) for each member of a group of thirty panelists when the skin of each is irradiated by UV-B light.
The aim of this Phase III study was the determination of the photocontact and contact allergenic capabilities of MRD-88-295 in Human skin.
This study was performed with the same 30 panelists of the phase I.
On each side of the back, 9 test sites were used for experimental purposes with 10th site serving as a control (no test substance applied). The left side of the back was used to evaluate the irritant and contact allergenic propensities. The evaluation of photocontact irritation and allergenic propensities were performed on the right side. MRD-88-295 solution at 50% in petrolatum was used at each experimental site for the evaluation of the propensities. - GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Hydrocarbons, C14-C19, isoalkanes, cyclics, <2% aromatics
- EC Number:
- 920-114-2
- IUPAC Name:
- Hydrocarbons, C14-C19, isoalkanes, cyclics, <2% aromatics
- Reference substance name:
- Isopar V
- IUPAC Name:
- Isopar V
- Reference substance name:
- MRD-88-295
- IUPAC Name:
- MRD-88-295
- Details on test material:
- - Name of test material (as cited in study report): MRD-88-295
- Substance type: petroleum product, UVCB
- Analytical purity: 100% Commercial product
- Physical type: Clear Colorless Liquid
- Lot/batch No.: 1
- Storage condition of test material: at room temperature
Constituent 1
Constituent 2
Constituent 3
Method
- Type of population:
- general
- Ethical approval:
- confirmed, but no further information available
- Subjects:
- - Number of subjects exposed: 29
- Sex: male and female, no additional data
- Age: no data
- Race: no data
- Demographic information: no data
- other : panel 88-70 - Clinical history:
- A past/present medical history and a brief physical was performed and obtained for each individual. Candidates were excluded for any one of the following reasons: systemic illness which might have contra-indicated participation in another sensitization study within the past 10 weeks.
- Controls:
- Controls were performed
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test and UV exposure
ADMINISTRATION
- Type of application: semi-occlusive
- Description of patch: adhesive strips
- Vehicle / solvent: petrolatum
- Concentrations: 50% w/w
- Volume applied: 0.3g
- Testing/scoring schedule: according to a modified Draize scale
- Removal of test substance: no data
CONTROL:
Negative control was conducted in the same way as described above (semi-occlusive patch) but without test substance administration.
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: No symptoms observed.
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 29
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0
OTHER RESULTS:
Responses of greater intensity than the degree of erythema usually anticipated with 2 MED's were not observed in any of the 29 panelists on the irradiated sites occupied by the test material during the induction phase.
Any other information on results incl. tables
Table 7.10.4/2: Preliminary Phase I Study results: Intensity of responses observed on irradiated sites:
Duration of Exposure |
|||||
Subject number |
10 seconds |
20 seconds |
30 seconds |
40 seconds |
50 seconds |
1 |
0 |
0 |
1 |
2 |
3 |
2 |
0 |
0 |
1 |
2 |
2 |
3 |
0 |
0 |
1 |
2 |
3 |
4 |
0 |
0 |
0 |
1 |
3 |
5 |
0 |
0 |
1 |
2 |
3 |
6 |
0 |
1 |
1 |
2 |
3 |
7 |
0 |
0 |
1 |
1 |
2 |
8 |
0 |
1 |
1 |
2 |
3 |
9 |
0 |
0 |
1 |
2 |
2 |
10 |
0 |
0 |
1 |
1 |
2 |
11 |
0 |
0 |
1 |
2 |
2 |
12 |
0 |
0 |
1 |
2 |
3 |
13 |
0 |
0 |
1 |
2 |
3 |
14 |
0 |
0 |
0 |
1 |
3 |
15 |
0 |
0 |
1 |
2 |
3 |
16 |
0 |
0 |
0 |
1 |
3 |
17 |
0 |
0 |
0 |
1 |
2 |
18 |
0 |
0 |
1 |
2 |
3 |
19 |
0 |
0 |
1 |
1 |
2 |
20 |
0 |
1 |
2 |
2 |
3 |
21 |
0 |
0 |
0 |
1 |
3 |
22 |
0 |
0 |
1 |
2 |
3 |
23 |
0 |
0 |
1 |
1 |
2 |
24 |
0 |
0 |
1 |
1 |
2 |
25 |
0 |
0 |
1 |
2 |
3 |
26 |
0 |
0 |
1 |
1 |
3 |
27 |
0 |
0 |
0 |
1 |
3 |
28 |
0 |
0 |
1 |
2 |
2 |
29 |
0 |
0 |
1 |
1 |
3 |
30 |
0 |
1 |
1 |
2 |
3 |
Irritating reactions were observed for the 30 panelists. The least duration of UV-B exposure which produced erythema of Grade 1 (considered as the qualifying erythematous reaction) or greater was selected as the MED value for each panelist.
In four individuals, an exposure of 20 seconds of UV-B sufficed to produce the qualifying erythematous reactions. Exposure of 30 seconds in twenty individuals and 40 seconds in six individuals were required to achieve the same intensity of response.
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, MRD-88-295 is not considered as a photocontact allergen, a primary irritant or a contact allergen.
- Executive summary:
This study included three phases which evaluated different propensities of the MRD-88-295 test substance as the first phase was only a preliminary test condition study.
The phase III of the study was performed to determine the potential of MRD-88-295 to cause dermal irritation and sentization in humans with or without UV irradiation.
A preliminary Phase I study was conducted to determine the Minimum Erythemogenic Dose (MED) for each member of a group of thirty panelists when the skin is irradiated by UV-B light. The least duration of UV-B exposure which produced erythema of Grade 1 or greater was selected as the MED value for each panelist. One volunteer was dropped out at the end of the phase II of the study.
Twenty-nine humans were exposed to MRD-88-295 for 24 hours followed by UV-B and UV-A irradiation (during three weeks). Then, exposure to MRD-88-295 was repeated for 24 hours. Dermal examinations occured at 24, 48 and 72 h test substance post-exposure. Dermal irritation and damage was scored according to a modified Draize scale. The most severe reaction noted in all experimental paradigms was noted as a "1" for slight erythema. MRD-88-295 did not elicit any effects which could be construed as a characteristic of a phototoxic propensity or of a primary irritant. MRD-88-295 showed no evidence being a photocontact allergen and no evidence of being either a primary irritant or a contact allergen.
Under these test conditions, MRD-88-295 was not classified as a irritant to skin and a skin sensitiser.
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