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EC number: 918-973-3 | CAS number: 1174522-45-2
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- 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 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:
- exposure-related observations in humans: other data
- Type of information:
- read-across based on grouping of substances (category approach)
- 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 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
- Type of study / information:
- Determination of Phototoxicity and Primary Irritancy.
- 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 the phase II study was the determination of Phototoxicity and Primary Irritancy of MRD-88-295 in Human skin.
The procedure required the concurrent application of the test materials on corresponding heterolateral sites of the upper arms of each panelist.
On each arm, 4 test sites were used a 5th site serving as a control (no test material applied).
Day 1: each testing site had 0.3 mL of a 50% w/w MRD-88-295 solution applied to it and held in contact with the skin for 24 hours under a semi-occlusive dressing.
Day 2: After 24 hours, participants returned and had 0.3 mL of a neat solution of MRD-88-295 or water (if control) was applied to the same sites, which was removed after 10 minutes. The right arm was exposed to 15 min UV-A followed by 1 MED of UV-B (phototoxicity) and the left arm was not (primary irritant study), both arms were examined for irritation. Participants returned at 24, 48 and 72 hours for an examination for dermal irritation. - GLP compliance:
- yes (incl. QA statement)
- Ethical approval:
- confirmed, but no further information available
- Details on study design:
- SUBJECTS
- Number of subjects exposed: 30
- Sex: male and female, no additional 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
TYPE OF TEST(S) USED: patch test
ADMINISTRATION
- Type of application: semiocclusive
- Description of patch: adhesive strips (not sterilized)
- Vehicle / solvent: U.S.P. petrolatum
- Concentrations: 50% w/w
- Volume applied: 0.3 g
- Removal of test substance: the excess was removed by wiping gently with a facial tissue - Exposure assessment:
- measured
- Details on exposure:
- TYPE OF EXPOSURE: Semi-occlusive patch
EXPOSURE PERIOD: 24 hours - Results:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: no symptoms
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 30
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0 - Conclusions:
- Under the test conditions, MRD-88-295 did not elicit any effects which could be considered as characteristic of a photoxic propensity or a primary irritant.
- 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 II study was performed in order to determine the Phototoxicity and the Primary irritancy propensities of MRD-88-295 in human skin.
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.
The Phase II study was performed with a panel of 30 volunteers. The test substance was diluted at 50% w/w in petrolatum and 0.3 g of solution were applied to skin of volunteers under semi-occlusive patches for a period of 24 hours. The control site was also covered with a similar semi-occlusive bandage without test substance. After exposure, skin examinations were conducted. After first exposure, participants received 0.3 g of undiluted MRD-88-295 (or water for negative control site) on the same sites, which was removed after 10 minutes. Then, for the phototoxicity determination, the right arm was exposed to 15 min UV-A followed by 1 MED of UV-B. The left arm was not exposed to UV to determine the primary irritancy. Both arms were examined for dermal irritation at 24, 48 and 72 hours after exposure.Skin reaction was not observed in any subjects.
Under the test conditions, MRD-88-295 did not elicit any effects which could be construed as characteristic of a phototoxic propensity or a primary irritant.
Table 7.10.4/2: Intensity of responses observed on irradiated and control sites (upper Right Arm)
Sites treated with MRD-88-295 |
Sites NOT Treated with MRD-88-295 |
||||||||||
Subject number |
M (1) |
T (2) |
W (3) |
Th (4) |
F (5) |
M (1) |
T (2) |
W (3) |
Th (4) |
F (5) |
|
1 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
2 |
0 |
0 |
1 |
1 |
1 |
|
0 |
0 |
1 |
1 |
1 |
3 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
4 |
0 |
0 |
1 |
1 |
1 |
|
0 |
0 |
1 |
1 |
1 |
5 |
0 |
0 |
1 |
1 |
1 |
|
0 |
0 |
1 |
1 |
1 |
6 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
7 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
8 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
9 |
0 |
0 |
1 |
1 |
1 |
|
0 |
0 |
1 |
1 |
1 |
10 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
11 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
12 |
0 |
0 |
1 |
1 |
1 |
|
0 |
0 |
1 |
1 |
1 |
13 |
0 |
0 |
1 |
1 |
1 |
|
0 |
0 |
1 |
1 |
1 |
14 |
0 |
0 |
1 |
1 |
1 |
|
0 |
0 |
1 |
1 |
1 |
15 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
16 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
17 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
18 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
19 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
20 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
21 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
22 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
23 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
24 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
25 |
0 |
0 |
1 |
1 |
1 |
|
0 |
0 |
1 |
1 |
1 |
26 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
27 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
28 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
29 |
0 |
0 |
1 |
1 |
1 |
|
0 |
0 |
1 |
1 |
1 |
30 |
0 |
0 |
1 |
1 |
1 |
|
0 |
0 |
1 |
1 |
1 |
(1) Baseline - Examination before application of test material.
(2) Results of examination after 24 hours of contact with either the test material or control.
(3) Results of examination 24 hours post-irradiation.
(4) Results of examination 48 hours post-irradiation.
(5) Results of examination 72 hours post-irradiation.
- 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 study / information:
- Determination of Phototoxicity and Primary Irritancy.
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 the phase II study was the determination of Phototoxicity and Primary Irritancy of MRD-88-295 in Human skin.
The procedure required the concurrent application of the test materials on corresponding heterolateral sites of the upper arms of each panelist.
On each arm, 4 test sites were used a 5th site serving as a control (no test material applied).
Day 1: each testing site had 0.3 mL of a 50% w/w MRD-88-295 solution applied to it and held in contact with the skin for 24 hours under a semi-occlusive dressing.
Day 2: After 24 hours, participants returned and had 0.3 mL of a neat solution of MRD-88-295 or water (if control) was applied to the same sites, which was removed after 10 minutes. The right arm was exposed to 15 min UV-A followed by 1 MED of UV-B (phototoxicity) and the left arm was not (primary irritant study), both arms were examined for irritation. Participants returned at 24, 48 and 72 hours for an examination for dermal irritation. - GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Hydrocarbons, C14-C19, isoalkanes, cyclics, <2% aromatics
- EC Number:
- 920-114-2
- Molecular formula:
- None available. Not a single isomer - see remarks.
- 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
- Physical type: Clear Colorless Liquid
- Analytical purity: 100% Commercial product
- Lot/batch No.: 1
- Storage condition of test material: at room temperature
Constituent 1
Constituent 2
Constituent 3
Method
- Ethical approval:
- confirmed, but no further information available
- Details on study design:
- SUBJECTS
- Number of subjects exposed: 30
- Sex: male and female, no additional 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
TYPE OF TEST(S) USED: patch test
ADMINISTRATION
- Type of application: semiocclusive
- Description of patch: adhesive strips (not sterilized)
- Vehicle / solvent: U.S.P. petrolatum
- Concentrations: 50% w/w
- Volume applied: 0.3 g
- Removal of test substance: the excess was removed by wiping gently with a facial tissue - Exposure assessment:
- measured
- Details on exposure:
- TYPE OF EXPOSURE: Semi-occlusive patch
EXPOSURE PERIOD: 24 hours
Results and discussion
- Results:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: no symptoms
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 30
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0
Any other information on results incl. tables
Table 7.10.4/2: Intensity of responses observed on irradiated and control sites (upper Right Arm)
Sites treated with MRD-88-295 |
Sites NOT Treated with MRD-88-295 |
||||||||||
Subject number |
M (1) |
T (2) |
W (3) |
Th (4) |
F (5) |
M (1) |
T (2) |
W (3) |
Th (4) |
F (5) |
|
1 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
2 |
0 |
0 |
1 |
1 |
1 |
|
0 |
0 |
1 |
1 |
1 |
3 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
4 |
0 |
0 |
1 |
1 |
1 |
|
0 |
0 |
1 |
1 |
1 |
5 |
0 |
0 |
1 |
1 |
1 |
|
0 |
0 |
1 |
1 |
1 |
6 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
7 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
8 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
9 |
0 |
0 |
1 |
1 |
1 |
|
0 |
0 |
1 |
1 |
1 |
10 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
11 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
12 |
0 |
0 |
1 |
1 |
1 |
|
0 |
0 |
1 |
1 |
1 |
13 |
0 |
0 |
1 |
1 |
1 |
|
0 |
0 |
1 |
1 |
1 |
14 |
0 |
0 |
1 |
1 |
1 |
|
0 |
0 |
1 |
1 |
1 |
15 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
16 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
17 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
18 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
19 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
20 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
21 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
22 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
23 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
24 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
25 |
0 |
0 |
1 |
1 |
1 |
|
0 |
0 |
1 |
1 |
1 |
26 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
27 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
28 |
0 |
0 |
1 |
1 |
0 |
|
0 |
0 |
1 |
1 |
0 |
29 |
0 |
0 |
1 |
1 |
1 |
|
0 |
0 |
1 |
1 |
1 |
30 |
0 |
0 |
1 |
1 |
1 |
|
0 |
0 |
1 |
1 |
1 |
(1) Baseline - Examination before application of test material.
(2) Results of examination after 24 hours of contact with either the test material or control.
(3) Results of examination 24 hours post-irradiation.
(4) Results of examination 48 hours post-irradiation.
(5) Results of examination 72 hours post-irradiation.
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, MRD-88-295 did not elicit any effects which could be considered as characteristic of a photoxic propensity or a primary irritant.
- 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 II study was performed in order to determine the Phototoxicity and the Primary irritancy propensities of MRD-88-295 in human skin.
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.
The Phase II study was performed with a panel of 30 volunteers. The test substance was diluted at 50% w/w in petrolatum and 0.3 g of solution were applied to skin of volunteers under semi-occlusive patches for a period of 24 hours. The control site was also covered with a similar semi-occlusive bandage without test substance. After exposure, skin examinations were conducted. After first exposure, participants received 0.3 g of undiluted MRD-88-295 (or water for negative control site) on the same sites, which was removed after 10 minutes. Then, for the phototoxicity determination, the right arm was exposed to 15 min UV-A followed by 1 MED of UV-B. The left arm was not exposed to UV to determine the primary irritancy. Both arms were examined for dermal irritation at 24, 48 and 72 hours after exposure.Skin reaction was not observed in any subjects.
Under the test conditions, MRD-88-295 did not elicit any effects which could be construed as characteristic of a phototoxic propensity or a primary irritant.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)