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EC number: 701-196-7 | 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

Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 July 2015 - 18 July 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (2002)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- (2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- (1998)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions.
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction products of pentaerythritol, propoxylated and 1-chloro-2,3-epoxypropane with hydrogen sulfide
- EC Number:
- 701-196-7
- Cas Number:
- 72244-98-5
- Molecular formula:
- not applicable
- IUPAC Name:
- Reaction products of pentaerythritol, propoxylated and 1-chloro-2,3-epoxypropane with hydrogen sulfide
- Details on test material:
- - Name of test material (as cited in study report): GABEPRO® GPM-800
- Appearance: Colourless viscous liquid
- Test substance storage: At room temperature
- Substance type: UVCB
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Source: Charles River France, L’Arbresle Cedex, France
- Age at study initiation: 15-16 weeks
- Weight at study initiation: 3109-3281 g
- Housing: Animals were housed individually in cages with perforated floors.
- Diet: Free access to pelleted diet for rabbits (Global Diet 2030 from Harlan Teklad, Italy). Hay and wooden sticks were abailable during the study period.
- Water: Free access to tap water.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 – 24
- Humidity (%): 40 - 70
Deviations from the maximum level of daily mean relative humidity occurred. As laboratory historical data did not indicate an effect of these deviations, the study integrity was not adversely affected by the deviations.
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 07 July 2015 to 18 July 2015
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Adjacent areas of the untreated skin of each animal served as controls.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- Single application
- Observation period:
- 7 days
- Number of animals:
- 3 males
- Details on study design:
- STUDY DESIGN
The study was performed in a stepwise manner and was started by treatment of a single rabbit (sentinel). The two other animals were treated in a similar manner one week later, after considering the degree of skin irritation observed in the first animal.
TEST SITE
Approximately 24 hours before treatment, the dorsal fur was clipped with electric clippers, exposing an area of approximately 150 square centimeters (10x15 cm). To facilitate scoring, treated skin areas were re-clipped at least 3 hours before the observations.
TREATMENT
The test substance was applied to the skin of one flank, using a metalline patch of 2x3 cm. The patch was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage.
REMOVAL OF TEST SUBSTANCE
Four hours after the application, the dressing was removed and the skin cleaned of residual test substance using tap water and watery ethanol (50% v/v).
OBSERVATIONS
- Mortality/Viability: Twice daily
- Toxicity: At least once daily
- Body Weight: Day of treatment (prior to application) and after the final observation
- Necropsy: Not performed
- Irritation: The skin reactions were assessed at approximately 1, 24, 48 and 72 hours and/or 7 days after the removal of the dressings and test substance. The irritation scores and a description of all other (local) effects were recorded.
SCORING SYSTEM
The irritation was assessed according to the numerical scoring system according to OECD 404.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- (sentinel)
- Time point:
- other: 24, 48 and 72 hours (mean)
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours (mean)
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours (mean)
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal: #1 (sentinel), #2 and #3
- Time point:
- other: 24, 48 and 72 hours (mean)
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Four hours exposure to 0.5 mL of GABEPRO® GPM-800 resulted in very slight erythema and very slight oedema in the treated skin areas of the three rabbits. The skin irritation resolved within 7 days after exposure in the first animal, within 72 hours in the second animal and within 48 hours in the remaining animal. There was no evidence of a corrosive effect on the skin.
- Other effects:
- - Remnants of the test substance were present on the skin of all animals on Days 1 and 2
- No signs of systemic toxicity were observed in the animals during the test period and no mortality occurred
Any other information on results incl. tables
Animal |
930 (sentinel) |
936 |
935 |
|||||||
Time after exposure |
Erythema (0-4) |
Oedema (0-4) |
comments |
Erythema (0-4) |
Oedema (0-4) |
comments |
Erythema (0-4) |
Oedema (0-4) |
comments |
|
1 hour |
1 |
1 |
b |
1 |
1 |
b |
1 |
1 |
b |
|
24 hours |
1 |
0 |
c |
1 |
0 |
c |
1 |
0 |
c |
|
48 hours |
1 |
0 |
r |
1 |
0 |
- |
0 |
0 |
- |
|
72 hours |
1 |
0 |
r |
0 |
0 |
- |
0 |
0 |
- |
|
7 days |
0 |
0 |
- |
|
|
|
|
|
|
|
comments:
b. Sticky remnants of the test substance present.
c. Dry remnants of the test substance present.
r. Scattered erythema.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to Regulation (EC) No 1272/2008
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results obtained in a skin irritation study with rabbits, performed according to OECD/EC test guidelines, GABEPRO® GPM-800 does not need to be classified for skin irritation/corrosion in accordance with the CLP Regulation.
- Executive summary:
In an in vivo skin irritation study in rabbits, conducted in accordance with OECD 404 (2002) and according to GLP principles, 3 male rabbits were semi-occlusively exposed for 4 hours to 0.5 mL of GABEPRO® GPM-800. Exposure resulted in very slight erythema and very slight oedema in the treated skin areas of the three rabbits. The skin irritation resolved within 7 days after exposure in the first animal, within 72 hours in the second animal and within 48 hours in the remaining animal. No signs of toxicity nor mortalities were observed. Based on the result of this study, GABEPRO® GPM-800 does not need to be classified for skin irritation/corrosion in accordance with the CLP Regulation.
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.
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