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EC number: 946-364-2 | 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:
- 2015-04-21 - 2015-04-24
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The department of health of the Government of the United Kingdom
Test material
- Reference substance name:
- Reaction product of D-Glucopyranoside, methyl; esterified with oleic acid, methyl ester
- EC Number:
- 946-364-2
- Molecular formula:
- C43H78O8
- IUPAC Name:
- Reaction product of D-Glucopyranoside, methyl; esterified with oleic acid, methyl ester
- Test material form:
- liquid
- Details on test material:
- - State of aggregation: yellow liquid
-Others: storage at room temperature, in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Hsdlf:NZW
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK
- Age at study initiation: 12 to 20 weeks old
- Weight at study initiation: 2.75 or 3.0 kg
- Housing: individually in suspended cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12 hrs continuous light (06:00 to 18:00) and 12 hrs darkness.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL / site - Duration of treatment / exposure:
- 4 hrs
- Observation period:
- approximately 1, 24, 48 and 72 hrs after removal of the patches
- Number of animals:
- Two males.
The number of animals used was the minimum required to achieve the objectives of the study. Testing was conducted in two animals and the response in those animals was such that exposure of a third animal would not affect classification of the test item, no further testing was needed. - Details on study design:
- TEST SITE
On the day before the test two rabbits were clipped free of fur from the dorsal/flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.
- Area of exposure: 2.5 cm x 2.5 cm on backs
- Type of wrap if used: 2.5 cm x 2.5 cm cotton gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing: corset and patches were removed from each animal and any residual test item removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4 hrs
OBSERVATION TIME POINTS
approximately 1, 24, 48 and 72 hrs after removal of the patches
SCORING SYSTEM:
- Examination for evidence of primary irritation and scored according to the following scale:
EVALUATION OF SKIN REACTIONS
Erythema and Eschar Formation Value
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beef redness) to eschar 4
formation preventing grading of erythema
Edema Formation
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well-defined by 2
definite raising)
Moderate edema (raised approximately 1 millimeter) 3
Severe edema (raised more than 1 millimeter and 4
extending beyond the area of exposure)
Any other skin reactions and clinical signs of toxicity, if present, were also recorded.
Individual body weights were recorded on Day 0 (the day of dosing) and at the end of the observation period.
Method of calculation:
Calculation of Primary Irritation Index and Grading of Irritancy Potential Using the Draize Scheme
The scores for erythema and edema at the 24 and 72-hour readings were totaled for the two test rabbits (8 values) and this total was divided by 4 to give the primary irritation index of the test item. The test item was graded according to the following scheme devised by Draize, J.H. (1959):
Primary Irritation Index Grading of Irritancy
0 Non-irritant
> 0 to 2 Mild irritant
>2 to 5 Moderate irritant
> 5 to 8 Severe irritant
If irreversible alteration of the dermal tissue is noted in any rabbit, as judged by the Study Director, which include ulceration and clear necrosis or signs of scar tissue, the test item is considered to be corrosive to rabbit skin. Grading according to Draize may, therefore, not be applicable.
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Very slight erythema and very slight edema were noted at both treated skin sites 1 hour after patch removal.
The treated skin sites appeared normal at the 24-Hour observation. - Other effects:
- Both animals showed expected gain in body weight during the study.
Any other information on results incl. tables
Table 1: Individual Skin Reactions
Skin Reaction |
Observation Time (following patch removal) |
Individual Scores |
Total |
|
Rabbit number and Sex |
||||
75038 Male |
75039 Male |
|||
Erythema/Eschar Formation |
Immediately |
0 |
0 |
0 |
1 Hour |
1 |
1 |
(2) |
|
24 Hours |
0 |
0 |
0 |
|
48 Hours |
0 |
0 |
(0) |
|
72 Hours |
0 |
0 |
0 |
|
Edema Formation |
Immediately |
0 |
0 |
0 |
1 Hour |
1 |
1 |
(2) |
|
24 Hours |
0 |
0 |
0 |
|
48 Hours |
0 |
0 |
(0) |
|
72 Hours |
0 |
0 |
0 |
|
Sum of 24 and 72-Hour Readings (S): 0 |
0 |
|||
Pimary Irritation Index (S/4): 0/4 = |
0.0 |
|||
Grading: |
NON-IRRITANT |
( )= Total values not required for calculation of ptimary irritation index
Table 2: Individual Body Weights and Body Weight Change
Rabbit Number and Sex | Individual Body Weight (kg) | Body Weight Change (kg) | |
Day 0 | Day 3 | ||
75038 Male |
3.00 | 3.02 | 0.02 |
75039 Male |
2.75 | 2.80 | 0.05 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item produced a primary irritation index of 0.0 and was considered to be non-irritant to rabbit skin according to the Draize scheme. No corrosive effects were noted.
- Executive summary:
The primary dermal irritation potential of the test item was evaluated in this study with New Zealand White rabbits (2M) in accordance with OECD Guideline 404 and GLP requirements. There was one group of two male albino rabbits that received a single, four-hour, semioccluded exposure. Each 0.5 mL dose of the test article was applied to the clipped, unabraded skin. At completion of exposure, the bandages were removed and the sites washed. Application sites were evaluated in accordance with the method of Draize at approximately 1 and 24, 48 and 72 hours after patch removal. There were no remarkable body weight changes during the study period. The test article induced very slight erythema and edema on all animals at 1 hrs after removal of the patch. The skin appeared normal again at 24 hrs. No corrosive effects were noted. The Primary Irritation Index was calculated to be 0.0. The test article received a descriptive rating classification of non-irritating.
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