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EC number: 701-308-4 | 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

Endpoint summary
Administrative data
Description of key information
The substance has no acid-/alkaline reserve.
Skin irritation was studied according to OECD Guideline 404 and EU Method B.4. The substance obtained an overall irritation score of 0.17. Small Vinyl Ester is considered as not irritating to skin.
Eye irritation was studied according to OECD Guideline no. 437. The substance obtained an irritation similar to the negative control. The substance is considered as not irritating to eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- In vivo study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 24 h exposure to test substance on both shaved and shaved/abrased sites on the trunk of rabbits
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 24 h exposure to test substance on both shaved and shaved/abrased sites on the trunk of rabbits
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- 6 adult albino-rabbits
- Source: Not specified
- Age at study initiation: Not specified (adult)
- Weight at study initiation: Average weight 2.5 kg
- Housing: Single cages
- Diet (e.g. ad libitum): Standard rabbit diet (Mümmel Z, Plange)
- Water (e.g. ad libitum): water ad libitum
- Acclimation period: Not described
ENVIRONMENTAL CONDITIONS: Temperature, air humidity, Airchanges, and light/dark period were not specified in the report. - Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 ml of undissolved test substance
- Application method: Applied on a gauze piece of 2.5 cm x 2.5 cm, fixated to the skin by Leukoplast non-irritating tape.
- Coverage of exposed skin areas: The entire back of the rabbit was covered in a fitted rubber cover/cloth to prevent evaporation of the test substance.
No vehicle or solvent was used for dissolving or diluting the test substance. - Duration of treatment / exposure:
- 24 hours
- Observation period:
- a total of 72 hours. Observation points at 24 hours after start of exposure (at removal of the gauze piece with the test substance) and after 72 hours.
- Number of animals:
- 6
- Details on study design:
- On each rabbit four contact sites were present:
2 exposure sites with application of the test substance; 1 shaved site and 1 shaved/abrased site
2 untreated sites without application of test substance; 1 shaved site and 1 shaved/abrased site
TEST SITE
- Area of exposure: 2.5 cm X 2.5 cm
- % coverage: not described
- Type of wrap if used: Rubber wrapping
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not described
- Time after start of exposure: 24 h
SCORING SYSTEM: Grading of the skin reactions was performed evaluating the appearance of A) erythema and B) oedema, each on a scale from 0 to 4. The assessment was done comparing the reaction of the treated sites with the untreated sites scoring. The grading and scoring terms are in accord with OECD Guideline no. 404 and EU Method B.4
The score of each animal after 24 and 72 hours was logged for erythema and oedema on the shaved and shaved/abraded sites, respectively. For each animal an index (average score) for the reaction on the shaved or shaved/abraded sites was calculated as the arithmetic mean of the scores obtained at the respective sites.
The group index for the shaved or shaved/abraded skin was calculated as the arithmetic mean of the individual indexes. Finally, the acute skin irritation index of the test substance as an skin irritant was calculated as the combined mean of the group indexes.
Substances with acute skin irritation index below 2 was categorized as mild irritants, indexes between 2 and 5 as medium irritating, and indexes above 6 as very irritating. The categorization was in accord with recommendations from the Verband der Chemischen Industrie e.V., 13.5.1976, Frankfurt/Main, Germany. - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0.17
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: None
- Irritant / corrosive response data:
- See tables below
- Other effects:
- No
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Empfehlung des Verbandes der Chemischen Industrie e.V., 13/05/1976, 6 Frankfurt/Main, Germany.
- Conclusions:
- Small Vinyl Ester is categorized as "not irritating", with an overall irritation score of 0.17.
- Executive summary:
The acute skin irritation/corrosion of Samall Vinyl Ester was tested in 6 albino-rabbits. Exposure for 24 h on shaved and shaved/abraded skin was performed using 0.5 ml of undiluted test substance on 2.5 cm x 2.5 cm gauze pieces covered with a fitted rubber cover, followed by observation of the skin reaction at 24 h and 72 h after start of the exposure test. For control 2 untreated shaved and shaved/abraded sites were observed concomitantly. Scoring of erythema and oedema reactions was performed in accord with current standards for grading of skin reactions. The experimental setup and procedure essentially followed the methods described in EU Methods B.4 (Dermal Irritation/Corrosion) and OECD guideline for Testing of Chemicals no. 404. The overall irritation score was 0.17. Thus, Small vinyl Ester is not a skin irritant.
Reference
Table 1: Results:
|
|
|
24 h |
72 h |
Animal 1 |
Shaved |
Erythema |
0 |
0 |
|
|
Oedema |
0 |
0 |
|
Shaved/Abraded |
Erythema |
2 |
0 |
|
|
Oedema |
0 |
0 |
Animal 2 |
Shaved |
Erythema |
0 |
0 |
|
|
Oedema |
0 |
0 |
|
Shaved/Abraded |
Erythema |
0 |
0 |
|
|
Oedema |
0 |
0 |
Animal 3 |
Shaved |
Erythema |
0 |
0 |
|
|
Oedema |
0 |
0 |
|
Shaved/Abraded |
Erythema |
0 |
0 |
|
|
Oedema |
0 |
0 |
Animal 4 |
Shaved |
Erythema |
0 |
0 |
|
|
Oedema |
0 |
0 |
|
Shaved/Abraded |
Erythema |
1 |
0 |
|
|
Oedema |
0 |
0 |
Animal 5 |
Shaved |
Erythema |
0 |
0 |
|
|
Oedema |
0 |
0 |
|
Shaved/Abraded |
Erythema |
0 |
0 |
|
|
Oedema |
0 |
0 |
Animal 6 |
Shaved |
Erythema |
0 |
0 |
|
|
Oedema |
0 |
0 |
|
Shaved/Abraded |
Erythema |
1 |
0 |
|
|
Oedema |
0 |
0 |
Table 2: Index of the acute skin irritation in shaved and shaved/abraded skin.
Irritation index shaved skin |
Irritation index shaved/abraded skin |
||
Animal No. |
Average Index |
Animal No. |
Average Index |
1 |
0 |
1 |
0.50 |
2 |
0 |
2 |
0.00 |
3 |
0 |
3 |
0.00 |
4 |
0 |
4 |
0.25 |
5 |
0 |
5 |
0.00 |
6 |
0 |
6 |
0.25 |
Average (X1) |
0 |
Average (X2) |
0.17 |
Overall irritation index (X1+ X2) |
0.17 |
|
|
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-03-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 437
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- not signed
- Species:
- other: Cow
- Details on test animals or tissues and environmental conditions:
- Eyes from cattles were used same days as they were slaughtered
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- 1122 mg and 2484 mg
- Duration of treatment / exposure:
- Corneas were pre-incubated for 1 hour minimum at 32 C. Exposure time was 10 minutes. After exposure the cornea was rinsed to remove the test substance, and incubated for 2 hours for opacity measurement. The permeability was measured after 90 minutes incubation with sodium flourescein
- Observation period (in vivo):
- Corneas were incubated for 2 hours after exposure for opacity measurement, and 90 minutes for permeability testing
- Number of animals or in vitro replicates:
- 3 eyes for negative, positive, positive on gauze pacth and the test substance, respectively.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Done after exposure time
- Time after start of exposure:
SCORING SYSTEM: Opacity was measured using an opacitometer (OP-KIT,MC2, Clermont, France)
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- other: Mean Opacity
- Basis:
- mean
- Time point:
- other: 2 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- other: Mean Permeability
- Basis:
- mean
- Time point:
- other: 90 minutes
- Score:
- 0.011
- Max. score:
- 0.015
- Irritant / corrosive response data:
- The In Vitro Irritancy score (IVIS) were calculated to 0.2. According to OECD Guideline 437 a substance has to induce a IVIS more or equal to 55.1 in order to be defined as corrosive or severe irritant. The positive controls induced a IVIS at 147 and 134, respectively, where as the negative control induced a IVIS at 0.0, conclusively the tested substance was similar to the negative control.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Small Vinyl Ester was tested for eye irritating potential and permeability, following OECD Guideline 437. The substance obtained values similar to the negative control, thus Small Vinyl Ester is considered a non irritant.
- Executive summary:
Small Vinyl Ester was tested for eye irritating potential and permeability, following OECD Guideline 437. Data for the negative and positive controls showed validity of the test system. Small Vinyl Ester obtained values for both Opacity and Permeability, similar to the negative control. The obtained In Vitro Irritancy Score (IVIS) was 0.2, whereas according to the OECD Guideline 437, a substance has to obtain a IVIS at 55.1 or more in order to be defined as a corrosive or irritant. In can therefore be concluded that Small Vinyl Ester is not an irritant when tested according to OECD Guideline 437.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The substance did not show acid-/alkaline reserve capacity, cf. IUCLID section 4.23.
Skin irritation: The substance was tested for skin irritation potential, essentially following the methods described in EU Methods B.4 (Dermal Irritation/Corrosion) and OECD guideline for Testing of Chemicals no. 404.
Eye irritation: The substance was tested for eye irritating potential and permeability, following OECD Guideline 437. Data for the negative and positive controls showed validity of the test system.
Justification for classification or non-classification
Based on the findings of reliable skin irritation and eye irritation studies conducted on the substance, classification of the substance is not justified.
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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