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EC number: 939-459-5 | CAS number: 1471311-24-6
- 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:
- From 23rd December 1998 to 25th February 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction products of tryglycerides, C8-C18 (even numbered) and C18-unsaturated, glycerine and ethylene oxide
- EC Number:
- 939-459-5
- Cas Number:
- 1471311-24-6
- Molecular formula:
- Not applicable (a generic molecular formula can not be provided for this specific UVCB substance)
- IUPAC Name:
- Reaction products of tryglycerides, C8-C18 (even numbered) and C18-unsaturated, glycerine and ethylene oxide
- Details on test material:
- - Physical state: pale yellow liquid
- Storage condition of test material: The test substance was stored at room temperature in the dark.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: B & K Universal G.J., S.L.
- Age at study initiation: 10-12 weeks old
- Weight at study initiation: 2.5-2.7 kg
- Housing: The rabbits were housed individually in stainless steel cages (48 x 59 x 37 cm) with a grille floor, placed on racks.
- Diet (e.g. ad libitum): standard rabbit diet UAR 112, ad libitum.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-18 ºC
- Humidity (%): 55 ± 10%
- Photoperiod (hrs dark / hrs light): 12-hour light and 12-hour dark cycle per day.
IN-LIFE DATES: From: 21st December 1998 To: 15th January 1999
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 60 minutes, 24, 48 and 72 hours after the end of the exposure period
- Number of animals:
- Three
- Details on study design:
- TEST SITE
- Area of exposure: One square test zone, measuring approximately 6 cm2.
- Type of wrap if used: The substance was placed on 2.5 x 2.5 cm squares of surgical gauze and applied to the test area. The patches were held close to the body using strips of adhesive tape. A strip of gauze was wrapped around the trunk of the animal in order to hold the patches in place. The gauze was fixed to the body using additional adhesive tape.
SCORING SYSTEM:
Erythema and eschar formation:
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema to slight eschar formation 4
Edema formation:
No edema 0
Very slight edema (barely perceptible) 1
Slight edema 2
Moderate edema 3
Severe edema 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24-72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24-72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Approximately 60 minutes after the patches were removed, well-defined erythema (grade 2) was observed in all animals. This lesion was accompanied by very slight edema (grade 1) in all of the animals.
After 24 hours, two of the animals presented very slight erythema (grade 1).
However, after 48 hours, only two animals continued to present very slight erythema (grade 1).
After 72 hours, no dermal lesions were observed in any animal. - Other effects:
- The behaviour and physical condition of the rabbits were normal throughout the study.
Any other information on results incl. tables
Table 1: Primary skin irritation test
Animal |
Reaction |
60 min |
24 h |
48 h |
72 h |
1 |
Erythema |
2 |
1 |
1 |
0 |
Edema |
1 |
0 |
0 |
0 |
|
2 |
Erythema |
2 |
1 |
1 |
0 |
Edema |
1 |
0 |
0 |
0 |
|
3 |
Erythema |
2 |
0 |
0 |
0 |
Edema |
1 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is considered to be non-irritant to the skin.
- Executive summary:
The degree of skin initation caused by the test substance was detemined after it was applied to shaved rabbit skin, under a semi-occlusive patch, and left for 4 hours. The study was conducted according to EU method B.4 and OECD guideline 404.
Approximately 60 minutes after the patches were removed, well-defined erythema (grade 2) was observed in all of the animals. This lesion was accompanied by very slight edema (grade 1) in all of the animals.
After 24 hours, two of the animals presented very slight erythema (grade 1)
However, after 48 hours, very slight erythema (grade 1) was observed in only two animals.
After 72 hours, no dermal alterations were observed in any of the animals.
The mean etythema and edema scores for the substance, at 24, 48 and 72 hours after application, were 0.44 and 0.00 respectively.
The substance is considered to be non-irritant to the skin.
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