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EC number: 939-514-3 | CAS number: 1471312-26-1
- 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:
- 01 - 08 Jun 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions. The exposure was occlusive.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- occlusive exposure
- GLP compliance:
- yes
Test material
- Reference substance name:
- Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters
- IUPAC Name:
- Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters
- Details on test material:
- - Name of test material (as cited in study report): (C12-C13) Alkyl lactate
- Analytical purity: 100% (UVCB)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Padre Antonio, Mariano Comense, Italy
- Weight at study initiation: 2.5 - 3.5 kg
- Housing: the rabbits were caged individually in stainless steel cages (45.0 cm x 50.0 cm x 38.0 cm).
- Diet: standard pellet complete diet (Rieper), ad libitum
- Water: filtered tap water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 01 Jun 1992 To: 08 Jun 1992
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: sesame seed oil
- Controls:
- other: the untreated sites of the same animal served as the control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 g of the solid test substance was mixed with 0.5 mL vehicle to a paste - Duration of treatment / exposure:
- 4 h
- Observation period:
- 7 days
Reading time points: 1, 24, 48 and 72 h - Number of animals:
- 6 males
- Details on study design:
- TEST SITE
- Area of exposure: approximately 24 hours before the test an area on the dorsal side and flank of approximately 24.0 cm² was clipped and shaved. An area of approximately 20 cm² on the right flank was used for the application of the test substance.
- Type of wrap if used: the test site was covered with a square gauze pad (2.5 x 2.5 cm) fixed to adhesive tape (Hansamed strips). The pad was fixed to the skin with strips of hypoallergenic tape (Blenderm 3M) and the trunk wrapped with rubberised cloth (Acrylastic Beyersdorf AG Hamburg).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the remains of the test substance were removed by washing the skin site with a pad soaked in distilled water.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: mean after 24, 48 and 72 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48-72 h
- Remarks on result:
- other: 2/6 animals: very slight erythema at the 1 h reading time point
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of all 6 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritant / corrosive response data:
- 2/6 rabbits had very slight erythema from the 1 h reading time point, which persisted until the 24 h reading time point in 1/6, and until the 48 h reading time point in 1/6 rabbits, respectively. All observed skin irritation effects were completely reversible within 72 hours. No edema was observed at any reading time point.
- Other effects:
- No other local or systemic effects were reported.
Any other information on results incl. tables
Table 1. Individual skin irritation scores
Observation time |
Rabbit no. |
|||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
|||||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
1 h |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
24 h |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
48 h |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Mean value 24 + 48 + 72 h |
0.67 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.33 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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