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EC number: 262-108-6 | CAS number: 60209-82-7
- 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
Skin irritation (OECD 404): not irritating (based on read-across from CAS 10233-13-3)
Eye irritation: not irritating (based on read-across from CAS 59130-69-7 and CAS 110-27-0 and in vitro studies of the target substance in a weight of evidence approach)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 - 18 Mar 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Limited information on test substance and test protocol, occlusive conditions.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- limited information on test substance and test protocol, occlusive conditions
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: New Zealand
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Jegard
- Weight at study initiation: 1.84 kg
- Acclimation period: 4 days - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated sites served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): pure undiluted substance - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
Reading time points: 1, 24, 48, 72 h and 7 days - Number of animals:
- 3 (male)
- Details on study design:
- Patch Method according to Selon J.O. R.F. ler Fevrier, 1982
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Directive 67/548/CEE - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for grouping of substances and read-across
There are no data available on the in vivo skin and eye irritation potential of isodecyl pivalate (CAS 60209-82-7). In order to fulfil the standard information requirements set out in Annex VIII, 8.1 and 8.2, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances was conducted.
In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across).
Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006 whereby substances may be predicted as similar provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity.
Overview of irritation / corrosion
CAS |
Chemical name |
Molecular weight |
Skin irritation |
Eye irritation |
60209-82-7 (a) |
Isodecyl pivalate |
ca. 242 |
WoE: |
WoE: |
10233-13-3 (b) |
Isopropyl laurate |
ca. 242 |
Experimental result: |
-- |
110-27-0 |
Isopropyl myristate |
270.46 |
Experimental result: |
Experimental result: |
59130-69-7 |
Hexadecyl 2-ethylhexanoate |
368.63 |
Experimental result: |
Experimental result: |
(a) Substances subject to the REACh Phase-in registration deadline of 31 May 2013 are indicated in bold font.
(b) Substances that are either already registered under REACh or not subject to the REACh Phase-in registration deadline of 31 May 2013 are indicated in normal font. Lack of data for a given endpoint is indicated by “--“.
The above mentioned substances are considered to be similar on the basis of the structural similar properties and/or activities. The available endpoint information is used to predict the same endpoints for isodecyl pivalate (CAS 60209-82-7). A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).
Discussion
Skin irritation
CAS 60209-82-7
In a human skin patch test performed under GCP conditions, 0.02 mL isodecyl pivalate (CAS 60209-82-7) was applied to the skin of the arm or scapular area of 10 volunteers and covered with an occlusive dressing for 48 hours (Supporting, Stearinerie, 1997). The skin irritation reaction was scored 30 minutes and 24 hours after patch removal. No skin irritation reactions were seen in any volunteer at any time point.
CAS 10233-13-3
A primary dermal irritation study was performed with isopropyl laurate (CAS 10233-13-3) according to OECD Guideline 404 (Key, Stearinerie, 1991). The shaved skin of three rabbits was exposed to 0.5 mL unchanged test material for 4 hours under occlusive conditions. The rabbits were observed for 7 days. Slight oedema and erythema (score 1, respectively) was observed in 1/3 animals from the 1-hr reading time point until the 48-hr reading time point. The effects had cleared completely within 72 hours. 2/3 animals were free of any skin irritation.
Eye irritation
CAS 60209-82-7
Two in vitro eye irritation studies were performed using isodecyl pivalate (CAS 60209-82-7) (WoE, Stearinerie, 1997). The Hen’s Egg Test Chorioallantoic Membrane (HET-CAM) assay was performed on 6 fertile, 10 days old, white Leghorn eggs. 6 eggs were exposed to the test substance for 20 seconds and the irritation was scored 30 sec, and 2 and 5 min after exposure ended. The IP-CAM score was 0, indicating that the test substance is not corrosive. The negative and positive controls were valid.
A cytotoxicity assay with rabbit cornea (SIRC) fibroblasts, following the MTT assay, was performed (WoE, Stearinerie, 1997). The SIRC cells were first seeded into Transwell inserts and then placed in tissue culture plate wells with culture medium. Following an incubation period of 48 hrs at 37 ⁰C, the Transwell inserts were transferred into second cluster plates and incubated with a 1% solution of the test substance for 30 min, 1 hr and 4 hrs. To measure the cell viability, the solution was incubated with MTT dye for 2-3 hrs. Finally, the absorbance of the solution was measured with a spectrophotometer at 570 nm. The cell viability was 96, 100 and 72% for the 30-min-, 1-hr- and 4-hr reading time points, respectively. The mean cytotoxicity index (MCI) was 2.4 and the ocular irritation index (IOeq) 6.0, indicating that the substance is slightly irritating.
CAS 110-27-0
An acute eye irritation study was performed with isopropyl myristate (CAS 110-27-0) according to a protocol similar to OECD 405, on 3 New Zealand White rabbits (WoE, Croda, 1977). One eye of the rabbits was exposed to 0.1 mL of the undiluted test substance and scored for eye reactions. The animals were observed for 7 days and scoring was performed 24, 48 and 72 h and 4 and 7 days after application. Conjunctival redness (score 1) was observed in 2/3 animals at the 24-h reading time point. The effect was fully reversible within 48 hours. No other eye irritation effects were observed.
CAS 59130-69-7
The potential of hexadecyl 2-ethylhexanoate (CAS 59130-69-7) to cause eye irritation was evaluated in a GLP study performed according to OECD guideline 405 (WoE, BASF, 1991). 0.1 mL hexadecyl 2-ethylhexanoate was instilled into the eyes of three Kleinrussen rabbits; the test substance was removed by washing with water after 24 hrs. 3/3 rabbits had slight conjunctiva (score 1) at the 1-hour reading time point. The mean scores after 24, 48 and 72 h for conjunctivae were 0.33, 0.33 and 0.67 respectively, while the mean scores for cornea, iris and chemosis were 0 for 3/3 rabbits. Therefore, hexadecyl 2-ethylhexanoate was found to be not irritating to eyes.
Conclusions for irritation / corrosion
The results of the skin irritation studies performed with the source and target substance (Key, Stearinerie, 1991; Supporting, Stearinerie, 1997) indicate that isodecyl pivalate (CAS 60209-82-7) will not cause skin irritation. The results of the in vitro studies of the target substance (WoE, Stearinerie, 1997) and in vivo eye irritation studies with the source substances (WoE, Croda, 1977;WoE, BASF, 1991) indicate that isodecyl pivalate will not cause eye irritation.
Justification for classification or non-classification
Based on substance-specific data and read-across from the structurally similar substances, the available data on skin and eye irritation do not meet the classification criteria according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification.
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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