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EC number: 261-521-9 | CAS number: 58958-60-4
- 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
Eye irritation (OECD 405): not irritating
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:
- 8 - 16 Mar 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions. Few details on animal husbandry were given and the analytical purity was not stated.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted Apr 2002
- Deviations:
- yes
- Remarks:
- few details on animal husbandry given, analytical purity not stated
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.390 kg (no further details given) - Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required, untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 7 d
Reading time points: 1, 24, 48 and 72 h, and 4, 5, 6 and 7 days - Number of animals:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test material was removed with absorbant paper moistened with distilled water
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 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:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- Slight or well-defined erythema (score 1 or 2) was observed in 3/3 animals from 1 h post-application. At the 24 h reading time point, 2/3 animals had well-defined (score 2) and 1/3 slight erythema (score 1). Slight eythema persisted in 2/3 rabbits until Day 5 and in 1/3 until Day 4. At the 1-hour reading time point 1/3 animals had slight edema (score 2) and 1/3 animals had very slight edema (score 1). In both animals very slight edema (score 1) was noted at the 24-hour reading time point, while the effect had cleared within 48 hours. The erythema and edema had cleared completely by the 6 day-reading time point. One rabbit had dry skin from Day 2 - 7, while another rabbit had dry skin from Day 4 - 7.
- 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
Table 1: individual skin irritation scores
Observation time |
Rabbit No. |
|||||
|
1 |
2 |
3 |
|||
|
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
1 h |
1 |
2 |
1 |
0 |
2 |
1 |
24 h |
2 |
1 |
1 |
0 |
2 |
1 |
48 h |
1 |
0 |
1 |
0 |
1 |
0 |
72 h |
1 |
0 |
1 |
0 |
1 |
0 |
4 days |
1 |
0 |
1 |
0 |
1 |
0 |
5 days |
1 |
0 |
0 |
0 |
1 |
0 |
6 days |
0 |
0 |
0 |
0 |
0 |
0 |
7 days |
0 |
0 |
0 |
0 |
0 |
0 |
Mean value 24 + 48 + 72 h |
1.33 |
0.33 |
1.00 |
0 |
1.33 |
0.33 |
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:
- 4 - 11 Apr 1972
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given
- Principles of method if other than guideline:
- Draize Testing method (Draize, J.H. et al., J. Pharm. Exp. Ther. 82: 377-390, 1944) as prescribed by the FDA (in The Federal Register 38 No.187 §15000.42, USA)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: albino
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 7 days
Reading time points: at least 24, 48 and 72 h and 7 days (not further specified in the study report) - Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: 2% fluorescein, slit lamp - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: The chemosis score was included in an overall score for conjunctival erythema and swelling
- Irritant / corrosive response data:
- The scores for eye irritation effects (cornea, iris and conjunctival erythema and chemosis) were 0 at all reading time points in 3/3 rabbits.
- Other effects:
- No effects on behavioural patterns or food intake were observed.
- 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)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
CAS 58958-60-4
A skin irritation study was performed with Isooctadecyl pivalate according to a protocol similar to OECD guideline 404 (Evic-Ceba, 1993). The shaved skin of 3 male New Zealand White rabbits was exposed to 0.5 mL undiluted test material for 24 hours under semiocclusive conditions. The skin irritation effects were evaluated 1, 24, 48 and 72 hours, and 4, 5, 6 and 7 days after patch removal. Slight or well-defined erythema (score 1 or 2) was observed in 3/3 animals from 1 h post-application. At the 24-h reading time point, 2/3 animals had well-defined and had 1/3 slight erythema. Slight eythema persisted in 1/3 rabbits until Day 4 and in 2/3 until Day 5. At the 1-hour reading time point 1/3 animals had slight edema (score 2) and 1/3 animals had very slight edema (score 1). In both animals very slight edema was noted at the 24-hour reading time point, while the effect had cleared within 48 hours. The erythema and edema had cleared completely by the 6-day reading time point. The mean erythema scores (over 24, 48 and 72 hours) per animal were 1.33, 1.0 and 1.33, respectively. The mean edema scores (over 24, 48 and 72 hours) per animal were 0.33, 0 and 0.33, respectively. The test substance is not considered to be irritating to the skin.
Eye irritation
CAS 58958-60-4
An acute eye irritation study was performed with Isooctadecyl pivalate, according to the Draize Testing method (Draize, J.H. et al., J. Pharm. Exp. Ther. 82: 377-390, 1944) and as prescribed by the FDA (The Federal Register 38 No.187 §15000.42, USA) (BTL, 1972). 0.1 mL of the test substance was instilled into the eyes of 3 albino rabbits. The animals were observed for 7 days and scoring was performed at least at least 24, 48 and 72 h and 7 days after instillation (the reading time points were not further specified in the study report). The chemosis score was included in an overall score for conjunctival erythema and swelling, which was according to the method specified above. The scores for eye irritation effects (cornea, iris and conjunctival erythema and chemosis) were 0 at all reading time points in 3/3 rabbits. The test substance is not considered to be irritating to the eye.
Justification for classification or non-classification
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.
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