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EC number: 283-740-9 | CAS number: 84712-50-5
- 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
In the key skin irritation study, conducted according to a protocol similar to OECD TG 404 and in compliance with GLP, the test substance, Acetic acid, C11-14-isoalkyl esters, C13-rich, was reported to be not irritating to intact or abraded skin of rabbits (Biosearch, 1979).
In the key eye irritation study, conducted according to a protocol similar to OECD TG 405 and in compliance with GLP, the test substance, Acetic acid, C11-14-isoalkyl esters, C13-rich, was reported to be not irritating to rabbit eyes (Biosearch, 1979).
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:
- 10 July 1979 to 13 July 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Limited details reported in materials and methods section.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Expiration date of the lot/batch: no data
- Purity test date: no data
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: no data
- Stability under test conditions: no data
- Solubility and stability of the test substance in the solvent/vehicle: the test substance was applied undiluted
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: no data
- Preliminary purification step (if any): no data - Species:
- rabbit
- Strain:
- other: albino rabbits
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 males and 3 females
- Details on study design:
- TEST SITE
- Area of exposure: One side of the animals' backs was abraded and the other side was left intact.
- % coverage: a wide area
- Type of wrap if used: Gauze patches were placed over the treated area and an impervious material was wrapped around the trunk of the animals to hold the patches in place.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 24 hours
OBSERVATION TIME POINTS
24 and 72 hours
SCORING SYSTEM:
- Method of calculation: Draize - Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- Abraded skin
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Remarks:
- Abraded skin
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Remarks:
- Abraded skin
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Remarks:
- Abraded skin
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- No other effects were recorded.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the skin irritation study, conducted according to a protocol similar to OECD TG 404 and in compliance with GLP, the test substance was reported to be not irritating to intact or abraded skin of rabbits.
Reference
Table 1: Individual and average scores for erythema and eschar formation
Erythema |
Reading (hours) |
Rabbit No. 1 |
Rabbit No. 2 |
Rabbit No. 3 |
Rabbit No. 4 |
Rabbit No. 5 |
Rabbit No. 6 |
Average |
Intact skin |
24 |
0 |
1 |
1 |
1 |
1 |
0 |
0.67 |
Intact skin |
72 |
0 |
0 |
0 |
0 |
0 |
0 |
0.00 |
Abraded skin |
24 |
0 |
1 |
1 |
1 |
1 |
0 |
0.67 |
Abraded skin |
72 |
0 |
0 |
0 |
0 |
0 |
0 |
0.00 |
Table 2: Individual and average scores for oedema formation
Oedema |
Reading (hours) |
Rabbit No. 1 |
Rabbit No. 2 |
Rabbit No. 3 |
Rabbit No. 4 |
Rabbit No. 5 |
Rabbit No. 6 |
Average |
Intact skin |
24 |
0 |
1 |
1 |
1 |
0 |
0 |
0.67 |
Intact skin |
72 |
0 |
0 |
0 |
0 |
0 |
0 |
0.00 |
Abraded skin |
24 |
0 |
1 |
1 |
1 |
1 |
0 |
0.67 |
Abraded skin |
72 |
0 |
0 |
0 |
0 |
0 |
0 |
0.00 |
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:
- 9 July 1979 to 16 July 1979
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Expiration date of the lot/batch: no data
- Purity test date: no data
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: no data
- Stability under test conditions: no data
- Solubility and stability of the test substance in the solvent/vehicle: The test substance was used as supplied. - Species:
- rabbit
- Strain:
- other: albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: young adult
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- single instillation
- Observation period (in vivo):
- The treated eyes were examined at 1, 2, 3, 5 and 7 days following instillation of the test material into the eyes.
- Number of animals or in vitro replicates:
- 6 rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test material was not washed from the eyes.
- Time after start of exposure: not applicable
SCORING SYSTEM: According to the "Illustrated Guide for Grading Eye Irritation by Hazardous Substances".
TOOL USED TO ASSESS SCORE: no data - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 1, 2, 4, 5, 6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- The average ocular irritation score was 0.7 on day 1 post-instillation, then 0.0 for the rest of the observation period.
- Other effects:
- No other effects were observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the eye irritation study, conducted according to a protocol similar to OECD TG 405 and in compliance with GLP, the test substance, Acetic acid, C11-14-isoalkyl esters, C13-rich, was reported to be not irritating to rabbit eyes.
Reference
Table 1: Individual daily scores.
Rabbit number |
Irritation parameter |
Readings day 1 |
Readings day 2 |
Readings day 3 |
Readings day 5 |
Readings day 7 |
1 |
Corneal opacity |
0 |
0 |
0 |
0 |
0 |
1 |
Iris |
0 |
0 |
0 |
0 |
0 |
1 |
Conjunctivae |
0 |
0 |
0 |
0 |
0 |
1 |
Chemosis |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
2 |
Corneal opacity |
0 |
0 |
0 |
0 |
0 |
2 |
Iris |
0 |
0 |
0 |
0 |
0 |
2 |
Conjunctivae |
0 |
0 |
0 |
0 |
0 |
2 |
Chemosis |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
3 |
Corneal opacity |
0 |
0 |
0 |
0 |
0 |
3 |
Iris |
0 |
0 |
0 |
0 |
0 |
3 |
Conjunctivae |
1 |
0 |
0 |
0 |
0 |
3 |
Chemosis |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
4 |
Corneal opacity |
0 |
0 |
0 |
0 |
0 |
4 |
Iris |
0 |
0 |
0 |
0 |
0 |
4 |
Conjunctivae |
0 |
0 |
0 |
0 |
0 |
4 |
Chemosis |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
5 |
Corneal opacity |
0 |
0 |
0 |
0 |
0 |
5 |
Iris |
0 |
0 |
0 |
0 |
0 |
5 |
Conjunctivae (discharge) |
1 |
0 |
0 |
0 |
0 |
5 |
Chemosis |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
6 |
Corneal opacity |
0 |
0 |
0 |
0 |
0 |
6 |
Iris |
0 |
0 |
0 |
0 |
0 |
6 |
Conjunctivae |
0 |
0 |
0 |
0 |
0 |
6 |
Chemosis |
0 |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In the key skin irritation study, conducted according to a protocol similar to OECD TG 404 and in compliance with GLP, the test substance, Acetic acid, C11-14-isoalkyl esters, C13-rich, was reported to be not irritating to intact or abraded skin of rabbits (Biosearch, 1979).
Following a 24 -hour occluded topical application of 0.5 g undiluted test material onto the abraded and intact skin of the backs of 3 male and 3 female albino rabbits, the average erythema score at 24 and 72 hours was 0.67 and 0.0, respectively, based on the Draize scoring system. The average oedema scores at 24 hours for intact and abraded skin were 0.50 and 0.67, respectively and 0.0 at 72 hours. The treated skin area appeared normal by 72 hours. No other effects were reported.
An insult patch test/ photosensitisation study in human subjects was also available, in which the irritating, fatiguing and sensitising properties of Acetic acid, C11-14-isoalkyl esters, C13-rich were investigated (Biosearch, 1979). Based on the results obtained, it was concluded that the test substance was not a primary skin irritant or a fatiguing agent. No sensitisation reactions were noted. Exposure to UV-A light does not appear to initiate or increase the incidence or severity of irritation, fatigue or sensitisation.
In the key eye irritation study, conducted according to a protocol similar to OECD TG 405 and in compliance with GLP, the test substance, Acetic acid, C11-14-isoalkyl esters, C13-rich, was reported to be not irritating to rabbit eyes (Biosearch, 1979).
Following a single instillation of 0.1 g of undiluted test material into the right eye of six albino rabbits, the average ocular irritation score was 0.7 at 24 hours and 0.0 at 48 and 72 hours. Only one animal had mean conjunctival score of 0.33 at 24, 48 and 72 hours based on "Illustrated Guide for Grading Eye Irritation by Hazardous Substances". No corneal opacity, iritis or chemosis were reported in any of the test animals. No other effects were reported.
Justification for classification or non-classification
Based on the available data for Acetic acid, C11-14-isoalkyl esters, C13-rich, no classification is required for skin or eye irritation according to Regulation (EC) No. 1272/2008.
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