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EC number: 267-041-6 | CAS number: 67763-18-2
- 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 (similar to OECD 404), rabbit: not irritating
Eye irritation (similar to OECD 405), rabbit: 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no analytical purity and clinical signs reported; environmental condition (temperature range) differs from the temperature recommended in the appropriate OECD guideline
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, Prouzel, France
- Age at study initiation: adult animals
- Weight at study initiation: 2200 - 3500 g
- Housing: the animals were housed individually in polystyrene cages.
- Diet: granulated diet 112 C (U.A.R., Villemoisson-sur-Orge, France), ad libitum
- Water: filtered tap water, ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL - Duration of treatment / exposure:
- Initial test: 3 min, 1 and 4 h
Confirmatory test: 3 min and 4 h - Observation period:
- 7 days
Reading time points: 1, 24, 48 and 72 h and 4 days - Number of animals:
- 3 males (main test)
1 male (initial test) - Details on study design:
- TEST SITE
- Area of exposure: 6 cm² on one site of the dorsal/flank area
- Type of wrap if used: The test item was introduced under a patch which was secured in position with a hypoallergenic medical plaster.
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean after 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicablereversibility: not applicable
- Irritant / corrosive response data:
- In an initial test slight erythema formation (grade 1) was noted in one animal 1 h after patch removal and remained 48 h after patch removal and was fully reversible within 72 h. No edema formation was observed. Slight erythema formation (grade 1) was noted in 3/3 animals 1 h after patch removal and remained in all animals 24 h after patch removal. Erythema formation was fully reversible within 48 h in 2/3 animals and 4 days in 1/3 animals. No edema formation was recorded in any animal.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
Reference
Table 1: Summary of individual skin irritation after 3 min and 4 h exposure in one rabbit (initial test)
Observation time |
Rabbit no. |
|
1 |
||
Erythema |
Edema |
|
1 h |
1 |
0 |
24 h |
1 |
0 |
48 h |
1 |
0 |
72 h |
0 |
0 |
Mean value 24+48+72 h |
0.67 |
0 |
Table 2: Summary of individual skin irritation scores after 4 h exposure (main test)
Observation time |
Rabbit no. |
|||||
1 |
2 |
3 |
||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
1 h |
1 |
0 |
1 |
0 |
1 |
0 |
24 h |
1 |
0 |
1 |
0 |
1 |
0 |
48 h |
1 |
0 |
0 |
0 |
0 |
0 |
72 h |
1 |
0 |
0 |
0 |
0 |
0 |
Mean value 24+48+72 h |
1 |
0 |
0.33 |
0 |
0.33 |
0 |
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no analytical purity and clinical signs reported; environmental condition (temperature range) differs from the temperature recommended in the appropriate OECD guideline
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, Prouzel, France
- Age at study initiation: adult animals
- Weight at study initiation: 2200 - 3500 g
- Housing: the animals were housed individually in polystyrene cages.
- Diet: granulated diet 112 C (U.A.R., Villemoisson-sur-Orge, France), ad libitum
- Water: filtered tap water, ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 3 days
Reading time points: 1, 24, 48 and 72 h - Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- SCORING SYSTEM: Draize scoring system
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean after 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- Neither corneal nor iris effects were noted after application with the test material in all animals during the study period. Chemosis and conjunctivae (redness) effects (grade 1) were recorded in 3/3 animals 1 h after application with the test material. These effects were fully reversible within 24 h in 3/3 animals.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- 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
Discussion
Reliable data on skin and eye irritation is available with Diisooctadecyl malate (CAS 67763-18-2).
Skin irritation
The skin irritation properties of Diisooctadecyl malate (CAS 67763-18-2) were tested in a reliable in vivo skin irritation study performed similar or equivalent to OECD TG 404 (Jouffrey, 1995a). In the study 0.5 mL test substance was applied to the shaved skin of one New Zealand White rabbits in an initial test for 3 min and 4 hours using a semi-occlusive dressing. As only slight erythema formation (grade 1) was recorded 1 - 48 h after application of the test material (being fully reversible within 72 h) the same animal and two additional animals were exposed to 0.5 mL of the test material for 3 min and 4 h. The treated skin of animals exposed to the test material for 4 h was observed and evaluated at 1, 24, 48 and 72 h and 4 days post-application. Slight erythema formation (grade 1) was noted in 3/3 animals 1 h after patch removal and remained in all animals 24 h after patch removal. Erythema formation was fully reversible within 48 h in 2/3 animals and 4 days in 1/3 animals. No edema formation was recorded in any animal. Thus, the test substance is considered to be non-irritating under the conditions of the test.
In the skin irritation study with Diisooctadecyl malate (CAS 67763-18-2) performed according to OECD TG 404 (Dufour, 1988b) three New Zealand White rabbits of unknown gender were treated with the test material and the treated skin was observed and evaluated for 72 h. After the observation period one moderate (grade 2) and one slight (grade 1) erythema was found after treatment of the animals. In addition, a very slight edema (grade 1) was observed, which was fully reversible at the 72 h observation time point, whereas one erythema (grade 1) was still present 72 h after exposure. No erythema and edema scores for each individual animal are reported. No test material purity and only limited information on the study design are available. Moreover, as effects were still present at the 72 h reading time point reversibility cannot be assessed. Thus, the available information is insufficient for assessment.
Eye irritation
The eye irritation properties of Diisooctadecyl malate (CAS 67763-18-2) have been investigated in an in vivo study performed similar or equivalent to OECD TG 405 (Jouffrey, 1995b). For the assessment of the eye irritation properties 0.1 mL of the test substance was instilled in the eye of three male New Zealand White rabbits. The untreated eye of each animal served as control. The eyes were examined and the changes were graded according to the Draize scoring system 1, 24, 48 and 72 hours post-application. Neither corneal nor iris effects were noted after application with the test material in all animals during the study period. Chemosis and conjunctivae (redness) effects (grade 1) were recorded in 3/3 animals 1 h after application of the test material. These effects were fully reversible within 24 h in 3 3 animals. Based on the results of the study the test material is considered to be non-irritating to eyes.
Justification for selection of skin irritation / corrosion endpoint:
The selected study is the most adequate and reliable study based on overall quality assessment (refer to the endpoint discussion for further details).
Justification for selection of eye irritation endpoint:
The reliable and comparable OECD Guideline study was choosen.
Justification for classification or non-classification
The available data on irritation/corrosion of the registered substance do not meet the criteria for classification according to Regulation (EC) No. 1272/2008, and are therefore conclusive but not sufficient for classification.
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