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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
Oral LD50 (OECD 401), mouse, LD50 >5000 mg/kg bw
Dermal LD50 (OECD 402), rat, LD50 >2000 mg/kg bw (RA from CAS 149144-85-4)
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given. No data on test material purity and limited details on test animals and experimental conditions.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- no data on test material purity and limited details on test animals and experimental conditions
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 20 g - Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 males or females
- Control animals:
- no
- Details on study design:
- - Other examinations performed: clinical signs
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities occurred during the study period.
- Clinical signs:
- other: No clinical signs and no behavioural abnormalities were observed after treatment with the test substance.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The available information comprises an adequate and reliable studies (Klimisch score 2) from the target substance and from a reference substance with similar structure and intrinsic properties. Read-across is justified based on common functional group(s), common precursors/breakdown products, similarities in PC/ECO/TOX properties. The selected studies are thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- March - April 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Morini - S. Polo d'Enza (RE), Italy
- Weight at study initiation: 170 - 230 g
- Fasting period before study: not mentioned
- Housing: in groups of 5 per sex per cage (polycarbonate, dimensions 425x266x180 mm)
- Diet: standard pellet complete diet ad libitum
- Water: filtered tap water ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2
- Humidity (%): 55 +/- 15
- Air changes (per hr): 25
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 29-MAR-1993 To: 12-APR-1993 - Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: no data
- % coverage: no data
- Type of wrap if used: no data
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: no data
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 mL/kg - Duration of exposure:
- no data
- Doses:
- 2000 m/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality: daily in the working week (5 out of 7 days)
Clinical symptoms (including evaluation of body functions, tegumentary apparatus, mucosae conditions, respiratory activity, somatomotor activity and sensorium conditions): daily in the working week (5 out of 7 days)
Body weight: before the experiment, at day 7 and 14
- Necropsy of survivors performed: yes - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: Signs of toxicity related to dose levels: None
- Gross pathology:
- No pathological symptoms were observed, nothing abnormal was found.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The available information comprises an adequate and reliable study (Klimisch score 2 due to read-across) from a reference substance with similar structure and intrinsic properties. Read-across is justified based on common functional group(s), common precursors/breakdown products, similarities in PC/ECO/TOX properties. The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.
Additional information
Justification for grouping of substances and read-across
There are only limited data available on acute toxicity of Diisooctadecyl malate (CAS 67763-18-2). In order to fulfil the standard information requirements set out in Annex VII and VIII, 8.5, 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 on acute toxicity
CAS |
Chemical name |
Molecular weight [g/mol] |
Acute toxicity Oral |
Acute toxicity Inhalation |
Acute toxicity Dermal |
67763-18-2 (a) |
Diisooctadecyl malate |
639.06 |
Experimental result: LD50 >5000 mg/kg bw (mouse)
RA: CAS 149144-85-4 |
-- |
RA: CAS 149144-85-4 |
149144-85-4 (b) |
Di C12-13 Alkyl Malate
|
470.73/498.78 |
Experimental result: LD50 >5000 mg/kg bw (rat) |
-- |
Experimental result: LD50 >2000 mg/kg bw (rat) |
(a) The substance subject to registration is indicated in bold font.
(b) Reference (read-across) substances 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 Diisooctadecyl malate (CAS 67763-18-2). A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).
Discussion
Beside an acute oral toxicity study with Diisooctadecyl malate (CAS 67763-18-2) no further reliable data on acute toxicity is available with Diisooctadecyl malate (CAS 67763-18-2). Therefore, read across from the structurally analogue substance Di C12-13 Alkyl Malate (CAS 149144-85-4) was applied.
Acute toxicity: oral
CAS 67763-18-2
The acute oral toxicity study with Diisooctadecyl malate (CAS 67763-18-2) was conducted equivalent or similar to OECD TG 401 and in compliance with GLP (Dufour, 1988a). In this limit test five NMRI mice of unknown gender were administered one dose of 5000 mg/kg bw of the test substance (CAS 67763-18-2) via oral gavage. The acute oral LD50 value was calculated to be greater than 5000 mg/kg bw. No signs of clinical toxicity were reported, no mortalities occurred during the observation period. Based on the study results and according to EU classification criteria, the test substance is not to be classified.
CAS 149144-85-4
The acute oral toxicity study with Di C12-13 Alkyl Malate (CAS 149144-85-4) was conducted according to OECD TG 401 and in compliance with GLP (Biffi, 1992). The test substance was administered at a limit dose of 5000 mg/kg by using a stomach tube. There were no cases of mortality during the study period. In summary, 3/10 rats showed piloerection from day 1 to 3. The body weight gain was normal during the study period. At the necropsy all animals showed slightly reddened gastric mucosa. The LD50 value was calculated to be greater than 5000 mg/kg bw and he test substance was found to be non-toxic under the experimental conditions.
Based on the above study results with Diisooctadecyl malate (CAS 67763-18-2) and the read across substance Di C12-13 Alkyl Malate (CAS 149144-85-4) and according to EU classification criteria, the test substance Diisooctadecyl malate is not to be classified.
Acute toxicity: dermal
CAS 149144-85-4
The test for acute dermal toxicity was performed on a group of ten rats (5 male and 5 female) according to EU Method B.3 and in compliance with GLP (Biffi, 1993a). The test substance Di C12-13 Alkyl Malate (CAS 149144-85-4) was administered at a limit dose of 2000 mg/kg bw by dermal application. During the study period no mortality occurred. Furthermore, no clinical symptoms were observed during the study period and the body weight gain was normal for the used species. At necropsy the animals showed no pathological symptoms. Therefore, the LD50 value was calculated to be greater than 2000 mg/kg bw and the test substance was found to be non-toxic under the experimental conditions. Based on the results of the study and according to EU classification criteria, the test substance is not to be classified.
Acute toxicity: inhalation - Waiving
The substance has very low vapour pressure, so the potential for the generation of inhalable forms is low, also the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur. Furthermore the results of laboratory animal studies show low acute oral and dermal toxicity for the substance. This intrinsic property/toxicity potential can be extrapolated to acute inhalative route administration.
Justification for selection of acute toxicity – oral 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 acute toxicity – dermal endpoint
Hazard assessment is conducted by means of read-across from structural analogues. All available studies are adequate and reliable based on the identified similarities in structure and intrinsic properties between source and target substances and overall quality assessment.
Justification for classification or non-classification
According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint". Since the analogue concept is applied to Diisooctadecyl malate (CAS 67763-18-2), data will be generated from information on reference source substance(s) to avoid unnecessary animal testing. Additionally, once the analogue read-across concept is applied, substances will be classified and labelled on this basis.
Therefore, based on the acute oral toxicity study and the analogue read-across approach, the available data on acute toxicity 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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