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EC number: 701-003-6 | CAS number: -
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 March 2016 to 17 May 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- Organization for Economic Co-operation and Development (OECD), OECD Guidelines for Testing of Chemicals, Section 4, Health Effects. No.423, "Acute Oral Toxicity - Acute Toxic Class Method", 2001.
- Deviations:
- yes
- Remarks:
- See "Any other information" for details
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- Commission Regulation (EC) No 440/2008 Part B: Methods for the Determination of Toxicity and other Health Effects; B1 tris: "Acute Oral Toxicity, Acute Toxic Class Method". Official Journal of the European Union No. L142, May 2008, including the most recent amendments.
- Deviations:
- yes
- Remarks:
- See "Any other information" for details
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- United States Environmental Protection Agency (EPA). Health Effects Test Guidelines, OPPTS 870.1100, Acute Oral Toxicity. Office of Prevention, Pesticides and Toxic Items (7101), EPA 712-C-02-190, 2002.
- Deviations:
- yes
- Remarks:
- See "Any other information" for details
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF No 8147
- Version / remarks:
- Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000; including the most recent partial revisions.
- Deviations:
- yes
- Remarks:
- See "Any other information" for details
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Amidation products of C16-18 (even numbered), C18 unsaturated fatty acids esters with 1,1'-iminodipropan-2-ol
- EC Number:
- 701-003-6
- Cas Number:
- 1454803-04-3
- Molecular formula:
- C20H39NO3 to C26H51NO3
- IUPAC Name:
- Amidation products of C16-18 (even numbered), C18 unsaturated fatty acids esters with 1,1'-iminodipropan-2-ol
- Test material form:
- liquid
- Details on test material:
- Identification: MLA-3202
Appearance: Clear amber-red liquid
Purity/Composition: UVCB
Test item storage: At room temperature
Stable under storage conditions until 17 February 2019 (expiry date)
Purity/composition correction factor: No correction factor required
Chemical name (IUPAC), synonym or trade name: Amides, tallow, N,N-bis(2-hydroxypropyl)
CAS Number: 1454803-04-3
Test item handling No specific handling conditions required
Constituent 1
- Specific details on test material used for the study:
- Batch: RC-1045Study specific test item informationPurity/composition correction factor: No correction factor requiredChemical name (IUPAC), synonym or trade name: Amides, tallow, N,N-bis(2-hydroxypropyl)CAS Number: 1454803-04-3Test item handling: No specific handling conditions required
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species: Rat, Wistar strain Crl:WI (Han) (outbred, SPF-Quality). Recognized by international guidelines as the recommended test system (e.g. OECD, EC). Source: Charles River Deutschland, Sulzfeld, Germany. Number of animals: 9 Females (nulliparous and non-pregnant). Age and body weight: Young adult animals (approx. 8-10 weeks old) were selected. Body weight variation did not exceed +/- 20% of the sex mean. Identification: Earmark and tail mark Health inspection: At least prior to dosing. It was ensured that the animals were healthy and without any abnormality that might have affected the study integrity.Animal Husbandry Conditions: Environmental controls for the animal room were set to maintain 18 to 24°C, a relative humidity of 40 to 70%, at least 10 air changes/hour, and a 12-hour light/12-hour dark cycle. Any variations to these conditions were maintained in the raw data and had no effect on the outcome of the study. Accommodation: Group housing of maximally 3 animals per cage in labeled Makrolon cages (MIV type; height 18 cm.) containing sterilized sawdust as bedding material (Lignocel S 8-15, JRS - J.Rettenmaier & Söhne GmbH + CO. KG, Rosenberg, Germany) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom). Acclimatization period was at least 5 days before start of treatment under laboratory conditions. Diet: Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany). Water: Free access to tap water. Diet, water, bedding and cage enrichment evaluation for contaminants and/or nutrients was performed according to facility standard procedures. There were no findings that could interfere with the study.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The toxicity of the test item was assessed by stepwise treatment of groups of females. The first group was treated at a dose level of 2000 mg/kg. The absence or presence of mortality of animals dosed at one step determined the next step, based on the test procedure defined in the guidelines. The onset, duration and severity of the signs of toxicity were taken into account for determination of the time interval between the dose groups.
- Doses:
- Single dosage on Day 1.
- No. of animals per sex per dose:
- 3 animals per group
- Control animals:
- no
- Details on study design:
- Treatment Method: Oral gavage, using plastic feeding tubes. The test item were stirred on a magnetic stirrer during dosing. Fasting: Animals were deprived of food overnight prior to dosing and until 3-4 hours after administration of the test item. Water was available ad libitum. Frequency: Single dosage on Day 1. Dose level (volume): 2000 mg/kg (2.13 mL/kg) body weight. 5000 mg/kg (5.32 mL/kg) body weight. No correction was made for the purity of the test item.Observations Mortality/Viability: Twice daily. Body weights: Days 1 (pre-administration), 8 and 15. Clinical signs: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15. The signs were graded according to fixed scales and the time of onset, degree and duration were recorded: Maximum grade 4: grading slight (1) to very severe (4) Maximum grade 3: grading slight (1) to severe (3) Maximum grade 1: presence is scored (1). Necropsy: At the end of the observation period, all animals were sacrificed by oxygen/carbon dioxide procedure and subjected to necropsy. Descriptions of all internal macroscopic abnormalities were recorded.
- Statistics:
- No statistical analysis was performed.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred at 2000 and 5000 mg/kg body weight.
- Clinical signs:
- Hunched posture was seen for all animals on Day 1 and for one animal dosed at 2000 mg/kg on Days 2 and 3 also. Piloerection was seen for the majority of animals on Day 1. Two females dosed at 5000 mg/kg showed abnormal licking on Day 2.
- Body weight:
- The body weight gain shown by the animals over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain.
- Gross pathology:
- Isolated reddish foci on the thymus were found at macroscopic post mortem examination of one female dosed at 2000 mg/kg. Macroscopic post mortem examination of the other animals at termination did not reveal any abnormalities.
- Other findings:
- Incidental findings included an accessory lobe to the right median lobe of the liver for one female dosed at 2000 mg/kg. This finding is occasionally seen among rats of this age and strain and was therefore considered not related to treatment.
Any other information on results incl. tables
Mortality data
TEST DAY | 1 | 1 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 |
HOURS AFTER TREATMENT | 0 | 2 | 4 |
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|
|
FEMALES 2000 MG/KG FEMALES 2000 MG/KG FEMALES 5000 MG/KG FEMALES 5000 MG/KG | - - - - | - - - - | - - - - | - - - - | - - - - | - - - - | - - - - | - - - - | - - - - | - - - - | - - - - | - - - - | - - - - | - - - - | - - - - | - - - - | - - - - |
Clinical signs
TEST DAY | MAX GRADE | 1 | 1 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 |
HOURS AFTER TREATMENT | 0 | 2 | 4 |
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|
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| |
FEMALES 2000 MG/KG | ||||||||||||||||||
ANIMAL 1 Posture Hunched posture Skin / fur Piloerection |
(1)
(1) |
1
- |
1
1 |
1
1 |
-
- |
-
- |
-
- |
-
- |
-
- |
-
- |
-
- |
-
- |
-
- |
-
- |
-
- |
-
- |
-
- |
-
- |
ANIMAL 2 Posture Hunched posture Skin / fur Piloerection |
(1)
(1) |
1
- |
1
1 |
1
1 |
-
- |
-
- |
-
- |
-
- |
-
- |
-
- |
-
- |
-
- |
-
- |
-
- |
-
- |
-
- |
-
- |
-
- |
ANIMAL 3 Posture Hunched posture Skin / fur Piloerection |
(1)
(1) |
1
- |
1
1 |
1
1 |
1
- |
1
- |
-
- |
-
- |
-
- |
-
- |
-
- |
-
- |
-
- |
-
- |
-
- |
-
- |
-
- |
-
- |
FEMALES 2000 MG/KG | ||||||||||||||||||
ANIMAL 4 Posture Hunched posture |
(1) |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
ANIMAL 5 Posture Hunched posture |
(1) |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
ANIMAL 6 Posture Hunched posture |
(1) |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
FEMALES 5000 MG/KG | ||||||||||||||||||
ANIMAL 7 Posture Hunched posture Skin / fur Piloerection |
(1)
(1) |
-
- |
1
1 |
1
1 |
-
- |
-
- |
-
- |
-
- |
-
- |
-
- |
-
- |
-
- |
-
- |
-
- |
-
- |
-
- |
-
- |
-
- |
FEMALES 5000 MG/KG | ||||||||||||||||||
ANIMAL 8 Behaviour Abnormal licking Posture Hunched posture Skin / fur Piloerection |
(1)
(1)
(1)
|
-
-
- |
-
1
1 |
-
-
- |
1
-
- |
-
-
- |
-
-
- |
-
-
- |
-
-
- |
-
-
- |
-
-
- |
-
-
- |
-
-
- |
-
-
- |
-
-
- |
-
-
- |
-
-
- |
-
-
- |
ANIMAL 9 Behaviour Abnormal licking Posture Hunched posture Skin / fur Piloerection |
(1)
(1)
(1) |
-
-
- |
-
1
1 |
-
-
- |
1
-
- |
-
-
- |
-
-
- |
-
-
- |
-
-
- |
-
-
- |
-
-
- |
-
-
- |
-
-
- |
-
-
- |
-
-
- |
-
-
- |
-
-
- |
-
-
- |
. Observation not performed. Sufficient data was available to warrant the study integrity.
Body weights
SEX/DOSE LEVEL | ANIMAL | DAY 1 | DAY 8 | DAY 15 |
FEMALES 2000 MG/KG |
1 2 3
MEAN ST. DEV. N |
150 164 165
160 8 3 |
171 202 191
188 16 3 |
193 211 208
204 10 3 |
FEMALES 2000 MG/KG |
4 5 6
MEAN ST. DEV. N |
158 167 178
168 10 3 |
182 197 206
195 12 3 |
192 206 216
205 12 3 |
FEMALES 5000 MG/KG |
7
MEAN ST. DEV. N |
167
167 -- 1 |
199
199 -- 1 |
207
207 -- 1 |
FEMALES 5000 MG/KG |
8 9
MEAN ST. DEV. N |
174 171
173 2 2 |
195 190
193 4 2 |
200 203
202 2 2 |
Macroscopic findings
ANIMAL | ORGAN | FINDING | DAY OF DEATH |
FEMALES 2000 MG/KG | |||
1 |
| No findings noted | Scheduled necropsy Day 15 after treatment |
2 |
| No findings noted | Scheduled necropsy Day 15 after treatment |
3 | Liver | Right medial lobe: accessory liver | Scheduled necropsy Day 15 after treatment |
FEMALES 2000 MG/KG | |||
4 | Thymus | Focus/foci, isolated, reddish | Scheduled necropsy Day 15 after treatment |
5 |
| No findings noted | Scheduled necropsy Day 15 after treatment |
6 |
| No findings noted | Scheduled necropsy Day 15 after treatment |
FEMALES 5000 MG/KG | |||
7 |
| No findings noted | Scheduled necropsy Day 15 after treatment |
FEMALES 5000 MG/KG | |||
8 |
| No findings noted | Scheduled necropsy Day 15 after treatment |
9 |
| No findings noted | Scheduled necropsy Day 15 after treatment |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 value of MLA-3202 in Wistar rats was established to exceed 5000 mg/kg body weight.According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.
- Executive summary:
The study was performed to assess the acute oral toxicity of MLA-3202 in the rat (Acute Toxic Class Method). The study was carried out based on the guidelines described in:
-OECD No.423 (2001) "Acute Oral Toxicity, Acute Toxic Class Method"
-Commission Regulation (EC) No 440/2008, B1 tris: “Acute Oral Toxicity, Acute Toxic Class Method”
-EPA, OPPTS 870.1100 (2002), "Acute Oral Toxicity"
-JMAFF Guidelines (2000), including the most recent revisions.
Initially, MLA-3202 was administered by oral gavage to three female Wistar rats at 2000 mg/kg body weight. In a stepwise procedure, one additional group of three females was dosed at 2000 mg/kg, one female at 5000 mg/kg and one group of two females at 5000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15).
No mortality occurred.
Hunched posture was seen for all animals on Day 1 and for one animal dosed at 2000 mg/kg on Days 2 and 3 also. Piloerection was seen for the majority of animals on Day 1. Two females dosed at 5000 mg/kg showed abnormal licking on Day 2.
The body weight gain shown by the animals over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain.
Isolated reddish foci on the thymus were found at macroscopic post mortem examination of one female dosed at 2000 mg/kg. No other test item related abnormalities were noted in any of the remaining animals.
The oral LD50 value of MLA-3202 in Wistar rats was established to exceed 5000 mg/kg body weight.
According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.
Based on these results, MLA-3202 does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).
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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