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EC number: 700-672-1 | CAS number: 70226-26-5
- 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
Acute toxicity: Oral LD50 (rat, m/f): > 20,000 mg/kg bw (FDA, 1959)
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: National guideline study with acceptable restrictions.
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the safety of chemicals in foods, drugs and cosmetics" by the Staff of the Division of Pharmacology, FDA, 1959
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Zucht Winkelmann, Paderborn, Germany
- Weight at study initiation: 120-145 g (males), 115-145 g (females)
- Fasting period before study: 16 h
- Housing: single caging
- Diet: standard laboratory diet (Ssniff/Intermast), ad libitum.
- Water: ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 45-55
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 50%
- Amount of vehicle: 20 and 40 mL/kg bw
MAXIMUM DOSE VOLUME APPLIED: 40 mL/kg bw
DOSAGE PREPARATION: The test substance was diluted to a final concentration of 50% in olive oil.
- Rationale for the selection of the starting dose: Based on a range-finding study (not further information), doses of 10 and 20 g/kg bw were selected for the determination of the LD50 value. - Doses:
- 10,000 and 20,000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- other: not required
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations and weighing: animals were observed for clinical signs 20 min and 1, 3, 24 and 48 h and 7 days after administration. Individual body weights were determined at Day 0 (study initiation) and at the end of the observation period (Day 7).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight and gross necropsy - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 20 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 10,000 mg/kg bw: 0/5 males and 0/5 females died.
20,000 mg/kg bw: 1/5 males and 1/5 females were found dead at 48 h post treatment. - Clinical signs:
- other: At 10,000 and 20,000 mg/kg bw, piloerection, slight staggering and ataxia were observed 1 and 3 h after administration (no further information on number of animals). The effects were reversible within 24 h.
- Gross pathology:
- No changes were observed at gross necropsy of dead and sacrificed animals of the examined organs (brain, lung, heart, stomach, intestines, liver, spleen, kidneys, serous membrane/vessels, lymph nodes and gonads).
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
Reference
Table 1.Results of acute oral toxicity experiment.
Does [mg/kg bw] |
Mortalities [No. of animals/No. in group] |
Time of death (post-treatment) |
Mortality [%] |
Clinical signs / Duration |
Males |
||||
10,000 |
0/5 |
- |
0 |
Staggering, ataxia, piloerection / 1-3 h post-dose |
20,000 |
1/5 |
48 h |
20 |
Staggering, ataxia, piloerection / 1-3 h post-dose |
Females |
||||
10,000 |
0/5 |
- |
0 |
Staggering, ataxia, piloerection / 1-3 h post-dose |
20,000 |
1/5 |
48 h |
20 |
Staggering, ataxia, piloerection / 1-3 h post-dose |
Table 2. Body weight and body weight gain.
Animal number |
Body weight on Day 0 [g] |
Body weight on Day 7 [g] |
Body weight gain [%] |
Males (10,000 mg/kg bw) |
|||
1 |
130 |
155 |
19 |
2 |
135 |
160 |
19 |
3 |
120 |
135 |
13 |
4 |
140 |
150 |
7 |
5 |
145 |
165 |
14 |
Mean |
134 |
153 |
14 |
|
|||
Females (10,000 mg/kg bw) |
|||
1 |
120 |
145 |
21 |
2 |
115 |
130 |
13 |
3 |
130 |
155 |
19 |
4 |
120 |
145 |
21 |
5 |
140 |
160 |
14 |
Mean |
125 |
147 |
18 |
|
|||
Males (20,000 mg/kg bw) |
|||
1 |
140 |
- (dead) |
- |
2 |
145 |
155 |
7 |
3 |
135 |
120 |
-11 |
4 |
140 |
145 |
4 |
5 |
145 |
155 |
7 |
Mean* |
141.25 |
143.75 |
2 |
|
|||
Females (20,000 mg/kg bw) |
|||
1 |
135 |
160 |
19 |
2 |
135 |
150 |
11 |
3 |
145 |
105 |
-28 |
4 |
140 |
- (dead) |
- |
5 |
145 |
160 |
10 |
Mean* |
140 |
143.74 |
3 |
*Calculations based on surviving animals
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The available information comprises an adequate and reliable study (Klimisch score 2) from a reference substance with similar structure and intrinsic properties. Read-across is justified based on common functional group(s), common precursors/breakdown products and similarities in PC/ECO/TOX properties (refer to endpoint discussion for further details).
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Oral
There are no data available on the acute oral toxicity of Reaction product of lauric acid and oxybis(propanediol) (List No. 700-672-1). In order 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 read-across from the structurally related surrogate substance 2,3-dihydroxyproypl laurate (CAS No. 142-18-7) was conducted.
Reaction product of lauric acid and oxybis(propanediol) mainly consists of diglycerol monoesters with lauric acid (C12). Therefore, available data on the acute oral toxicity of the structural surrogate, 2,3-dihydroxyproypl laurate (CAS No. 142-18-7), a glycerol monoester with lauric acid (C12), was considered for read-across and assessment was conducted based on an analogue approach.
The acute toxicity of 2,3-dihydroxyproypl laurate after oral administration was investigated in a test conducted according to the “Appraisal of the safety of chemicals in foods, drugs and cosmetics, FDA, 1959” (Sterner, 1977). Groups of 5 male and 5 female Wistar rats per dose were given 10,000 or 20,000 mg/kg bw of the test substance by gavage and the animals were observed for a period of 7 days following administration.
During the study period, 1/5 males and 1/5 females died in the high-dose group 48 h after administration. Clinical signs including slight staggering, ataxia and piloerection were observed 1 and 3 h post-dose in several animals (not further specified) being reversible within 24 h. At 20,000 mg/kg bw, the average body weight gain was reduced in both females and males due to strongly decreased body weight of 1 animal in each group. Gross necropsy of dead and sacrificed animals did not reveal any changes of the examined organs.
Therefore, the oral LD50 for male and female rats was considered to be greater than 20,000 mg/kg bw.
Justification for selection of acute toxicity – oral endpoint
Hazard assessment is conducted by means of read-across from a structural analogue. The selected study is the most adequate and reliable study based on the identified similarities in structure and intrinsic properties between source and target substance and overall quality assessment (refer to the endpoint discussion for further details).
Justification for classification or non-classification
Based on read-across from a surrogate substance following an analogue approach, the available data on acute toxicity of Reaction product of lauric acid and oxybis(propanediol) (List No. 700-672-1) do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and the data 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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