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EC number: - | 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:
- 1998-07-01 - 1998-12-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- EEC Methods for the determination of toxicity. Annex to Directive 92/69/EEC (Official Journal No. L383A. 29.12.92). Part B, Method B. 1. Acute toxicity (oral)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- OECD Guideline for Testing of Chemicals No. 401 "Acute Oral Toxicity". Adopted 24 February 1987
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Fatty acids, C16-18 (even numbered), reaction products with tetraethylenepentamine
- Molecular formula:
- not applicable (UVCB substance)
- IUPAC Name:
- Fatty acids, C16-18 (even numbered), reaction products with tetraethylenepentamine
- Test material form:
- other: granules
- Details on test material:
- - Substance type: pure substance
- Storage condition of test material: room temperature
- Appearance: Pale yellow granules
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CD rats of Sprague-Dawley origin (Hsd:Sprague-Dawley(CD))
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan U.K. Ltd, Bicester, Oxon, England.
- Age at study initiation: 5-7 weeks
- Weight at study initiation: 99 - 116 g
- Fasting period before study: yes, overnight prior to and for approximately 4 hours after dosing
- Housing: Rats were allocated without conscious bias to cages within the treatment group and housed in groups of five rats of the same sex in metal cages with wire mesh floors in Building R14 Room 6.
- Diet (e.g. ad libitum): standard laboratory rodent diet (Special Diet Services RM1(E) SQC expanded pellet) ad libitum
- Water (e.g. ad libitum): drinking water ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 24 °C
- Humidity (%): 38 - 61%
- Photoperiod (hrs dark / hrs light): Lighting was controlled by means of a time switch to provide 12 hours of artificial light (0700 - 1900 hours) in each 24-hour period.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1% w/v aqueous methylcellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20% w/v
- Amount of vehicle (if gavage): total volume 10 ml/kg bw
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw (test item) / 10 ml/kg bw (formulated dosing solution)
DOSAGE PREPARATION (if unusual): The test substance was prepared on the day of dosing. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 / sex / dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Cages of rats were checked al least twice daily for any mortalities. Animals were obseived soon after dosing and at frequent intervals for the remainder of Day 1. On subsequent days, animals in the main study were observed once in the morning and again at the end of the experimental day (with the exception of Day 15 - morning only). The bodyweight of each rat in the main study was recorded on Days 1 (prior to dosing), 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortalities observed
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortalities observed
- Mortality:
- There were no deaths following a single oral dose of the test item to a group of ten rats (five males and five females) at a dosage of 2000 mg/kg bodyweight.
- Clinical signs:
- other: Piloerection was observed in all rats soon after dosing. This sign persisted and was accompanied in all animals later during the study by hunched posture, and in one female by abnormal respiration. There were no other clinical signs and recovery of rats w
- Gross pathology:
- No macroscopic abnormalities were observed for animals killed at study termination on Day 15.
Any other information on results incl. tables
PRELIMINARY STUDY
In the absence of precise toxicological information and to establish a dosing regime for the main study, a group of two rats (one male and one female) was dosed at 1000 mg/kg bodyweight. Clinical signs in these animals included piloerection, hunched posture, waddling/unsteady gait, lethargy and abnormal respiration. Bodyweight gain was considered to be satisfactory for studies of this nature and duration and no abnormalities were observed at study termination on Day 8. On the basis of results from this preliminary study, 2000 mg/kg was selected as a suitable dose level for the main study.
Table 1: Signs of reaction to treatment
Signs |
No. of rats showing signs |
|||
Preliminary study (1000 mg/kg) |
Main study (2000 mg/kg) |
|||
Male |
Female |
Male |
Female |
|
Piloerection |
1 |
1 |
5 |
5 |
Hunched posture |
1 |
1 |
5 |
5 |
Waddling / unsteady gait |
1 |
1 |
0 |
0 |
Lethargy |
1 |
1 |
0 |
0 |
Abnormal respiration* |
1 |
0 |
0 |
1 |
* Characterized by gasping / noisy respiration
Table 2: Individual and group mean bodyweights (g)
Dose (mg/kg) |
Sex |
Animal number |
Bodyweight (g) at Day |
||
1* |
8 |
15 |
|||
2000 |
Male |
11 |
99 |
155 |
207 |
12 |
105 |
178 |
234 |
||
13 |
108 |
173 |
228 |
||
14 |
108 |
180 |
234 |
||
15 |
108 |
171 |
225 |
||
Mean |
106 |
171 |
226 |
||
Female |
16 |
111 |
158 |
187 |
|
17 |
116 |
179 |
205 |
||
18 |
111 |
155 |
188 |
||
19 |
103 |
143 |
173 |
||
20 |
100 |
151 |
173 |
||
Mean |
108 |
157 |
185 |
* Prior to dosing
Table 3: Individual body weight changes
Dose (mg(kg) |
Sex |
Animal number |
Bodyweight gains (g) at Day |
|
8 |
15 |
|||
2000 |
Male |
11 |
56 |
52 |
12 |
73 |
56 |
||
13 |
65 |
55 |
||
14 |
72 |
54 |
||
15 |
63 |
54 |
||
Female |
16 |
47 |
29 |
|
17 |
63 |
26 |
||
18 |
44 |
33 |
||
19 |
40 |
30 |
||
20 |
51 |
22 |
Applicant's summary and conclusion
- Interpretation of results:
- other: EU-GHS criteria not met
- Conclusions:
- The study was conducted under GLP according to OECD guideline 401 on the registered substance itself. The method is to be considered scientifically reasonable with no deficiencies in documentation. Hence, the results can be considered as reliable to assess the acute oral toxicity in rats.
There were no deaths following a single oral dose of Octadecanoic acid, reaction products with tetraethylenepentamine, to a group of ten rats (five males and five females) at a dosage of 2000 mg/kg bodyweight.
On the grounds of the obtained results, Octadecanoic acid, reaction products with tetraethylenepentamine, can be classified to the following categories:
- category 5 / unclassified – according to the Globally Harmonized System (GHS),
- agents which are beyond categorization – according to the Regulation (EC) No. 1272/2008 - Executive summary:
This study was performed to assess the acute oral toxicity of Octadecanoic acid, reaction products with tetraethylenepentamine to the rat. The method followed was that described in:
- EEC Methods for the determination of toxicity. Annex to Directive 92/69/EEC (Official Journal No. L383A. 29.12.92). Part B, Method B. 1. Acute toxicity (oral).
- OECD Guideline for Testing of Chemicals No. 401 "Acute Oral Toxicity". Adopted 24 February 1987.
A group of ten fasted rats (five males and five females) received a single oral gavage dose of the test substance, formulated in 1% w/v aqueous methylcellulose and administered at a dose level of 2000 mg/kg bodyweight. This dosage was selected on the basis of results from a preliminary study. All animals were killed and examined macroscopically on Day 15, the end of the observation period.
Clinical signs of reaction to treatment were confined to piloerection and hunched posture, seen in all rats with abnormal respiration also seen in one female. There were no other signs of reaction to treatment and recovery was complete in all animals by Day 4.
All animals were considered to have achieved satisfactory bodyweight gains throughout the study.
No macroscopic abnormalities were observed for animals killed at study termination on Day 15.
The acute lethal oral dose to rats of Octadecanoic acid, reaction products with tetraethylenepentamine was demonstrated to be greater than 2000 mg/kg bodyweight.
Octadecanoic acid, reaction products with tetraethylenepentamine will not require labelling with the risk phrase R22 "Harmful if swallowed", in accordance with Commission Directive 93/21/EEC. Similarly, it can be classified to the following categories:
- category 5 / unclassified – according to the Globally Harmonized System (GHS),
- agents which are beyond categorization – according to the Regulation (EC) No. 1272/2008
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