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EC number: 268-776-5 | CAS number: 68140-14-7
- 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 oral toxicity data are available for the submission substance (DTO_DETA) supported by read-across data on the components reaction products of AAI_DETA and rosins. VII of the REACH Regulation as the submission substance is classified as a skin corrosive.
No acute inhalation toxicity data are available on the submission substance; data are not required according to Column 2 of Annex
No acute dermal toxicity data are available on the submission substance; data are not required according to Column 2 of Annex VII of the REACH Regulation as the submission substance is classified as a skin corrosive. Read-across data are available for the component rosins.
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:
- 01 to 28 April 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: the test material (tall oil reaction products with diethylenetriamine) was provided by Baker Hughes Ltd., no batch number was available
- Expiration date of the lot/batch: 31 January 2016
- Purity test date: not supplied; purity >95%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark
- Stability under test conditions: assumed stable for the study duration
- Solubility and stability of the test substance in the solvent/vehicle: arachis oil BP was used because the test item was not soluble in distilled water - Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain/sex: Wistar (RccHan:WIST), female
- Source: Harlan Laboratories UK Ltd., Oxon, UK
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 162 - 186 g (the body weight variation did not exceed ±20% of the body weight of the initially dosed animal).
- Fasting period before study: overnight immediately before dosing
- Housing: in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): 2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK, ad libitum
- Water (e.g. ad libitum): mains drinking water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 °C
- Humidity (%): 30-70%
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
IN-LIFE DATES: From: 01 April 2015 To: 28 April 2015 - Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Remarks:
- for 300 mg/kg bw dose level only
- Details on oral exposure:
- For the purpose of the 2000 mg/kg bw dose level the test item was used as supplied. The specific gravity was determined to be 0.950 and used to calculate the appropriate dose volume for the required dose level. For the purpose of the 300 mg/kg dose level the test item was freshly prepared, as required, as a solution in arachis oil BP. Arachis oil BP was used because the test item did not dissolve/suspend in distilled water.
The dose volume for the 300 mg/kg bw dose was 10 mL/kg bw with a concentration of 30 mg/mL. The dose volume for the 2000 mg/kg bw was 2.11 mL/kg bw. The volume administered to each animal was calculated according to the fasted body weight at the time of dosing.
The test item was formulated within 2 hours of being applied to the test system. It was assumed that the formulation was stable for this duration.
No analysis was conducted to determine the homogeneity, concentration or stability of the test item formulation. This is an exception with regard to GLP and has been reflected in the GLP compliance statement. - Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 300 mg/kg bw: 1 female
2000 mg/kg bw: 5 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made 30 minutes, 1, 2, and 4 hours after dosing and then daily for 14 days. Morbidity and mortality checks were made twice daily. Individual body weights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.
- Necropsy of survivors performed: yes; external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. - Statistics:
- Not required.
- Preliminary study:
- Not applicable
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities occured.
- Clinical signs:
- other: No signs of systemic toxicity were noted during the observation period.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- No other findings reported.
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The LD50 was estimated to be >2000 mg/kg bw in female rats and classification according to CLP is not required.
- Executive summary:
The acute oral toxicity of 'tall oil reaction products with diethylenetriamine' was investigated in female Wistar rats, according to OECD 420. Following a sighting test in single rats at dose levels of 300 mg/kg bw and 2000 mg/kg bw, a further group of four females was given a single oral dose of the test item at a dose level of 2000 mg/kg bw. Clinical signs and body weight development were monitored for 14 days. All animals were subjected to gross necropsy at study termination.
No mortalities occurred and there were no clinical signs of toxicity. All animals showed expected body weight gains during the observation period. No abnormalities were noted at necropsy. Therefore, under the conditions of the study, the LD50 was estimated to be greater than 2000 mg/kg bw and classification according to CLP is not required.
Reference
No further information available.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- OECD guideline and GLP-compliant study with no deviations
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is classified as corrosive to the skin
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is classified as corrosive to the skin
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute oral toxicity
A GLP and guideline-compliant (OECD 420) acute oral toxicity study with the target substance DTO_DETA is available. The acute oral LD50 in rats was >2000 mg/kg bw, therefore classification according to CLP is not required. Data for the components rosin and AAI_DETA also show low acute oral toxicity.
Acute dermal toxicity
No studies are available with DTO_DETA and none are required as the substance is classified as a skin corrosive. AAI_DETA are similarly classified as corrosive. Acute dermal toxicity studies with rosin show low toxicity (acute dermal LD50 in rats > 2000 mg/kg bw).
Acute inhalation toxicity
No studies are available with DTO_DETA and none are required as the substance is classified as a skin corrosive.
Justification for classification or non-classification
Based on the available data for the submission substance DTO_DETA, classification for acute toxicity according to the CLP Regulation is not required.
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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