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EC number: 946-398-8 | 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09 September 2015 to 30 September 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Tall Oil Fatty Acids, compounds with 2-(2-aminoethoxy) ethanol
- Molecular formula:
- Too complex
- IUPAC Name:
- Tall Oil Fatty Acids, compounds with 2-(2-aminoethoxy) ethanol
- Test material form:
- liquid
- Details on test material:
- - Appearance/ Physical State: light brown slightly viscous liquid
- Storage conditions: room temperature, in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- ANIMALS AND ANIMAL HUSBANDRY
- Five male and five femal Wistar (RccHan: WIST) strain rats were supplied by Envigo RMS (UK) Limited, Oxon, UK.
- The animals were randomly allocated to cages on receipt.
- Female animals were nulliparous and non-pregnant.
- After an acclimatisation period of at least 5 days, animals were selected at random and given a number unique within the study by indelible ink-marking on the tail and recording of the number on a cage card.
- Animals weighed at least 200 g and were 8 to 12 weeks of age at the start of the study.
- The weight variation did not exceed ± 20 % of the mean weight for each sex.
- Animals were housed in suspended solid-floor polypropylene cages furnished with woodflakes.
- The initial two animals were housed individually throughout the study.
- The further group of eight animals (four male and four female) were housed individually during the 24 hour exposure period and in groups of four, by sex, for the remainder of the study.
- Free access to mains drinking water and food (2014C Teklad Global Rodent diet supplied by Envigo RMS (UK) Limited, Oxon, UK) was allowed throughout the study.
- The diet, drinking water and bedding were routinely analysed and were considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study.
- Temperature and relative humidity were set to achieve limits of 19 to 25 °C and 30 to 70 % respectively.
- The rate of air exchange was at least fifteen changes per hour.
- Lighting was controlled by a time switch to give 12 hours continuous light (06:00 to 18:00) and 12 hours darkness.
- Animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- PROCEDURE
- On the day before treatment, the back and flanks of each animal were clipped free of hair.
- One male and one female rat were initially treated with the test item at a dose level of 2000 mg/kg.
- The calculated volume (2.06 mL/kg; specific gravity 0.975) of test item, as received, was applied as evenly as possible to an area of shorn skin (approximately 10 % of the total body surface area) using a graduated syringe.
- A piece of surgical guaze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage.
- The animals were caged individually throughout the study.
- Shortly after dosing the dressings were examined to ensure they were securely in place.
- After the 24 hour contact period the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with arachis oil to remove any residual test item.
- As no mortalities were noted, a further group of animals (four males and four females) were similarly treated with test item at a dose level of 2000 mg/kg bw .
- After the 24 hour contact period, the bandages were carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with arachis oil BP to remove any residual test item.
- The fanimals were returned to group housing for the remainder of the test period.
- Animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days.
- After removal of the dressings and subsequently once daily for 14 days, the test sites were examined for evidence of primary irritation and scored according to the scheme attached. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- TEST FORMULATION AND EXPERIMENTAL PREPARATION
- The test item was weighed out according to each animal's individual body weight and applied undiluted as supplied.
- The absorption of the test item was not determined. - Statistics:
- - Data evaluations included the relationsip, if any, between exposure of the animal to the test item and the incidence and severity of all abnormalities including behavioural and clinical observations, gross lesions, body weight changes, mortality and other toxicological effects.
- Using the mortality data obtained, and estimate of the acture dermal median lethal dose (LD50) of the test item was made.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animal deaths took place.
- Clinical signs:
- No signs of systemic toxicity were observed.
- Body weight:
- - Individual body weights and body weight changes are shown in Table 4 (attached).
- Animals showed expected gains in body weight over the observation period except for one female, which showed no gain in body weight during the first week with expected gain in body weight during the second week. - Gross pathology:
- - Individual necropsy findings are given in Table 5 (attached).
- No abnormalities were noted at necropsy. - Other findings:
- DERMAL REACTIONS
- Individual dermal reactions are shown in Tables 2 and 3 (attached).
- There were no signs of dermal irritation at the test site of the initial treated male.
- Very slight erythema, with or without very slight edema, was noted at the test sites of four males and all females. Small superficial scabs and/or crust formation were noted at the test sites of six animals. There were no signs of dermal irritation noted at the test site of the initial treated male.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal toxicity of the test item was assessed in accordance with OECD Guideline 402. The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was considered to be greater than 2000 mg/kg body weight. Therefore, the test item does not meet the criteria for classification.
- Executive summary:
GUIDELINE
OECD Guidelines for the Testing of Chemicals No 402 "Acute Dermal Toxicity" (adopted 24 February 1987) and Method B3 Acute Toxicity (Dermal) of Commission Regulation (EC) No 440/2008.
METHOD
Initially, two animals (one male and one female) were given a single, 24 hour, semi-occluded dermal application of the test item to intact skin at a dose level of 2000 mg/kg bw. Based on the results of the initial test, a further group of eight animals (four males and four females) were treated similarly. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.
RESULTS
Mortality: No animal deaths took place during the study.
Clinical observations: No signs of systemic toxicity were observed.
Dermal irritation: Very slight erythema, with or without very slight edema, was noted at the test sites of four males and all females. Small superficial scabs and/or crust formation were noted at the test sites of six animals. There were no signs of dermal irritation noted at the test site of the initial treated male.
Body weight: Animals showed expected gains in body weight over the observation period except for one female, which showed no gain in body weight during the first week with expected gain in body weight during the second week.
Necropsy: No abnormalities were noted at necropsy.
CONCLUSION
The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was considered to be greater than 2000 mg/kg body weight.
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