Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 946-979-6 | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15-Feb-2005 to 15-Apr-2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- Commission Directive 2004/73/EC, B.4. “Acute Toxicity: Dermal Irritation/Corrosion”, April 29, 2004.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted April 24, 2002
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,2',2''-nitrilotriethanol
- EC Number:
- 203-049-8
- EC Name:
- 2,2',2''-nitrilotriethanol
- Cas Number:
- 102-71-6
- Molecular formula:
- C6H15NO3
- IUPAC Name:
- 2,2',2''-nitrilotriethanol
- Reference substance name:
- 2-(2-aminoethoxy)ethanol
- EC Number:
- 213-195-4
- EC Name:
- 2-(2-aminoethoxy)ethanol
- Cas Number:
- 929-06-6
- Molecular formula:
- C4H11NO2
- IUPAC Name:
- 2-(2-aminoethoxy)ethanol
- Reference substance name:
- Heptanoic acid
- EC Number:
- 203-838-7
- EC Name:
- Heptanoic acid
- Cas Number:
- 111-14-8
- Molecular formula:
- C7H14O2
- IUPAC Name:
- heptanoic acid
- Reference substance name:
- Isooctanoic acid
- EC Number:
- 246-617-0
- EC Name:
- Isooctanoic acid
- Cas Number:
- 25103-52-0
- Molecular formula:
- C8H16O2
- IUPAC Name:
- isooctanoic acid
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- water
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- New Zealand White Rabbit, SPF
Recognized by the international guidelines as the recommended test system.
Source: Charles River Laboratories France, BP 0109, F-69592 L’Arbresle.
Number of animals per test: 3 (Animals of both sexes were used).
Age at treatment: 11 weeks (male and females).
Identification: By unique cage number and corresponding ear number.
Acclimatization: Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.
Allocation: Male No. 1, Female Nos. 2 and 3.
Conditions: Standard Laboratory Conditions: Air-conditioned with ranges for room temperature 17 23 °C, relative humidity 30-70 % and approximately 10 15 air changes per hour. Room temperature and humidity were monitored continuously and values outside of these ranges may have occasionally occurred, usually following room cleaning. These transient variations are considered not to have any influence on the study and, therefore, these data are not reported but are retained at RCC. The animals were provided with an automatically controlled light cycle of 12 hours light and 12 hours dark. Music was played during the daytime light period.
Accommodation : Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks (RCC Ltd, Füllinsdorf) and haysticks 4642 (batch no. 38/04, Provimi Kliba AG) were provided for gnawing.
Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch nos. 68/04 and 93/04) provided by Provimi Kliba AG, CH-4303 Kaiseraugst. Results of analysis for contami¬nants are archived at RCC Ltd.
Water: Community tap water from Füllinsdorf, ad libitum. Results of bacteriological, chemical and contaminant analyses are ar-chived at RCC Ltd.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST ITEM PREPARATION:
0.5 mL (per animal) of the test item was measured with a syringe and applied undiluted.
The pH of the test item was measured by the Sponsor and was found to between 9 and 9.5.
According to Commission Directive 2004/73/EC, B.4. and OECD Guidelines 404, a test item needs not to be tested if the pH-value is less than 2 or greater than 11.5, owing to its predictable corrosive properties. - Duration of treatment / exposure:
- The duration of treatment was 4 hours.
- Observation period:
- Observation of local findings: Throughout 7 days after treatment.
Viability/Mortality: Daily from acclimatization of the animals to the termination of test.
Clinical signs: Daily from acclimatization of the animals to the termination of test.
Body weights: At start of acclimatization, on the day of application and at termination of observation. - Number of animals:
- three animals
- Details on study design:
- TREATMENT:
Four to five days before treatment, the left flank was (or both flanks were) clipped with an electric clipper, exposing an area of approximately 100 cm2 (10 cm x 10 cm). The skin of the animals was examined one day before treatment, and regrown fur of all animals was clipped again. Due to strong hair growth, the right flank of animal no. 1 was clipped as well.
Animals with overt signs of skin injury or marked irritation which may have interfered with the interpretation of the results were not used in the test.
On the day of treatment, 0.5 mL of the test item was placed on a surgical gauze patch (2.5 cm x 2.5 cm). This gauze patch was applied to the intact skin of the clipped area. The patch was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape.
The duration of treatment was 4 hours. Then the dressing was removed and the skin was flushed with lukewarm tap water to clean the application site so that any reactions (erythema) were clearly visible at that time.
As it was suspected that the test item might produce irritancy, a single animal (one female) was treated first. As neither a corrosive effect nor a severe irritant effect was observed after the 4-hour exposure, the test was completed using the two remaining animals for an exposure period of four hours.
IRRITATION SCORES:
The skin reaction was assessed according to the numerical scoring system listed in the Commission Directive 2004/73/EC, April 29, 2004, approximately 1, 24, 48 and 72 hours, as well as 7 days after the removal of the dressing, gauze patch and test item.
To allow further examination of the test site animal no. 2 was re-clipped on completion of the 1-hour examination. Animals no. 1 and 3 were re-clipped just after the 72-hour observation.
If evident, corrosive or staining properties of the test item were described and recorded.
TREATMENT OF RESULTS:
Data are summarized in tabular form, showing the irritation scores for erythema and oedema for each individual animal at all observation intervals after patch removal, any lesions, a description of the degree and nature of irritation, corrosion or reversibility, and any other toxic effects observed.
To evaluate the irritation of the test item the mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. An animal is positive when the mean score is 2 or greater. The test is positive for irritation when at least 2 animals are positive for the same endpoint (erythema/eschar or oedema).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- Well-defined erythema were observed in all three animals at the 1-hour reading and persisted as very slight erythema up to 24-hour observation in two animals or 72-hour examination in one animal.
Very slight swelling was noted in all three animals at the 1-hour observation.
No abnormal findings were observed on the treated skin of any animal 7 days after treatment, the end of the observation time.
Neither alterations of the treated skin were observed nor were corrosive effects evident on the skin. - Other effects:
- No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
No staining produced by the test item of the treated skin was observed.
Any other information on results incl. tables
SKIN IRRITATION SCORES - INDIVIDUAL VALUES
Animal Number | Sex | Evaluation Interval* | Erythema | Oedema |
1 2 3 |
M F F |
1 hour | 2 2 2 |
1 1 1 |
1 2 3 |
M F F |
24 hours | 1 1 1 |
0 0 0 |
1 2 3 |
M F F |
48 hours | 1 0 0 |
0 0 0 |
1 2 3 |
M F F |
72 hours | 1 0 0 |
0 0 0 |
1 2 3 |
M F F |
7 days | 0 0 0 |
0 0 0 |
* Examinations were performed at the specified times after removal of the dressing.
The body weights of all rabbits were considered to be within the normal range of variability. Body weight in grams:
Animal No. | Sex | First Day of Acclimatization | Day of Treatment | Last Day of Observation |
1 | male | 2129 | 2417 | 2616 |
2 | female | 2043 | 2221 | 2588 |
3 | female | 2020 | 2275 | 2566 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based upon the referred classification criteria (Commission Directive 2001/59/EC of August 2001), the test item is considered to be “not irritating” to rabbit skin.
The test item is not considered to be classified for Skin irrititation/corrosion based on GHS criteria (not classified: not irritating / not Skin Irrit. 3). - Executive summary:
The primary skin irritation potential of the test item was investigated according to OECD test guideline no. 404. The test item was applied by topical semi-occlusive application of 0.5 mL to the intact left or right flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours, as well as 7 days after removal of the dressing.
The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. The mean erythema/eschar score of the three animals was 1.00, 0.33 and 0.33, respectively and the mean oedema score was 0.00 for all three animals, respectively.
The application of the test item to the skin resulted in mild signs of irritation. These included erythema and oedema. These effects were reversible and were no longer evident 7 days after treatment, the end of the observation period for all animals. The test item caused no staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed.
Thus, the test item did not induce significant or irreversible damage to the skin.
Based upon the referred classification criteria (Commission Directive 2001/59/EC of August 2001), the test item is considered to be “not irritating” to rabbit skin.
Based on GHS criteria ( Regulation (EC) No 1272/2008 and GHS of the United Nations (ST/SG/AC.10/30) ) the test item is considered to be “not irritating” to rabbit skin.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.