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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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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: inhalation
Administrative data
- 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
- other:
Cross-reference
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint conclusion:
- adverse effect observed (corrosive)
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
- Endpoint conclusion:
- no study available
Skin irritation:
- neat substance: corrosive in rabbits (OECD TG 404, GLP): pure active
substance (99.4% a.i.) applied to the intact skin for 4 hours, 1/3
animals was noted with full thickness destruction of the skin tissue at
the 48- and 72-hour reading, mild to severe and early-onset signs of
irritation in 2/3 animals (reversible in these animals within 14 d)
- 20% aqueous solution: irritating in rabbits (OECD TG 404, GLP):
substance applied to the intact skin for 4 hours, 3/3 animals showed
grade 4 erythema and grade 4 edema (reversible within 21 d)
Eye irritation:
- neat substance corrosive based on results from skin irritation study;
- 20% aqueous solution: irreversible effects to the eye in rabbits (OECD
TG 405, GLP): grade 3 redness and lesions of the iris grade 2 were
observed throughout the study period (72 hours), reversibility was not
observed
- 1% aqueous solution: reversible effects to the eye in rabbits (OECD TG
405, GLP): mean grade 2 redness and chemosis was observed after 24/48/72
hour observation period, reversibility was not observed until 72 hours
Skin irritation
Several tests for the skin irritation/corrosion potential are available for Amines, N-C10-16-alkyltrimethylenedi-, reaction products with chloroacetic acid.
Anhydrous active substance is not produced by the regular manufacturing process; the active substance as manufactured is the 20% aqueous solution.
The 20% a.i. aqueous solution of registration substance was first tested in 3 New Zealand White rabbits, according to EC method B.4 (1984) and OECD guideline 404 (1981). 0.5 mL of the test substance was applied to the intact skin of rabbits under semi-occlusive conditions for 4 hours.
All three rabbits showed severe erythema (grade 4, including moderate ischemic necrosis, moderate incrustation) and severe edema (grade 4). These effects were completely reversible within 21 days after treatment. Thus, the registration substance (20% a.i.) is irritating to the skin.
As the results were on the borderline to corrosive, a further in vitro test with the neat substance was performed.
The skin corrosion of the lyophilised registration substance (100%) was tested in a human skin model in vitro, according to EC method B.40 (2000/33/EC) and OECD guideline 431 (2002). The cells were treated with a dose of 25.0-27.0 mg wetted test item.
After treatment, the absorbance values for the negative control were above the required acceptability criterion of OD ≥ 0.8 for both intervals. The viability of the positive control met the acceptance criterion with ≤30% concerning the 3 minute treatment (29.6%) and the 1 hour interval (6.12%). These criteria validate the test system.
After treatment with the test substance, the relative absorbance values were decreased to 90.6% for the 3 minute treatment but not to <50%. After 1 hour treatment the relative absorbance values were reduced to 55.0% but not to <15%. Therefore, the test item was considered to be non-corrosive in this in vitro test.
At the time of the conduct of the test, a further confirmatory test in vivo was required, thus a dermal irritation study according to OECD guideline 404 was performed with the lyophilised registration substance (99.4% a.i.) in 3 New Zealand white rabbits. The application of the test item to the skin resulted in mild to severe and early-onset signs of irritation such as erythema, edema and scaling. These effects were reversible and were no longer evident in the two surviving animals 14 days after treatment, the end of the observation period for all animals. One animal was noted with dry skin from the 24- to the 72-hour reading as well as with deep necrosis (full thickness destruction of the skin tissue) at the 48- and 72-hour reading. Thereafter, it was sacrificed for ethical reasons. According to the requirements specified by Regulation (EC) No 1272/2008 and GHS-UN, Amines, N-C10-16-alkyltrimethylenedi-, reaction products with chloroacetic acid requires classification for skin corrosion/irritation with classification category 1C, signal word “danger” and the hazard phrase “H314: Causes severe skin burns and eye damage”.
Eye irritation
In accordance with REACH-Regulation (Annex VIII, 8.2.1, column 2) testing of eye irritating properties of the neat substance in vivo does not need to be conducted because the substance is already classified for irreversible effects on the eye based on the outcome of the in vivo skin irritation study ("Causes severe skin burns and eye damage").
However, an in vivo eye irritation study is available with the registration substance (20% aqueous solution) which constitutes the active substance as manufactured.
Diffuse beefy redness and swelling with lids about half closed or more than half closed as well as lesions of the iris grade 2 (no reaction to light, haemorrhage and/or gross destruction) were observed throughout the study period of the eye irritation study. Reversibility was not observed within the observation period of 72 hours. According to the guidelines, absence of the light reflex (iridial response grade 2) which persists for 72 hours is generally not reversible.Thus, according to the requirements specified by regulation (EC) No 1272/2008 and GHS-UN, the registration substance has to be classified in Category 1, irreversible effects on the eye.
A further study according to OECD TG 405 is available with a 1% aqueous solution of the registration substance. Reversible effects on the iris were observed 24 hours after treament (grade 1 in one animal). Conjunctival redness and chemosis were observed at the 24/48/72 h observation with the following grades for animals 1 to 3: redness: 2, 1.67 and 2, respectively and chemosis: 2, 2 and 1.67, respectively. The observation period lasted only 72 hours. However, it can be assumed that the effect are reversible because the grades of conjunctival redness and chemosis decreased over the observation time. Thus, according to the requirements specified by regulation (EC) No 1272/2008 and GHS-UN, the 1% aqueous solution of the registration substance has to be classified in Category 2A , reversible effects on the eye.
Respiratory irritation
There are currently no validated animal or in vitro tests that deal specifically with respiratory tract irritation. The Guidance on the Application of the CLP Criteria, Version 4.0, Nov. 2013 states that: "In general, a classification for corrosivity is considered to implicitly cover the potential to cause RTI [= respiratory tract irritation] and so the additional [STOT-SE] Category 3 is considered to be superfluous".
The classification of the substance as corrosive, Category 1C is considered to cover and communicate the potential for respiratory tract irritation adequately.
Based on reliable, adequate and relevant data, the registration substance has to be classified in Category 1C according to CLP, EU GHS (Regulation (EC) No 1272/2008) and GHS-UN and is assigned the hazard statement H314 “Causes severe skin burns and eye damage”.
The technical material as manufactured is a liquid with ca. 20% w/w active ingredient and ca. 80% w/w water. A water-free form of the technical material (dry technical material) is not manufactured or sold for commercial purposes.
The 20% aqueous solution of the registration substance is classified as irritating to the skin (Category 2) and causing irreversible effects on the eye (Category 1) and labelled with H315 (Causes skin irritation) and H318 (Causes serious eye damage) according to regulation (EC) No 1272/2008 and GHS-UN. A 1% aqueous solution of the registration substance is causing reversible effects on the eye (Category 2A) and has to be labelled with H319 (Causes serious eye irritation) according to regulation (EC) No 1272/2008 and GHS-UN.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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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