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EC number: 233-701-7 | CAS number: 10319-14-9
- 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
Skin irritation: non-irritant
Eye irritation: non-irritant
Key value for chemical safety assessment
Additional information
The substance was tested for skin irritation potential using the patch test technique described in the consumer product safety commission of the U.S.A. in the code of federal regulations, title 16, section 1500.41.
In the test report, skin reaction scores at 0 h and 72 h after patch removal are given. For the purposes of calculating erythema and oedema scores at non-given time points (after patch removal), the following is done: - scores at 24 h are taken also as scores at 48 h. The mean skin reaction scores are calculated from values at 24, 48 and 72 h after patch removal.
Intact and abraded skin showed no skin reactions at all for oedema; 2/6 rabbits show very slight edema at 24h, but this skin reactions were reversible within 72h.
For all animals, the calculation of mean skin reaction scores (24, 48 and 72 h) after patch removal gave the following values for intact skin: erythema score abraded and intact skin <1 and oedema score = 0 for abraded and intact skin.
Therefore, the test substance is a non-skin irritant.
In order to assess the eye irritation potential of the substance two test as weight of evidence were used.
The first test was available on disperse yellow 64.
The substance was tested for eye irritation potential according to the technique described in the consumer product safety commission of the U.S.A. in the code of federal regulations, title 16, section 1500.42.
78 mg of test substance was instilled into one eye of each animal, the other eye remaining untreated, served as control.
Eye reactions were scored at 1 d, 2 d, 3 d, and 7 d after exposure.
In two animals at day 7 slight effect on redness was still present.
The mean irritation indexes (at 1, 2 and 3 d) were the following:
Corneal score: (5/6)=0; 1/6 =1
iris score (6/6) = 0.
conjunctivae score (6/6) <2
chemosis (6/6) < 2
The test substance can be considered a non-eye irritant.
Anyway as the test ends at day 7 it is not possible to see the irreversible effect until day 21 and in two animals at day 7 there was still a slight effect on redness.
Therefore another test on similar substance 1 was used as Weight of evidence in order to support the non-classification for eye in the substance.
This test was performed according to OECD 405 and GLP. Each of 3 female rabbits received instillations of about 30 mg test substance into the conjunctival sac of the right eye; the respective left eye remained untreated and served as control. The eyes of the animals were observed 1, 24, 48 and 72 hours post application. Additionally, 24 hours post application the eyes were treated with fluorescein and examined . The scoring was done according to Draize. In none of the animals eyes were affected by treatment. The substance was evaluated to be non-irritating to the eyes of rabbits.
Therefore, also similar substance 1 is considered as a non-eye irritant.
Justification for classification or non-classification
For skin irritation and eye irritation, the CLP Regulation (EC 1272/2008) was used for overall judgment.
In the CLP Regulation (EC 1272/2008), skin irritation is defined as "the production of reversible damage to the skin following the application of a test substance for up to 4 hours." The same regulation, defines a Category 2 skin irritant as "Mean value of ≥ 2,3 - ≤ 4,0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal."
Therefore, the test substance is a non-skin irritant.
Moreover the CLP Regulation (EC 1272/2008), defines eye irritation as follows: "Eye irritation means the production of changes in the eye following the application of test substance to the anterior surface of the eye, which are fully reversible within 21 days of application." The same regulation defines a Category 2 eye irritant as, "if, when applied to the eye of an animal, a substance produces: — at least in 2 of 3 tested animals, a positive response of: — corneal opacity ≥ 1 and/or — iritis ≥ 1, and/or — conjunctival redness ≥ 2 and/or — conjunctival oedema (chemosis) ≥ 2 — calculated as the mean scores following gradings at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days."
Therefore, based on these results, the test material is considered as a non-eye irritant.
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