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EC number: 252-091-3 | CAS number: 34562-31-7
- 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
Moderately irritating to skin, mildly irritating to eyes, in vivo
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4470 (Acute Dermal Irritation)
- Principles of method if other than guideline:
- This study was conducted at Product Safety Labs in compliance with Good Laboratory Practices as defined in 40 CFR 792; U.S. EPA Good Laboratory Practice Standards; Toxic Substances Control Act (TSCA) and in accordance with Health Effects Testing Guidelines, Subpart E: Primary Dermal Irritation, 40 CFR 798.4470
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Number of Animals: 6 (3 males and 3 females), adult rabbits
Initial bodyweights: 1.9-2.1 kg
Received from Davidson's Mill Farm, South Brunswick, NJ
The animals were single housed in suspended stainless steel caging with mesh floors which conform to size recommendations
Litter paper was placed beneath the cage and was changed at least three times per week
Room temperature was kept between 67-75 deg F
12 hour light/dark cycle
Rabbits were given pelleted purina rabbit chow and filtered tap water ad libitum - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml of the test substance
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, and 72 hours, and 7, 10, and 14 days after patch removal
- Number of animals:
- 6
- Details on study design:
- One the day before application, a group of animals was prepared by clipping the dorsal area and the trunk. After shaving and just prior to application, the animals were weighed, examined for health and the skin checked for any abnormalities. Five tenths of a millileter of the test substance was applied to one 6 cm x 6 cm intact dose site on each animal and covered with a 2 1/4 x 4'' adhesive-backed gauze patch. The patch and entire trunk of each animal were then wrapped with semiocclusive 3' micropore tape to avoid dislocation of the patch. Elizabethan collars were placed on each rabbit and they were returned to their designated cage.
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 2.5
- Max. score:
- 8
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- probability of moderate irritation
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Based on the scoring system used, the test material is classified as moderately irritating to the skin when applied as received.
Reference
Based on the scoring system used, the test material is classified as moderately irritating to the skin when applied as received.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- Version / remarks:
- according to 40 CFR Part 792
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- 4 males and 2 females
Adult rabbits received from Davidson's Mill Farm, South Brunswick, NJ
All animals were housed singly in suspended stainless steel caging with mesh floors which conform to size recommendations.
Litter paper was placed beneath the cage and was changed at least three time per week.
Room temperature was kept at 68-70oF
12 hour light/dark cycles
Acclimation period of 14 days
Animals were given pelleted Purina Rabbit Chow and Filtered Water was supplied ad libitum - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- One-tenth of a millileter
- Duration of treatment / exposure:
- One eye of each rabbit received the test substance and was applied to the eye for 1 second before releasing
- Observation period (in vivo):
- Animals were observed for 7 days for signs of eye irritation
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- 6 rabbits recieved one-tenth of a millilter of the test substance instilled into the conjunctival sac of the right eye by pulling the lower lid away from the eyeball. The upper and lower lids were then gently held together for about 1 second before releasing, to prevent loss of the test substance. The other eye of each rabbit remained untreated to serve as a control. Elizabethan collars were placed on each rabbit and they were returned to their cages. Ocular irritation was evaluated using a high-intensity white light at 1,24, 48, and 72 hours and 4 and 7 days post instillation. Twenty four hours after instillation, collars were removed. The animals were observed for signs of toxicity, behavioral changes, and mortality at least once daily during the test period.
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- 24 h
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- probability of mild irritation
- Irritant / corrosive response data:
- Mildly irritating to eyes
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Conclusions:
- The test material was tested in a study for eye irritation in vivo. Mild conjunctivitis was observed in all animals through day 4, and mild iritis was observed in 2 of 6 animals through day 4. The substance is classified as mildly irritating to the eye.
Reference
Results: Eye Irritation,
Wnorowski, 1994
Time: | Incidence of Irritation | ||
Hours | Corneal Opacity | Iritis | Conjunctival Irritation |
1 | 0/6 |
2/6 | 5/6 |
24 | 0/6 |
1/6 | 6/6 |
48 | 0/6 |
1/6 | 6/6 |
72 | 0/6 |
1/6 | 6/6 |
Days | |||
4 | 0/6 |
1/6 | 6/6 |
7 | 0/6 |
0/6 | 0/6 |
Mean Scores per Timepoint
MMTS (Draize)
Time: | MMTS | ||||||
Hours | 5544 | 5545 | 5546 | 5547 | 5548 | 5549 | Mean MMTS |
1 | 17 | 12 | 15 | 10 | 8 | 10 | 12 |
24 | 12 | 8 | 17 | 12 | 14 | 14 | 12.8 |
48 | 6 | 4 | 17 | 8 | 10 | 8 | 8.8 |
72 | 8 | 4 | 17 | 8 | 10 | 6 | 8.8 |
Days | |||||||
4 | 8 | 4 | 17 | 8 | 10 | 6 | 8.8 |
7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
According toKay and Calandra,J. Soc. Cos. Chem. 13: 281-289, 1962)
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The substance was tested in an in vitro corrosion study (Corrositex) and an in vivo DOT corrosion study, and found to be non-corrosive. The substance was also tested in a rabbit skin irritation study according to a U.S. DOT protocol (occlusive exposure), and found to be moderately irritating. No systemic toxicity was noted at a dose of > 2000 mg/kg bw. An eye irritation study, similar to an OECD 405, was undertaken and the substance was found to be mildly irritating, with iritis and conjuctivitis present through day 4 (of 7).
Justification for classification or non-classification
The substance is irritating to skin and eye, in in vivo testing using older but established U.S. protocols. The substance is classified as irritating to skin, Category 2, and to eye, Category 2B.
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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