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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 266-722-5 | CAS number: 67583-77-1
- 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: not irritating (OECD 431, GLP, K, Rel.1; OECD 439, GLP, K, Rel.1)
Eye irritation: not irritating (OECD 405, GLP, K, Rel.1)
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
Some data are available for skin irritation but the results are contradictory:
- skin irritation/in vivo (Pitterman, 1993) : corrosive
- skin irritation/in vivo study (Potokar, 1981): not an irritant at 5%
- acute dermal toxicity study (Cerven, 1993): no irritation observed
- skin sensitisation/old study (Potokar, 1979): low irritation observed
- Skin sensitisation/LLNA (Sanders, 2016): no irritation observed
- new study on eye irritation/vivo (Sanders, 2016): very low irritation observed
A study (Pitterman, 1993) was well conducted in compliance with OECD Guideline 404 however the results are inconsistent with those from the other studies. Moreover, the purity of Henkel's substance is not mentioned and therefore the corrosive effects observed in this study might be due to the different quality (impurities).
- According to the inconsistencies between all the results, and according to the result of the new 405 eye irritation study, an in vitro test (Warren, 2016) was performed according to the OECD Guideline No. 431 and in compliance with GLP to confirm the classification. In this study, EpiDerm™ Human Skin Models are used to assess skin corrosion. Duplicate tissues were treated with the test item for exposure periods of 3 and 60 minutes. Negative and positive control groups were treated for each exposure period. The quality criteria required for acceptance of results in the test were satisfied. The relative mean viability was 106.5% after a 3 -minute exposure period and 101.5% after a 60 -minute exposure period. The test item was therefore considered to be non-corrosive to the skin.
- As required in Intelligent Testing Strategy for skin irritation, an EPISKIN™ irritation study (Warren, 2016) was performed according to the OECD Guideline No. 439 and in compliance with GLP to determine if the substance is irritant or not after a treatment period of 15 minutes followed by a post-exposure incubation period of 42 hours. The quality criteria required for acceptance of results in the test were satisfied. The relative mean viability of the test item treated tissues was 95.8%, after the 15 -minute exposure period and 42 hours post-exposure incubation period. With a tissue viability >50%, the test substance was considered to be non-irritant to skin.
CONCLUSION: Regarding all this results, the substance is considered to be non-irritant for the skin.
Eye irritation:
Two old studies were performed to assess eye irritation, an in vitro (Steiling, 1995) and an in vivo (Potokar, 1981) study. The result of the HET-CAM in vitro study was slightly irritating according to the study report but severely irritating according to the ICCVAM criteria. Moreover, the in vivo study was performed with a test material concentration at 5% so even if no irritation were observed between 24 and 72h, this study can't be used for classification based on the low substance concentration. Based on inconsistency of available data and results, it has been decided that BCOP was not relevant to assess the eye irritation of the substance since this method is only used to determine if a substance is not classified for eye irritation or classified in Cat.1. Therefore, a new in vivo study according to the OECD Guideline No. 405 and in compliance with GLP was performed. In this eye irritation study, 0.1 mL of undiluted test material was instilled into one eye of two male New Zealand White rabbits. The other eye remained untreated and served as control. The upper and lower eyelids were held together for about one second immediately after instillation. The eyes were examined and the changes were observed at 1, 24, 48 and 72 h after treatment and graded according to the Draize method.
The calculated mean score for each animal within 3 scoring times (24, 48 and 72 h) were 0.0/0.0 for the corneal opacity and iridial inflammation, 0.7/0.7 for conjunctival redness and 0.3/0.3 for chemosis. The effects observed were all reversible within 72 hours. The substance is therefore not classified for eye irritation.
CONCLUSION: Regarding all this results, the substance is considered to be non-irritant for the eyes.
Justification for classification or non-classification
Harmonized classification:
The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008 and to the GHS.
Self classification:
Based on the available data, no additional self-classification is proposed regarding both skin and eye irritation according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and according to the GHS.
No data was available regarding respiratory irritation. However, the substance not being classified for skin and eye irritation, no classification is expected for respiratory irritation
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.