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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 216-913-4 | CAS number: 1696-20-4
- 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
The test item is neither irritating to the skin nor to the eye. Respiratory irritation is not expected.
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:
- 1967-03-22 to 1967-04-14
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study predating guidelines and GLP, but scientifically fully acceptable.
- Qualifier:
- no guideline followed
- Deviations:
- not applicable
- Principles of method if other than guideline:
- other: BASF test (close to Draize test), occlusive, 3 rabbits, intact skin, 20 h exposure (among others)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.83 kg (male); 3.10 kg (female); 2.72 kg (male)
ENVIRONMENTAL CONDITIONS
- no data
IN-LIFE DATES: From: 1967-03-29 To: 1967-04-14 - Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- undiluted (2 mL / animal (corresponds to 2.23 g)
- Duration of treatment / exposure:
- 1, 5 or 20 minutes
20 hours (data selected as worst case for 4 h test) - Observation period:
- Animal 1 (male, 7.6.645): 8 days, (day 3 and 4 lacking)
Animal 2 (female, 6.6.571): 5 days, (day 3 and 4 lacking)
Animal 3 (male, 5.6.427): 3 days - Number of animals:
- 3 rabbits
- Details on study design:
- TEST SITE
- Area of exposure: at six sites per rabbit along the dorsum (plus left ear, not considered)
- % coverage: approximately 6 cm2 each
REMOVAL OF TEST SUBSTANCE
- Washing: yes, mild detergent (50% Lutrol)
SCORING SYSTEM: Draize score (converted from recorded grading with detailed instructions provided by data owner) - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24 h, 48 h, and 5, 6, 7, 8 days (mean)
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Exposure duration 20 h (instead of 4 h, OECD 404)
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24 h, 48 h and 5 days (mean)
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Exposure duration 20 h (instead of 4 h, OECD 404)
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24 h, 48 h, 72 h (mean)
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: Exposure duration 20 h (instead of 4 h, OECD 404)
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24 h, 48 h, and 5, 6, 7, 8 days (mean)
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Exposure duration 20 h (instead of 4 h, OECD 404)
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24 h, 48 h, and 5, 6, 7, 8 days (mean)
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Exposure duration 20 h (instead of 4 h, OECD 404)
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24 h, 48, 72 h (mean)
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Exposure duration 20 h (instead of 4 h, OECD 404)
- Irritant / corrosive response data:
- not irritating (minimal signs of skin irritation (erythema grade 1) were noted after the 20 h exposure period in one animal at the 24h and 48h reading).
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not 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:
- 1967-03-22 to 1967-04-06
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study predating guidelines and GLP, but obtained by standardised procedures comparable to those presently in use and thus valid for characterising the toxicity of the substance tested.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not applicable
- Principles of method if other than guideline:
- other: BASF test, comparable to OECD 405, but eyes were not washed out after 24 h, standard readouts on workdays, and fluorescin was applied
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3 kg (male); 3.05 kg (female)
ENVIRONMENTAL CONDITIONS
- no data
IN-LIFE DATES: From: 1967-03-29 To: 1967-04-06 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: control eye: left eye of same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.05 mL of undiluted test item (corresponds to about 56 mg test item)
CONTROL MATERIAL
- Amount applied: 0.05 mL of "NaCl" (probably physiol. saline solution) - Duration of treatment / exposure:
- not applicable - eye not rinsed after 24 hours
- Observation period (in vivo):
- 8 days (readings at 1h, 24h, 48h and 8d after application)
- Number of animals or in vitro replicates:
- one male, one female
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM: Draize score (converted from recorded grading with detailed instructions provided by data owner)
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- other: 1 h, 24 h, 48 h and 8d (mean)
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: No 72 h readout in raw data, but as no irritation occurred, data point not necessary for evaluation
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a primary dermal irritation study (BASF 1967), Vienna White rabbits (two males and one female) were dermally exposed to 2 mL of undiluted test item for either 1, 5 or 15 minutes or 20 hours to six sites on the dorsum each (occlusive treatment, approximately 6 cm2 of body surface area each). Animals then were observed for 3 to 8 days. Irritation was scored at first by a grading system of the data owner, converted later into the scoring of Draize. Minimal signs of skin irritation (erythema grade 1) were noted after the 20 h exposure period in one animal at the 24h and 48h reading. In this study, the test item is not a dermal irritant. No labelling is required.
In a primary eye irritation study (BASF 1967), 0.05 mL (56 mg) of 4-acetylmorpholine was instilled into the conjunctival sac of the right eye of Vienna White rabbits (one male / one female). Eyes were not washed. Animals were then observed for 8 days. A 72 h readout could not be identified from the raw data, but as no irritation occurred throughout the entire observation period, the 72 h data point was not necessary for an evaluation. Irritation was scored at first by a grading system of the data owner, converted later into the scoring of Draize. 4-acetylmorpholine did not induce eye irritating effects at any of the time points examinated.
Respiratory irritation is not expected since the substance is not irritating to skin and eye and did not cause any clinical signs in the acute inhalation toxicity study when rats were exposed to a vapor saturated atmosphere (BASF, 1967).
Justification for selection of skin irritation / corrosion endpoint:
The key study was selected.
Justification for selection of eye irritation endpoint:
The key study was selected.
Justification for classification or non-classification
Based on the available data, the test item is not subject to C&L according to Directive 67/548/EEC or Regulation 1272/2008/EC.
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.