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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 939-424-4 | CAS number: 1469983-44-5
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 6 animals instead of 3
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
Test material
- Reference substance name:
- Diacid 1550
- IUPAC Name:
- Diacid 1550
- Reference substance name:
- C21 Dicarboxylic Fatty Acid
- IUPAC Name:
- C21 Dicarboxylic Fatty Acid
- Reference substance name:
- 5(or 6)-carboxy-4-hexylcyclohex-2-ene-1-octanoic acid
- EC Number:
- 258-897-1
- EC Name:
- 5(or 6)-carboxy-4-hexylcyclohex-2-ene-1-octanoic acid
- Cas Number:
- 53980-88-4
- Molecular formula:
- C21H36O4
- IUPAC Name:
- 5-(7-carboxyheptyl)-2-hexylcyclohex-3-ene-1-carboxylic acid
- Details on test material:
- - Name of test material (as cited in study report): Diacid 1550 Tall Oil Fatty Acid (C21 Dicarboxylic Fatty Acid)
- Physical state: Liquid
- Lot/batch No.: No data
- Storage condition of test material: Ambient temperature
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: S&S Associates
- Age at study initiation: young adult
- Weight at study initiation: 2.3-3.5 kg
- Housing: Housed individually in stainless steel pens with raised flooring suspended over drip pans lined with absorbent paper bedding.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.3-23.8
- Humidity (%): 40-60
- Air changes (per hr): conditioned room
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted (100%) - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1 hour after installation, and 24, 48 and 72 hours after, and thereafter daily for 21 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): flushing
- Time after start of exposure: 24 hours
SCORING SYSTEM: The numerical scorings recorded were made in compliance with OECD guideline 405, 1992, scoring ocular lesions (corneal, iridic and conjunctival irritation, and discharge).
TOOL USED TO ASSESS SCORE: No data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24 h
- Score:
- ca. 0.16
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: 3 animals exhibited fibrovascular connective tissue (an indication of corrosion)
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 48 h
- Score:
- ca. 0.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: 3 animals exhibited fibrovascular connective tissue (an indication of corrosion)
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 72 h
- Score:
- ca. 0.66
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: 3 animals exhibited fibrovascular connective tissue (an indication of corrosion)
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24 h
- Score:
- ca. 0.16
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 48 h
- Score:
- ca. 0.16
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 72 h
- Score:
- ca. 0.16
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24 h
- Score:
- ca. 2.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 48 h
- Score:
- ca. 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 72 h
- Score:
- ca. 1.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24 h
- Score:
- ca. 2.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 48 h
- Score:
- ca. 2.16
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 72 h
- Score:
- ca. 2.16
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritant / corrosive response data:
- Immediately after dosing, all 6 test animals displayed pawing and rubbing of the test eye. 24 hours after dosing, 1 test animal displayed corneal irritation with scattered or diffuse areas of opacity but details of iris still clearly visible. By 48 hours, 3 more animals developed this type of corneal opacity. By Day 7, 2 of these 3 animals exhibited fibrovascular connective tissue (an indication of corrosion) and a third test animal developed it on Day 10. The remaining 3 test animals showed complete recovery or significant improvement by Day 21.
During the 72-hour observation period, 3 test animals exhibited markedly deepened folds, congestion, swelling, moderate circumcorneal injection with iris still reacting to light. On Day 7, a fourth animal developed the same type of irritation and one animal recovered from the irritation.
One hour after dosing, all 6 test animals displayed conjunctivae irritation. This irritation ranged from some vessels definitely injected to diffuse, crimson red, individual vessels not easily discernible. 5 of the 6 test animals' irritation became more severe by 24 hours. Complete recovery or slight recovery was observed in 3 of the animals by Day 21.
One hour after dosing, all 6 test animals exhibited chemosis, ranging from swelling with lids about half closed to swelling with lids more than half closed. This swelling improved slightly by 24 hours, in 4 of the 6 test animals. Recovery was observed in 3 of the test animals by Day 10.
One hour after dosing, 2 of the 6 test animals displayed slight discharge (any amount different from normal). At 24 hours after dosing, another 3 test animals exhibited discharge ranging from any amount different than normal to discharge with moistening of the lids and hairs, and considerable area around the eye. At Day 7, hair loss around the test eye was observed in one test animal. Additionally, 2 test animals developed a bloody discharge by Day 10. Complete recovery was observed in 3 of the 6 test animals by Day 21. - Other effects:
- Not relevant
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- When tested as specified, the submitted test substance, Diacid 1550 Tall Oil Fatty Acid, induced eye irritation in all 6 test rabbits. The average mean scores calculated from the numerical values given to the eye irritation observed at the 24, 48, and 72 hour examinations of the 6 rabbits were 0.16, 0.5, and 0.66 for corneal irritation, and 0.16 for iris irritation, 2.66, 2.0, and 1.66 for conjunctivae (redness) irritation, and 2.66, 2.16, and 2.16 for chemosis. Fibrovascular connective tissue (an indication of corrosion) was observed in 2 of the test animals by Day 7 and a third by Day 10. Complete recovery or slight recovery was observed in the remaining 3 test animals by Day 21. Based on these results and according to the EU criteria outlined in Annex VI of 67/548/EEC and Annex I of 1272/2008/EC (CLP/EU-GHS), Diacid 1550 Tall Oil Fatty Acid has to be classified and labeled as corrosive to the eyes.
- Executive summary:
The primary eye irritation potential of Diacid 1550 Tall Oil Fatty Acid was investigated according to OECD test guideline no. 405, 1992. The test item was applied by instillation of 0.1 ml into one eye of each of 6 young adult New Zealand White rabbits for 24 hours. Scoring of irritation effects was performed approx. 1, 24, 48 and 72 hours after test item instillation, in compliance with OECD 405, scoring ocular lesions (corneal, iridic and conjunctival irritation, and discharge). Observation period was 21 days. When tested as specified, the submitted test substance, Diacid 1550 Tall Oil Fatty Acid, induced eye irritation in all 6 test rabbits. The average mean scores calculated from the numerical values given to the eye irritation observed at the 24, 48, and 72 hour examinations of the 6 rabbits were 0.16, 0.5, and 0.66 for corneal irritation, and 0.16 for iris irritation, 2.66, 2.0, and 1.66 for conjunctivae (redness) irritation, and 2.66, 2.16, and 2.16 for chemosis. Fibrovascular connective tissue (an indication of corrosion) was observed in 2 of the test animals by Day 7 and a third by Day 10. Complete recovery or slight recovery was observed in the remaining 3 test animals by Day 21. Based on these results and according to the EU criteria outlined in Annex VI of 67/548/EEC and Annex I of 1272/2008/EC (CLP/EU-GHS), Diacid 1550 Tall Oil Fatty Acid has to be classified and labeled as corrosive to the eyes.
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.