Registration Dossier
Registration Dossier
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: 943-537-4 | CAS number: -
- 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:
- 24 December 2014 to 06 May 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction product of C16-22, even, C18-rich, unsaturated and saturated triglycerides with, N-(2-hydroxypropylamine)
- Molecular formula:
- Too Complex
- IUPAC Name:
- Reaction product of C16-22, even, C18-rich, unsaturated and saturated triglycerides with, N-(2-hydroxypropylamine)
- Details on test material:
- - Physical state: Dark yellow viscous liquid
- Analytical purity: 100 %
- Expiration date of the lot/batch: 12 June 2016
- Storage condition of test material: Room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- ANIMALS AND ANIMAL HUSBANDRY
- Two New Zealand White rabbits (Hsdlf:NZW) were supplied by Harlan Laboratories UK Ltd, Leicestershire, UK
- At the start of the study the animals weighed 2.56 kg or 2.74 kg and were 12 to 20 weeks old.
- After an acclimatisation period of at least 5 days each animal was given a number unique within the study, which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label.
- Animals were individually housed in suspended metal cages.
- Free access to mains drinking water and food (2930C Teklad Global Rabbit diet supplied by Harlan Laboratories UK Ltd, Oxon UK) was allowed throughout the study.
- The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
- Temperature and relative humidity were set to achieve limits of 17 °C to 23 °C and 30 % to 70 % respectively.
- The rate of air exchange was at least 15 changes per hour.
- Lighting was controlled by a time switch to give 12 hours continuous light (06:00 to 18:00) and 12 hours darkness.
- Animals were provided with environmental enrichment items, which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- Two
- Details on study design:
- TEST ITEM FORMULATION AND EXPERIMENTAL PREPARATION
- The test item was used as supplied.
- Absorption of the test material was not determined.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: 74921 (male)
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: 74921 (male)
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: 74921 (male)
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: 74921 (male)
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #2
- Remarks:
- mean score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: 74944 (male)
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: 74944 (male)
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Remarks:
- mean score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: 74944 (male)
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: 74944 (male)
- Irritant / corrosive response data:
- - Individual and group mean scores for ocular irritation are given in Table 1 and Table 2 (attached).
Any other information on results incl. tables
MEASUREMENT OF pH
- Aqueous preparation of the test item (10 % w/w): pH 8.62 immediately; pH 8.31 after 10 minutes.
OCULAR REACTIONS
- No corneal or iridial effects were noted during the study.
- Moderate conjunctival irritation was noted in both treated eyes one hour after treatment with minimal conjunctival irritation noted at the 24 and 48 hour observations.
- Both treated eyes appeared normal at the 72 hour observation.
BODY WEIGHT
- Individual body weights and body weight change are given in Table 3 (attached).
- One animal showed body weight loss and the other animal showed expected gain in body weight during the study.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item produced a maximum group mean score of 11.0 and was considered to be a mild irritant to the rabbit eye according to a modified Kay and Calandra system (Class 4 on a 1 to 8 scale). However, the test material is not classified under the terms of Regulation (EC) No 1272/2008.
- Executive summary:
GUIDELINE
The study was performed in accordance with OECD Guideline for the Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion" (adopted 02 October 2013) and Method B.5 Acute Toxicity (Eye Irritation) of Commission Regulation (EC) No. 440/2008.
RESULTS
A single application of the test item to the non-irrigated eye of two rabbits produced moderate conjunctival irritation. Both treated eyes appeared normal at the 72 hour observation.
CONCLUSION
The test item produced a maximum group mean score of 11.0 and was considered to be a mild irritant to the rabbit eye according to a modified Kay and Calandra system (Class 4 on a 1 to 8 scale). However, the test material is not classified under the terms of Regulation (EC) No 1272/2008.
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.
