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EC number: 701-269-3 | 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, other
- Remarks:
- In vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From 24 May 2012 to 01 June 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read across study hence maximum reliability rating of 2 assigned according to ECHA guidance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
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:
- Octadecanoic acid, 12-hydroxy-, reaction products with ethylenediamine
- IUPAC Name:
- Octadecanoic acid, 12-hydroxy-, reaction products with ethylenediamine
- Reference substance name:
- 100545-48-0
- Cas Number:
- 100545-48-0
- IUPAC Name:
- 100545-48-0
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Octadecanoic acid, 12-hydroxy-, reaction products with ethylenediamine
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Two New Zealand White (Hsdlf:NZW) strain rabbits were supplied by Harlan Laboratories UK Ltd., Leicestershire, UK. At the start of the study the animals weighed 2.62 or 3.01 kg and were 12 to 20 weeks old. After an acclimatisation period of at least 5 d 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.
The animals were individually housed in suspended 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.
The temperature and relative humidity were set to achieve limits of 17 to 23°C and 30 to 70% respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was at least 15 changes/h and the lighting was controlled by a time switch to give 12 h continuous light (06:00 to 18:00) and 12 h darkness.
The 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:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of the test substance (which was found to weigh approximately 66 mg)
- Concentration: Undiluted - Duration of treatment / exposure:
- Duration of treatment same as observation period.
- Observation period (in vivo):
- The eyes were examined for any ocular reaction approximately 1, 24, 48, and 72 h after the treatment.
- Number of animals or in vitro replicates:
- Two
- Details on study design:
- PROCEDURE:
Only animals free of ocular damage were used.
Initially, a single rabbit was treated. A volume of 0.1 mL of the test substance, which was found to weigh approximately 66 mg (as measured by gently compacting the required volume into an adapted syringe) was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test substance, and then released. The left eye remained untreated and was used for control purposes. Immediately after administration of the test substance, an assessment of the initial pain reaction was made according to the six point scale.
After consideration of the ocular responses produced in the first treated animal, a second animal was treated.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
SCORING SYSTEM: Draize scale for scoring ocular Irritation (Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.48 to 49).
TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 6
- Max. score:
- 110
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: Based on Draize scoring method
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 2
- Max. score:
- 110
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: Based on Draize scoring method
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 1
- Max. score:
- 110
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: Based on Draize scoring method
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: Based on Draize scoring method
- Irritant / corrosive response data:
- - No corneal or iridial effects were noted during the study.
- Minimal conjunctival irritation was noted in both the animals 1 and 24 h after treatment and in one animal at the 48-h observation. However, these effects were reversible within 48 h in one animal and within 72 h in the other animal.
See below tables for further details. - Other effects:
- Only one of the animal showed an expected gain in bodyweight during the study.
Any other information on results incl. tables
Table 1: Individual Scores and Individual Total Scores for Ocular Irritation
Rabbit Number and Sex | 72058 Male | 72080 Male | ||||||
Initial pain reaction = 1 | Initial pain reaction = 1 | |||||||
Time after treatment | 1 h | 24 h | 48 h | 72 h | 1 h | 24 h | 48 h | 72 h |
CORNEA | ||||||||
E = Degree of opacity | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
F = Area of cornea involved | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Score (E x F) x 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
IRIS | ||||||||
D | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Score (D x 5) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
CONJUNCTIVAE | ||||||||
A = Redness | 1 | 1 | 0 | 0 | 1 | 1 | 1 | 0 |
B = Chemosis | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
C = Discharge | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
Score (A + B + C) x 2 | 6 | 2 | 0 | 0 | 6 | 2 | 2 | 0 |
Total Score | 6 | 2 | 0 | 0 | 6 | 2 | 2 | 0 |
Table 2: Individual Total Scores and Group Mean Scores for Ocular Irritation
Rabbit Number and Sex | Individual total scores at: | |||
1 h | 24 h | 48 h | 72 h | |
72058 Male | 6 | 2 | 0 | 0 |
72080 Male |
6 | 2 | 2 | 0 |
Group Total | 12 | 4 | 2 | 0 |
Group Mean Score | 6.0 | 2.0 | 1.0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study, the test substance produced minimal conjunctival irritation which was reversible within 72 h.
- Executive summary:
An in vivo study was conducted to evaluate the acute eye irritation potential of the test substance in New Zealand White rabbits according to the EU Method B.5 and OECD Guideline 405 in compliance with GLP.
A volume of 0.1 mL of test substance (i. e, 66 mg) was placed into the conjunctival sac of the right eye of two New Zealand White rabbits without irrigation. The left eye remained untreated and was used for control purposes. Assessment of ocular damage/irritation was made approximately 1, 24, 48 and 72 h following treatment according to the Draize scoring method. No corneal or iridial effects were noted during the study. Minimal conjunctival irritation was seen in both animals 1 and 24 h after treatment and in one animal at the 48 h observation. These effects were reversible within 48 h in one animal and within 72 h in the other.
In conclusion, under the conditions of the study, the test substance produced minimal conjunctival irritation in rabbits which was reversible within 72 h
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