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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 701-204-9 | 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:
- 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to an internationally approved guideline and followed Good Laboratory Practice standards.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Deviations to temperature and humidity were slight and did not compromise any aspect of this study.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction products of fatty acids, C14-C18 (branched and linear) and C18 (unsaturated) with tetraethylenepentamine (linear, branched, cyclic)
- EC Number:
- 701-204-9
- Cas Number:
- 68784-17-8
- IUPAC Name:
- Reaction products of fatty acids, C14-C18 (branched and linear) and C18 (unsaturated) with tetraethylenepentamine (linear, branched, cyclic)
- Test material form:
- liquid: viscous
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Source: Myrtle's Rabbitry Incorporated, Thompson Station, TN
- Housing: wire mesh suspension cage, 1 rabbit/ cage
- Diet (e.g. ad libitum): TEKLAB RABBIT DIET (or otehr comparable diet)
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: at least 7 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21
- Humidity (%):30-60%
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
IN-LIFE DATES: 17 September, 1993 – 19 October 1993
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1mL - Duration of treatment / exposure:
- Test material was instilled into one eye of the test animal while the other eye remained untreated to serve as a control. Nine animal of either sex (Group 1 - six animals; Group 2 - three animals). The eyes of the six rabbit in Group 1 were not rinsed following instillation of the test material. The treated eyes of the three rabbits in Group 2 were rinsed after 30 seconds of test material contact for approximately one minute with approximately 200 mL of lukewarm tap water.
- Observation period (in vivo):
- The treated eyes of all animals were examined for ocular irritation at 1, 24, 48, 72, and 96 hours and on Days 7 and 14 after treatment. With the exception of the 1 hour scoring, all eyes were scored again for corneal opacity, intensity, and area usig sodium fluorescein. Irritation was graded and scored using the Driaze technique. All eye abnormalities were recorded. Apparent test material residue were adhered to the cornea of two nonrinsed animals in Group 1, animals 1-688 and 2-689. Following the 24 hour reading, an attempt was made to remove the residue using a cotton swab moisterened with saline and/or gentle rinsing of the eyes with saline. A definitive determination could not be made as to whether or not all residue had been removed. This situation was deemed to represent an unrealistic evaluation of the potential to cause eye irritation in humans. Therefore, these animals were considered compromised and subsequently euthanized. The data collected from these animals were not considered for classification and are not presented in this study. Two additonal animals were initiated in the nonrinsed group to serve as replacements for the compromised animals. Each animal was observed daily for any physiological or behavioral abnormalities.
All animals at termination of the experimental phase were euthanized according to laboratory SOPs and discarded.
No statisical analysis was conducted for the evaluation of data. - Number of animals or in vitro replicates:
- Nine rabbits
- Details on study design:
- SCORING SYSTEM: Draize scoring
TOOL USED TO ASSESS SCORE: Sodium fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: nonrinsed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: nonrinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Reversibility:
- fully reversible within: 96 h
- Remarks on result:
- other: nonrinsed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: nonrinsed
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: rinsed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Reversibility:
- fully reversible within: 96 h
- Remarks on result:
- other: rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.9
- Reversibility:
- fully reversible within: 96 h
- Remarks on result:
- other: rinsed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: rinsed
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Under the conditions of this study, EC701-204-9 is classified as a Category 2 eye irritant in accordance with Regulation (EC) No 1272/2008.
- Executive summary:
The primary ocular irritancy of undiluted test material (C1234 -04 -01) was evaluated in compliance with conditions specified in the regulation for the enforcement of the Federal Insecticide, Fungicide, and Rodenticide Act (40 CFR), the Toxic Substances Control Act (40 CFR), and the OECD Guidelines.
The test material produced corneal opacity which had cleared by the Day 14 reading, and conjunctival irritation which had cleared by the Day 14 reading, when applied without rinsing to the eyes of six New Zealand White rabbits. Maximum total irritation scores for individual nonrinsed animals ranged from 12 to 19. the mean total irritation score at the 24 hour reading was 11.7 /110. Positive responses were exhibited by 6/6. No evidence of corrosion was noted. No physiological or behavioral abnormalities were noted.
The test material produced corneal opacity which had cleared by the 72 hour reading, iritis which had cleared by the 96 hour reading, and conjunctival irritation which had cleared by the Day 14 reading, when applied with rinsing to the eyes of three New Zealand White rabbits. Maximum total irritation scores for individual rinsed animals ranged from 14 to 20. The mean total irritation score at the 24 hour reading was 12.7/110. Positive responses were exhibited by 3/3. No evidence of corrosion was noted. No physicological or behavioral abnormalities were noted.
Rinsing appeared to have no significant effect on the severity or persistence of the ocular irritation produced in response to the test material.
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.