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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 238-914-9 | CAS number: 14852-17-6
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- data is from experimental reports
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- To assess the ocular irritation parameter of the test chemical in accordance with OECD 405
- GLP compliance:
- no
Test material
- Reference substance name:
- Ethylenediamine, salt with phosphoric acid
- EC Number:
- 238-914-9
- EC Name:
- Ethylenediamine, salt with phosphoric acid
- Cas Number:
- 14852-17-6
- Molecular formula:
- C2H8N2.xH3O4P
- IUPAC Name:
- ethane-1,2-diamine; phosphoric acid
- Test material form:
- solid: particulate/powder
- Details on test material:
- Name of the test chemical: ethylenediamine, salt with phosphoric acid
Molecular Formula: C2H11N2O4P
Molecular Weight: 158.094 g/mol
Physical State: Solid, White powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- -Source : In-bred
-Age : 10 to 12 weeks
-Body weight range : -Source : In-bred
-Age : 10 to 12 weeks
-Body weight range : 1.80kg ±200gg
-Identification : By cage tag and corresponding colour body marking.
-Acclimatization : The healthy rabbits selected for study was acclimatized to standard laboratory condition for one week in experimental room under Veterinary examination.
-Randomization : After acclimatization and Veterinary examination three females were randomly selected.
-Accommodation : Animals were housed individually in stainless steel cages provided with stainless steel mesh bottom and facilities for food and water bottle.
-Diet : Pelleted feed supplied by Pranav agro Industries Ltd., Delhi
-Water : Community tap water passed through ‘Aqua Guard on line water filter’, was kept in glass bottles, ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C):22-25 deg.C
- Humidity (%): 40-60%
- Air changes (per hr): 10-15 air changes per hour
- Light and Dark Cycle: illumination cycle set to 12 hours artificial fluorescent light and 12 hours dark.
Test system
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 gm moistened with distilled water
- Duration of treatment / exposure:
- the eyelids were gently pulled together for about one second to prevent loss of material
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after test substance application
- Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed
SCORING SYSTEM:Scale of weighted scores for grading the severity of ocular lesions developed by Draize et al
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: hand-slit lamp
Examination of reactions was facilitated by use of biomicroscope and hand slit lamp. After recording the observations at 24 hours, the eyes were further examined with the aid of fluorescein.
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.5
- Max. score:
- 110
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- In the initial test, the test chemical produced slight redness and mild discharge after 2 hours of application of test compound. This condition was recovered after 24 hours. Furthermore, no other clinical signs were recorded after application of test compound such as cage side activity, pain etc
In the confirmatory test, the test chemical produced slight redness of conjunctivae after two hour of application of test compound upto 24 hours. However, there was no other clinical sign recorded in both of the animals during the whole observation period for 21 days. - Other effects:
- The test compound when applied in conjunctival sac of rabbits did not show any observable clinical signs such as cage side activity and pain or stress etc. throughout the observation period of 21 days
Any other information on results incl. tables
TABLE- 1 GRADING OF OCULAR LESIONS
S.NO/ SEX |
|
OBSERVATION |
Score |
Total |
Total Score |
|||
1/F
|
1 hour |
24hours |
48 hours |
72 hours |
||||
Cornea |
A. Opacity-Degree of Density |
0 |
0 |
0 |
0 |
0 |
0×0×5=0 |
|
B. Area of Cornea Involved |
0 |
0 |
0 |
0 |
0 |
|||
Iris |
A. Values |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
A. Redness |
1 |
0 |
0 |
0 |
0 |
1+0+1×5=10 |
|
B. Chemosis |
0 |
0 |
0 |
0 |
0 |
|||
C. Discharge |
0 |
1 |
0 |
0 |
0 |
|||
2/F |
Cornea |
A. Opacity-Degree of Density |
0 |
0 |
0 |
0 |
0 |
0×0×5=0 |
B. Area of Cornea Involved |
0 |
0 |
0 |
0 |
0 |
|||
Iris |
A. Values |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
A. Redness |
1 |
0 |
0 |
0 |
0 |
1+0+1×5=10 |
|
B. Chemosis |
0 |
0 |
0 |
0 |
0 |
|||
C. Discharge |
0 |
1 |
0 |
0 |
0 |
|||
3/F |
Cornea |
A. Opacity-Degree of Density |
0 |
0 |
0 |
0 |
0 |
0×0×5=0 |
B. Area of Cornea Involved |
0 |
0 |
0 |
0 |
0 |
|||
Iris |
A. Values |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
A. Redness |
1 |
0 |
0 |
0 |
0 |
1+0+1×5=10 |
|
B. Chemosis |
0 |
0 |
0 |
0 |
0 |
|||
C. Discharge |
0 |
1 |
0 |
0 |
0 |
|||
Grand total |
30 |
|||||||
Mean |
10 |
|||||||
Eye Irritation Scoring index |
2.5 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- In the initial test, the test chemical produced slight redness and mild discharge after 2 hours of application of test compound. This condition was recovered after 24 hours. Furthermore, no other clinical signs were recorded after application of test compound such as cage side activity, pain etc
In the confirmatory test, the test chemical produced slight redness of conjunctivae after two hour of application of test compound upto 24 hours. However, there was no other clinical sign recorded in both of the animals during the whole observation period for 21 days.
Also the overall irritation score was calculated to be 2.5/110. According to the irritation parameter propised by Kay & Calandra, the test chemical can be consdiered to be practically not irritating to eyes,
It can be classified under the category "Not Classified". - Executive summary:
The acute eye irritation study of the test chemical was conducted in New Zealand White Rabbit as per the OECD- 405 Guideline. 3 female young adult New Zealand White rabbits were used for the study.
One healthy rabbits of body weight 1.96kg was selected for study after acclimatization. Both eyes of rabbits were examined for any abnormal discharge such as eye irritation, ocular defects or pre-existing corneal injury from eye 24 hours prior to application of test compound.
The test compound was applied in the conjunctival sac of rabbit after gently pulling the lower lid away from the eyeball at the dose rate of0.1gm.The lids were then gently held for about one second in order to prevent loss of the material. The other eye which remain untreated, served as a control. The acute irritation to eye conjunctiva, cornea and iris was evaluated at 1, 24, 48 and 72 hoursafter the treatment. The grades of ocular reaction (conjunctiva, cornea and iris) were recorded at each observation. To determine the reversibility of the effect the animal was observed normally for 21 days. Any other lesions in the eye viz pannus, staining were observed and scored accordingly. Examination of reactions was facilitated by use of biomicroscope and hand slit lamp. Individual animal weight before and during the study was observed.
The test chemical produced slight redness and mild discharge after 2 hours of application of test compound. This condition was recovered after 24 hours. Furthermore, no other clinical signs were recorded after application of test compound such as cage side activity, pain etc
A confirmatory test was performed using two additional animals according to the same procedure. The acute irritation to eye conjunctiva, cornea and iris was evaluated at 1, 24, 48 and 72 hours after the treatment. The grades of ocular reaction (conjunctiva, cornea and iris) were recorded at each observation. To determine the reversibility of the effect the animals were observed normally for 21 days. Any other lesions in the eye viz pannus, staining were observed and scored accordingly. Examination of reactions was facilitated by use of biomicroscope and hand slit lamp. Individual animal weight before and during the study was observed.
In the confirmatory test, the test chemical produced slight redness of conjunctivae after two hour of application of test compound upto 24 hours. However, there was no other clinical sign recorded in both of the animals during the whole observation period for 21 days.
Also the overall irritation score was calculated to be 2.5/110. According to the irritation parameter propised by Kay & Calandra, the test chemical can be consdiered to be practically not irritating to eyes,
It can be classified under the category "Not Classified".
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.