Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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: 244-742-5 | CAS number: 22036-77-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24.8.1982-27.8.1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was carried out according to current OECD guideline and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- EDTMP-6Na
- IUPAC Name:
- EDTMP-6Na
- Reference substance name:
- Hexasodium dihydrogen [ethane-1,2-diylbis[nitrilobis(methylene)]]tetrakisphosphonate
- EC Number:
- 239-204-1
- EC Name:
- Hexasodium dihydrogen [ethane-1,2-diylbis[nitrilobis(methylene)]]tetrakisphosphonate
- Cas Number:
- 15142-96-8
- Molecular formula:
- C6H14N2O12P4.6Na
- IUPAC Name:
- hexasodium dihydrogen {ethane-1,2-diylbis[nitrilobis(methylene)]}tetrakis(phosphonate)
- Details on test material:
- - Name of test material (as cited in study report): Briquest 422-25S
- Storage condition of test material: at ambient temperature
- pH: 8
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.11-2.30 kg
- Housing: individually housed in suspended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 +/- 2.5
- Humidity (%): 68-70
- Air changes (per hr): ca. 15
- 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 - Duration of treatment / exposure:
- single instillation
- Observation period (in vivo):
- Assessment of irritation was made 1, 24, 48 and 72 hours following treatment.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- The test material produced no evidence of positive ocular irritation in any rabbit.
- Other effects:
- A dulling of the normal lustre of the cornea was observed in two rabbits at the one hour reading only. Mild conjunctival inflammation and swelling were seen in all three rabbits at this reading. The reactions had ameliorated completely in two rabbits by the 24 hours reading. MIld conjunctival inflammation persisted in the remaining rabbit until the 24 hours observation.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The test material was found not irritating to rabbit eye in a study conducted according to current guideline and in compliance with GLP.
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.
