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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 701-216-4 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24.08.1982 to 27.08.1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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
Test material
- Reference substance name:
- octadecasodium ({[2-({2-[bis(hydrogen phosphonatomethyl)amino]ethyl}(hydrogen phosphonatomethyl)amino)ethyl](hydrogen phosphonatomethyl)amino}methyl)phosphonate {[(hydrogen phosphonatomethyl)({2-[(hydrogen phosphonatomethyl)({2-[(hydrogen phosphonatomethyl)(phosphonatomethyl)amino]ethyl})amino]ethyl})amino]methyl}phosphonate {[(hydrogen phosphonatomethyl)({2-[(hydrogen phosphonatomethyl)({2-[(hydrogen phosphonatomethyl)(phosphonomethyl)amino]ethyl})amino]ethyl})amino]methyl}phosphonate
- EC Number:
- 701-216-4
- Molecular formula:
- DTPMP-5Na C9H23N3Na5O15P5 DTPMP-6Na C9H22N3Na6O15P5 DTPMP-7Na C9H21N3Na7O15P5
- IUPAC Name:
- octadecasodium ({[2-({2-[bis(hydrogen phosphonatomethyl)amino]ethyl}(hydrogen phosphonatomethyl)amino)ethyl](hydrogen phosphonatomethyl)amino}methyl)phosphonate {[(hydrogen phosphonatomethyl)({2-[(hydrogen phosphonatomethyl)({2-[(hydrogen phosphonatomethyl)(phosphonatomethyl)amino]ethyl})amino]ethyl})amino]methyl}phosphonate {[(hydrogen phosphonatomethyl)({2-[(hydrogen phosphonatomethyl)({2-[(hydrogen phosphonatomethyl)(phosphonomethyl)amino]ethyl})amino]ethyl})amino]methyl}phosphonate
- Test material form:
- solid - liquid: aqueous solution
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Age at study initiation: Approximately 12-16 weeks old
Weight at study initiation: 2.15-2.34 kg,
Source: Hylyne Rabbits Ltd., Marston, Northwich, Cheshire, UK.
Diet: Rabbit diet J. Waring (feeds) Ltd, ad libitum
Water: Tap Water, ad libitum
Housing: Individually housed in suspended metal cages
Acclimatisation period: Minimum of 5 days
Environment
Temperature: 19.5 ±2.5°C
Air exchanges: Approximately 15 air changes an hour
Photoperiod: 12 hours light: 12 hours dark
Humidity: 68-70%
Test system
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- aqueous solution, administered undiluted.
- Controls:
- not required
- Amount / concentration applied:
- Amount applied: 0.1 ml
- Duration of treatment / exposure:
- 0.1 ml test substance (equivalent to 58 mg active salt) was instilled into the conjunctival sac of the right eye of each animal.
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- Three
- Details on study design:
- Comment: other: No indication that eye was rinsed.
Responses were evaluated 1, 24, 48 and 72 hours after dosing.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The test substance produced no evidence of an ocular irritation in any rabbit. A dulling of the normal lustre of the cornea was observed in all three rabbits at the one hour reading, accompanied in one rabbit by iritis. A diffuse crimson-red colouration of the conjunctivae accompanied by slight or distinct swelling with partial eversion of the eyelids was observed in two rabbits at this reading. Mild conjunctival inflammation and swelling was observed in the remaining animal. The reactions had reversed in all three animals by the 24 hour reading.
- Other effects:
- None reported.
Any other information on results incl. tables
CORNEA
No scored effects, but dulling of the cornea was observed in
all 3 animals, 1 hour after dosing. Total score 0.
IRIS
Score 1 in 1 animal, 1 hour after dosing. Total score 1.
CONJUCTIVAL REDNESS
Score 2 in 2 animals and score 1 in the third, 1 hour after
dosing. Total score 5.
CONJUNCTIVAL CHEMOSIS
Score 2 in 1 animal and score 1 in 2 animals, 1 hour after
dosing. Total score 4.
From 24 hours after dosing, no abnormal symptoms observed
any animal.
Group total score = 10.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the eye irritation study with DTPMP (5-7Na), conducted according to OECD Test Guideline 405 and in compliance with GLP, DTPMP (5-7Na) was concluded to be not irritating to the eyes of rabbits.
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.
