Registration Dossier
Registration Dossier
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EC number: 215-851-5 | CAS number: 1429-50-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Buehler test
- GLP compliance:
- not specified
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Buehler test method.
Test material
- Reference substance name:
- EDTMP-xNa
- IUPAC Name:
- EDTMP-xNa
- Reference substance name:
- [ethylenebis[nitrilobis(methylene)]]tetrakisphosphonic acid, sodium salt
- EC Number:
- 244-742-5
- EC Name:
- [ethylenebis[nitrilobis(methylene)]]tetrakisphosphonic acid, sodium salt
- Cas Number:
- 22036-77-7
- Molecular formula:
- C6H20N2O12P4.xNa
- Test material form:
- not specified
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% test material. Positive control induction in 80% ethanol, rechallenge in acetone as vehicle (concentration not reported).
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% test material. Positive control induction in 80% ethanol, rechallenge in acetone as vehicle (concentration not reported).
- No. of animals per dose:
- The positive control group and the test material group consisted of 5 males and 5 females, and these animals were treated during the induction and challenge phases of this study. A third group was included which consisted of 3 males and 3 females, and these animals were treated only during the challenge phase to assess whether the challenge concentration was irritating.
- Details on study design:
- During the induction phase, the test material was applied for 6 hours and the skin was wiped free of any excess material. The treatment was repeated once a week for three weeks, for a total of three exposures. After a two week rest period, animals were treated during the first challenge phase at a new site with no previous application of test material.
- Challenge controls:
- Yes
- Positive control substance(s):
- yes
- Remarks:
- DNCB
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- rechallenge
- Group:
- positive control
- Dose level:
- acetone as vehicle
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- greater of the 24/48 hour score
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- 24/48 hour reading
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Group:
- other: challenge (irritation) control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
0.3 ml of the test material was applied at induction and challenge as a 100% solution.
Dequest 2046 is known to have 35.7% active salt content at pH 6 -8, and a specific gravity of 1.3 -1.36 g/ cm3.
The pKa of the salt at pH 7.3 is estimated to be 6. The conversion factor to determine the salt to acid equivalent for mass for EDTMP-6Na salt is 0.768.
Therefore, based on the known active salt proportion of the substance it is calculated that the at application to animal skin amount of active salt is 400 mg, and active acid 300 mg.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material was found not sensitising in a Buehler test, conducted according to an appropriate test protocol but not in compliance with GLP.
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