Registration Dossier
Registration Dossier
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EC number: 247-019-2 | CAS number: 25481-21-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from peer reviewed journals
Data source
Reference
- Reference Type:
- publication
- Title:
- Final report on the safety assessment of EDTA and its salts
- Author:
- Cosmetic Ingredient Review Expert Panel
- Year:
- 2 002
- Bibliographic source:
- International Journal of Toxicology,2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- To determine the allergenic potential of the test chemical in guinea pigs
- GLP compliance:
- not specified
- Type of study:
- not specified
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- Disodium dihydrogen ethylenediaminetetraacetate
- EC Number:
- 205-358-3
- EC Name:
- Disodium dihydrogen ethylenediaminetetraacetate
- Cas Number:
- 139-33-3
- Molecular formula:
- C10-H16-N2-O8.2Na
- IUPAC Name:
- 2-[2-[bis(carboxymethyl)amino]ethyl-(carboxymethyl)amino]acetic acid
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): Disodium dihydrogen ethylenediaminetetraacetate
- Molecular formula: C10H14N2Na2O8
- Molecular weight: 336.208 g/mol
- Substance type: Organic
- Physical state: Solid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male
- Details on test animals and environmental conditions:
- no data available
Study design: in vivo (non-LLNA)
Induction
- Route:
- other: intracutaneous
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- First day 0.1 ml, then 0.2 ml on alternate days
- Day(s)/duration:
- 10 days
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- other: intracutaneous
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.1 ml
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 5 male
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 10 days
- Test groups: 5
- Control group: no data available
- Site: no data
- Frequency of applications: First day 0.1 ml, then 0.2 ml on alternate days
- Duration: First day 0.1 ml, then 0.2 ml on alternate days
- Concentrations: First day 0.1 ml, then 0.2 ml on alternate days
B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge: 2 weeks after last induction injection
- Exposure period: 24 hours
- Test groups: 5
- Control group: no data
- Site:
- Concentrations: 0.1 ml
- Evaluation (hr after challenge): 24 hours later - Challenge controls:
- no data available
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 ml
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No dermal reactions observed
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- No dermal reactions were observed 24 hours after the challenge exposure. Hence the test chemical was considered to be not sensitizing to skin.
- Executive summary:
The allergenic potential of the test chemical was determined in guinea pigs. 5 male guinea pigs were injected intra cutaneously with a volume of 0.1 ml of the test chemical on day 1, then 9 volumes of 0.2 ml of the test chemical on alternate days.
2 weeks after last induction injection, the guinea pigs were challenged with 0.1 ml of the test chemical via intracutaneous injection. The sites were evaluated 24 hours later for signs of dermal sensitization.
No dermal reactions were observed 24 hours after the challenge exposure. Hence the test chemical was considered to be not sensitizing to skin.
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