Registration Dossier
Registration Dossier
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EC number: 701-237-9 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
- Principles of method if other than guideline:
- Method: other: variation of Magnusson and Kligman method
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Guinea Pig Maximisation test method.
Test material
- Reference substance name:
- Etidronic acid
- EC Number:
- 220-552-8
- EC Name:
- Etidronic acid
- Cas Number:
- 2809-21-4
- Molecular formula:
- C2H8O7P2
- IUPAC Name:
- (1-hydroxyethylidene)bisphosphonic acid
- Test material form:
- not specified
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: water, Freund's Adjuvant (intradermal induction) and Vaseline (topical induction and challenge)
- Concentration / amount:
- 5% induction, 25% challenge
Challenge
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: water, Freund's Adjuvant (intradermal induction) and Vaseline (topical induction and challenge)
- Concentration / amount:
- 5% induction, 25% challenge
- No. of animals per dose:
- 20 test and 20 controls
- Details on study design:
- 1st application: Induction 5 % intracutaneous
2nd application: Induction 5 % occlusive epicutaneous
3rd application: Challenge 25 % semiocclusive
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
TEST SUBSTANCE GROUP RESPONSES
24 hours: 8 animals (erythema: grade 1 - slight redness)
48 hours: 5 animals (erythema: grade 1 - slight redness)
72 hours: 0 animals displaying symptoms
CONTROL GROUP RESPONSES
24 hours: 6 animals (erythema: grade 1 - slight redness)
48 hours: 2 animals (erythema: grade 1 - slight redness)
72 hours: 0 animals displaying symptoms
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a guinea-pig maximisation study (reliability score 2), not conducted to GLP, sodium salt of HEDP was not sensitising to the skin.
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