Registration Dossier
Registration Dossier
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EC number: 267-956-0 | CAS number: 67953-76-8
Toxicological information
Skin sensitisation
Currently viewing:
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
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- See read-across justification in IUCLID Section 13
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Clinical observations:
- erythema, grade 1 - slight redness
- 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
- Clinical observations:
- erythema, grade 1 - slight redness, reversible within 72 hours
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Clinical observations:
- erythema, grade 1 - slight redness
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- erythema, grade 1 - slight redness, reversible within 72 hours
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Reading:
- 2nd reading
- Group:
- positive control
- Remarks on result:
- not measured/tested
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: 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:
- Sodium Salts of (1-Hydroxyethylidene)bisphosphonic acid (2-3 Na:1)
- EC Number:
- 701-238-4
- Molecular formula:
- HEDP-2Na C2H6Na2O7P2 HEDP-3Na C2H5Na3O7P2
- IUPAC Name:
- Sodium Salts of (1-Hydroxyethylidene)bisphosphonic acid (2-3 Na:1)
- Test material form:
- not specified
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Not specified
- Females nulliparous and non-pregnant: Not specified
- Microbiological status of animals, when known: Not specified
- Age at study initiation: Not specified
- Weight at study initiation: Median body weight for the test group: 403 grams; Median body weight for the control group: 402 grams. No further details available.
- Housing: Not specified
- Diet: Not specified
- Water: Not specified
- Acclimation period: Not specified
- Indication of any skin lesions: Not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not specified
- Humidity (%): Not specified
- Air changes (per hr): Not specified
- Photoperiod (hrs dark / hrs light): Not specified
- IN-LIFE DATES: Not specified
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 animals for the test group and 20 animals for the control group.
- Details on study design:
- RANGE FINDING TESTS: Not specified
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Initially, 6 injections were performed (symmetrically and simultaneously). A week later, a topical induction was performed.
- Exposure period: A week
- Test groups: Not specified
- Control group: Not specified
- Site: Around the shoulder blades
- Frequency of applications: Initially, 6 injections were performed simultaneously followed by a topical induction a week later consisting of a 5% mixture in Vaseline, under a 2 x 4 cm piece of filter paper.
- Duration: The occlusive covering covered the site of topical induction for 48 hours
- Type of covering: Occlusive covering of watertight plastic and an elastic bandage.
- Concentrations:
2 x 0.1 ml Freund's Adjuvant (foremost two sites)
2 x 0.1 ml 5% aqueous solution of test substance (middle two sites)
2 x 0.1 ml Mixture (1:1) of 5% aqueous solution of test substance and Freund's Adjuvant (hindmost two sites).
As the concentration of the test substance is not clear, there is no evidence that this induction dose was irritating.
B. CHALLENGE EXPOSURE
- No. of exposures: One
- Day(s) of challenge: 14 days
- Exposure period: Appearing to be 21 hours (not clearly stated). 21 hours after the challenge, the area was re-shaved and remaining test substance was carefully removed with ether.
- Test groups: Not specified
- Control group: Not specified
- Site: 5 x 5 cm area around the flanks
- Type of covering: A 2 x 2 cm piece of filter paper, no occlusive covering appears to have been applied at this stage.
- Concentrations: 25 % mixture in Vaseline
- Evaluation (hr after challenge): 3 hours
OTHER: Areas were shaved or re-shaved prior to the application of the test substance.
1st application: Induction 5 % intracutaneous
2nd application: Induction 5 % occlusive epicutaneous
3rd application: Challenge 25 % semiocclusive - Positive control substance(s):
- not specified
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
- Clinical observations:
- erythema, grade 1 - slight redness
- 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
- Clinical observations:
- erythema, grade 1 - slight redness, reversible within 72 hours
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Clinical observations:
- erythema, grade 1 - slight redness
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- erythema, grade 1 - slight redness, reversible within 72 hours
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Reading:
- 2nd reading
- Group:
- positive control
- Remarks on result:
- not measured/tested
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 according to any OECD Test Guideline and pre-GLP, HEDP (2-3Na) is not sensitising to the skin of guinea pigs.
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