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EC number: 231-165-9 | CAS number: 7440-57-5
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:
- 11 December 1998 to 08 January 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, available as unpublished report, accepted without restriction
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Principles of method if other than guideline:
- Also according to:
* "Biological evaluation of medical devices"
* ISO 10993-1: 1997, "Evaluation and testing"
* ISO 10993-10: 1995, (6.3) "Tests for irritation and sensitization"
* ISO 10993-12: 1996, "Sample preparation and reference material"
* DIN EN 30993-1: 1994 and DIN EN ISO 7405:1998 (5.2.2e) "Preclinical evaluation of biocompatibility of medical devices used in dentistry - Test methods" - GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Gold
- EC Number:
- 231-165-9
- EC Name:
- Gold
- Cas Number:
- 7440-57-5
- Molecular formula:
- Au
- IUPAC Name:
- gold(1+)
- Details on test material:
- Name of test material (as cited in study report): Ectectior Vision, dental alloy for the ceramic fused-to-metal technic
- Physical state: solid
- Composition of test material, percentage of components: Au 98.2%, Ti 1.7%, Ir 0.1%
- Lot/batch No.: 2974
- Expiration date of the lot/batch: none
- Stability under test conditions: Unlimited stable
- Storage condition of test material: at room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelman GmbH, D-33178 Borchen
- Age at study initiation: Not reported
- Weight at study initiation: 301 - 316 g
- Housing: Terluran cages on Altromin saw fiber bedding. Max caging group size: 10 animals.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): not reported
- Acclimation period: Under test conditions for one week.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 55 ± 10%
- Air changes (per hr): at least 10x / hour
- Photoperiod (hrs dark / hrs light): Artificial lighting, 12 hours light, 12 hours dark
IN-LIFE DATES: Not reported
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- Three pairs of 0.1 ml injections were administered, with 0, 100 and 50% concentration of test item in Freund's adjuvant complete. Topic application was a solid specimen of test item, dimensions 15 x 30 x 1 mm.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- Three pairs of 0.1 ml injections were administered, with 0, 100 and 50% concentration of test item in Freund's adjuvant complete. Topic application was a solid specimen of test item, dimensions 15 x 30 x 1 mm.
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS: Not reported
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1 interdermal, 1 topical
- Exposure period: Interdermal injections: Day 0, Topical: 48 hour patch (days 7 & 8)
- Test groups: 1
- Control group: 1
- Site: Shoulder region
- Frequency of applications: No repetition
- Duration: Topical: 48 hour patch
- Concentrations: Three pairs of 0.1 ml injections were administered, with 0, 100 and 50% concentration of test item in Freund's adjuvant complete. Topic application was a solid specimen of test item, dimensions 15 x 30 x 1 mm.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 20
- Exposure period: 24 hours
- Test groups: 1
- Control group: 1
- Site: Left flank
- Concentrations: Solid specimen of test item, dimensions 15 x 30 x 1 mm.
- Evaluation (hr after challenge): 24, 48 & 72 hours - Challenge controls:
- 5 animals were inducted with injections lacking the test item.
- Positive control substance(s):
- yes
- Remarks:
- Mercaptobenzothiazole
Results and discussion
- Positive control results:
- see table 1
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
Any other information on results incl. tables
Table 1 - Frequency of Sensitization in Positive Control Animals
| Erythema Grade | Oedema Grade | ||||||||||
| Time after challenge treatment (hours) | E0 | E1 | E2 | E3 | E4 | O0 | O1 | O2 | O3 | O4 | % |
| 24 | 4 | 4 | 2 | 10 | 60 | ||||||
| 48 | 4 | 3 | 3 | 10 | 60 | ||||||
| 72 | 8 | 2 | 10 | 20 | |||||||
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- A Guinea-Pig Maximisation test showed that gold is not a skin sensitizer.
- Executive summary:
A GLP-compliant, OECD Guideline (406) Guinea-Pig Maximisation test showed that gold is not a skin sensitizer.
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