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EC number: 231-131-3 | CAS number: 7440-22-4
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- 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:
- Substance considered to fall withing the scope of the read-across 'Nanosilver: Justification of a read-across approach for human health hazard endpoints' (document attached in IUCLID section 13 - "CSR Annex 11 - Weight of Evidence Justification for Silver metal - human health endpoints).
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1999-09-09 to 1999-10-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study
- Justification for type of information:
- Weight of evidence approach described in 'Silver metal (massive and powder): Weight of Evidence' (document attached in IUCLID section 13 - "CSR Annex 11 - Weight of Evidence Justification for Silver metal - human health endpoints).
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- no
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The study was performed before the LLNA method was the first choice method for this endpoint
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Davidson´s Mill Farm, South Brunswick, NJ, USA
- Age at study initiation: young adult
- Weight at study initiation: males 242-316g, females 251-340g
- Housing: group housed in suspended stainless steel caging with mesh floors which conform to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals DHEW (NIH). Litter paper was placed beneath the cage and was changed at least three times per week.
- Diet (e.g. ad libitum): Pelleted Purina Guinea Pig Chow # 5025
- Water (e.g. ad libitum): filtered tap water was supplied ad libitum by automatic water dispensing system
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-26°C
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- distilled
- Concentration / amount:
- 75% w/w solution of the test substance in distilled water
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- distilled
- Concentration / amount:
- 75% w/w solution of the test substance in distilled water
- No. of animals per dose:
- - Number of animals: 34
- Number of Groups: 3
- Number of animals per group: Preliminary Irritation Group: 4/ Test Group: 20/ Test Naive Control Group: 10 - Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: three weeks
- Test groups: 20 animals
- Control group: 10 animals
- Site: left site of the dorsal area
- Frequency of applications: once a week for three weeks
- Duration: 6 hours
- Concentrations: 0.4ml of 75% w/w solution of test substance in distilled water
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 27 days after the first induction dose
- Exposure period: 2 days
- Test groups: 20 animals
- Control group: 10 animals
- Site: right side of the dorsal area
- Concentrations: 0.4ml of 50% w/w solution of the test substance in distilled water
- Evaluation (hr after challenge): 24hr and 48 hr - Challenge controls:
- naive control: 50 % w/w test solution
historical positive control: 0.04% DNCB in avetone
historical positive naive control: 0.04% DNCB in acetone - Positive control substance(s):
- yes
- Remarks:
- 1-Chloro-2,4-Dinitrobenzene (DNCB)
- Positive control results:
- Induction Phase:
Very faint to severe erythema (0.5-3) was noted
Challenge Phase:
Eight of ten positive control animals exhibited signs of a sensitization response (faint to moderate rythema [1-2] 24 and /or 48h after challenge - Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 % w/w
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- very faint erythema (0.5)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 % w/w. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: very faint erythema (0.5).
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 % w/w
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- very faint erythema (0.5)
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 % w/w. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: very faint erythema (0.5).
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 % w/w
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- very faint erythema (0.5)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: naive control group. Dose level: 50 % w/w. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: very faint erythema (0.5). The negative: naive control group
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 % w/w
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- very faint erythema (0.5)
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: naive control group. Dose level: 50 % w/w. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: very faint erythema (0.5).
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.04% DNCB in acetone
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- faint to moderate erythema (1-2)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.04% DNCB in acetone. No with. + reactions: 8.0. Total no. in groups: 10.0. Clinical observations: faint to moderate erythema (1-2).
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.04% DNCB in acetone
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- faint to moderate erythema (1-2)
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.04% DNCB in acetone. No with. + reactions: 7.0. Total no. in groups: 10.0. Clinical observations: faint to moderate erythema (1-2).
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.04% DNCB in acetone
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- very faint erythema (0.5)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: positive naive control group. Dose level: 0.04% DNCB in acetone. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: very faint erythema (0.5).
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.04% DNCB in acetone
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no irritation
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: positive naive control group. Dose level: 0.04% DNCB in acetone. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no irritation.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Based on these findings and on the evaluation system used, Axenohl is not considered to be a contact sensitizer.
Data source
Materials and methods
Test material
- Reference substance name:
- Silver
- EC Number:
- 231-131-3
- EC Name:
- Silver
- Cas Number:
- 7440-22-4
- Molecular formula:
- Ag
- IUPAC Name:
- Silver
- Test material form:
- solid: nanoform, surface-treated
- Remarks:
- paste of nanomaterial
- Details on test material:
- Spherical particles
Particle size distribution (primary particles; number-based): Min = 11 nm, D25 = 25 nm, D50 = 34 nm, D75 = 48 nm, Max = 161 nm
Volume specific surface area: 150 m2/cm3
Zeta potential: -23.3 mV
Constituent 1
Results and discussion
- Positive control results:
- Induction Phase:
Very faint to severe erythema (0.5-3) was noted
Challenge Phase:
Eight of ten positive control animals exhibited signs of a sensitization response (faint to moderate rythema [1-2] 24 and /or 48h after challenge
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 % w/w
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- very faint erythema (0.5)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 % w/w. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: very faint erythema (0.5).
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 % w/w
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- very faint erythema (0.5)
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 % w/w. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: very faint erythema (0.5).
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 % w/w
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- very faint erythema (0.5)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: naive control group (negative control). Dose level: 50 % w/w. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: very faint erythema (0.5).
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 % w/w
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- very faint erythema (0.5)
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: naive control group (negative control). Dose level: 50 % w/w. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: very faint erythema (0.5).
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.04% DNCB in acetone
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- faint to moderate erythema (1-2)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.04% DNCB in acetone. No with. + reactions: 8.0. Total no. in groups: 10.0. Clinical observations: faint to moderate erythema (1-2).
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.04% DNCB in acetone
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- faint to moderate erythema (1-2)
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.04% DNCB in acetone. No with. + reactions: 7.0. Total no. in groups: 10.0. Clinical observations: faint to moderate erythema (1-2).
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.04% DNCB in acetone
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- very faint erythema (0.5)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: positive naive control group. Dose level: 0.04% DNCB in acetone. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: very faint erythema (0.5).
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.04% DNCB in acetone
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no irritation
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: positive naive control group. Dose level: 0.04% DNCB in acetone. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no irritation.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Based on these findings and on the evaluation system used, Axenohl is not considered to be a contact sensitizer.
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