Registration Dossier
Registration Dossier
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EC number: 700-710-7 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Nickel monoxide
- EC Number:
- 215-215-7
- EC Name:
- Nickel monoxide
- Cas Number:
- 1313-99-1
- IUPAC Name:
- oxonickel
- Details on test material:
- - Name of test material (as cited in study report): nickel oxide
- Analytical purity: 99.99%
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Hartley-derived
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Wilmington, MA.
- Housing: indivdually housed in wire mesh cages in an environmentally-controlled room
- Food: ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- propylene glycol
- Concentration / amount:
- 0.2 g NiO
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- 0.2 g NiO
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:
Day 1 0.1 mL injection
Day 8 0.3 mL topical, occluded, 48 hr
- Site: flank
- Concentrations: 1% w/v
B. CHALLENGE EXPOSURE
- No. of exposures: 1 challenge on day 22
- Day(s) of challenge: 1 day
- Exposure period: 1 day
- Site: flank
- Concentrations: 0.2 g
- Evaluation (hr after challenge): 24 hr, 48 hr - Challenge controls:
- propylene glycol (negative)
- Positive control substance(s):
- yes
- Remarks:
- 1-chloro-2,4,-dinitrobenzene
Study design: in vivo (LLNA)
- Vehicle:
- not specified
- Concentration:
- Not applicable.
- No. of animals per dose:
- Not applicable.
- Details on study design:
- Not applicable.
- Statistics:
- Not reported.
Results and discussion
- Positive control results:
- Not legible.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.2 g
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.2 g. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.2
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.2. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100% vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100% vehicle. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100% vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100% vehicle. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1% DNBC
- No. with + reactions:
- 6
- Total no. in group:
- 6
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.1% DNBC. No with. + reactions: 6.0. Total no. in groups: 6.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1% DNBC
- No. with + reactions:
- 6
- Total no. in group:
- 6
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.1% DNBC. No with. + reactions: 6.0. Total no. in groups: 6.0.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Not applicable.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Not applicable.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The authors concluded that under the conditions of this study, NiO failed to cause sensitization in female albino guinea pigs.
- Executive summary:
Food & Drug Research Laboratories, Inc. (FDRL) conducted a guinea pig maximization test (GPMT) according to OECD Test #406 – Skin Sensitization. In this study, nickel sulfate was used as the initial sensitizing agent and NiO was used for challenge. Briefly, ten female Hartley-derived guinea pigs were shaved and each injected intradermally with 0.1 mL 1% (w/v) nickel sulfate in distilled water and 0.1 mL Freund’s complete adjuvant (FCA). Each animal received a total of 6 injections (i.e. 3 paired injections) flanking the midline. Eight days later, each site was further sensitized by a topical exposure to nickel sulfate (0.3 mL 5% w/v) and occluded for 48 hr. On day 22 after the initial sensitization injections, virgin sites along the ventral midline and original injection sites were challenged and occluded for 24 hr with nickel sulphate, 0.2 g NiO moistened with propylene glycol, or propylene glycol. These challenges were scored for erythema and edema via the Draize method at 24 and 48 hr after removal. Clinical signs, bodyweight, and mortality were also examined. No mortality was observed, and all other effects were considered spontaneous and incidental to the study. The erythema scores in animals challenged with NiO were 0 at 24 and 48 hr for animals previously sensitized with nickel sulfate or vehicle controls. The authors concluded that under the conditions of this study, NiO failed to cause sensitization in female albino guinea pigs while nickel sulfate did cause dermal contact sensitization.
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