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Toxicological information

Skin sensitisation

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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study.
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): nickel oxide
- Analytical purity: 99.99 %

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: individually housed in wire mesh cages in an environmentally-controlled room
- Food: ad libitum
- Water: 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:
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 group
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 group
Dose level:
0.2 g
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 g. 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 guideline 406. 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 plain 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.