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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not reported
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not applicable
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study conducted in 1977

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Ammonium hexachloroplatinate
- Substance type: yellow powder
- Physical state: solid
- Lot/batch No.: no data

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Porcellus animal breeding Ltd, Heathfield, Sussex, UK
- Weight at study initiation: 300-350 g
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17
- Humidity (%): 50-70

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: saline for the induction injection, and petroleum jelly for the topical applications (induction and challenge phase)
Concentration / amount:
Induction: intradermal injection of saturated solution in saline, followed by topical application at 50% w/w in petroleum jelly. Challenge phase: 1, 5 and 10% w/w test material in petroleum jelly.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: saline for the induction injection, and petroleum jelly for the topical applications (induction and challenge phase)
Concentration / amount:
Induction: intradermal injection of saturated solution in saline, followed by topical application at 50% w/w in petroleum jelly. Challenge phase: 1, 5 and 10% w/w test material in petroleum jelly.
No. of animals per dose:
10 females
Details on study design:
RANGE FINDING TESTS:
Four guinea-pigs were given topical applications of 10, 20, 50 and 100% of the test material in petroleum jelly, sites examined at 24 and 48 hrs.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Three pairs of simultaneous injections were made to the clipped skin with either 0.1 mL Freunds Complete Adjuvant (FCA), 0.1 mL test substance alone, or 0.05 ml of test substance with 0.05 mL FCA.
- Exposure period: One week after the injections (described above), the same area was clipped and shaved and a 4 x 2 cm patch of filter paper saturated with the test substance was applied to the previously injected area. This patch was secured by elastic adhesive bandage and left in position for 48 hrs.
- Test groups: 10 animals
- Control group: 4 animals (OECD guidelines recommend at least 5 animals)
- Site: shoulder
- Frequency of applications:
- Duration:
- Concentrations: Injection: 0.1 mL test material alone, or 0.05 ml test material with FCA. For the topical induction, 50% w/w in petroleum jelly.

B. CHALLENGE EXPOSURE
- No. of exposures: Animals were challenged two weeks after the topical induction with a 2 x 2 cm piece of filter paper saturated with the test substance.
- Exposure period: Patch held in place for 24 hours
- Test groups: 10 animals
- Control group: 4 animals
- Site: Flank
- Concentrations: 10% w/w in petroleum jelly. A second challenge (a further week later) was made with 1 and 5% dilutions in petroleum jelly
- Evaluation (hr after challenge): 24 and 48 hrs
Challenge controls:
Four guinea-pigs were treated with saline in place of the test substance at induction, but otherwise induction and challenge were the same as for the test animals (as described above)
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
10%
No. with + reactions:
8
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 8.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
10%
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 2.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%
No. with + reactions:
1
Total no. in group:
4
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10%. No with. + reactions: 1.0. Total no. in groups: 4.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10%
No. with + reactions:
1
Total no. in group:
4
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10%. No with. + reactions: 1.0. Total no. in groups: 4.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 4.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
1%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
1%
No. with + reactions:
0
Total no. in group:
4
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 4.0.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No skin sensitization reactions were seen in a guinea pig maximisation test, involving topical challenge with ammonium hexachloroplatinate at 5% in petroleum.
Executive summary:

Ten guinea pigs were administered ammonium hexachloroplatinate by intradermal injection (with and without FCA) in the shoulder, followed a week later by a topical application of the test material at 50% in petroleum jelly with an occluded patch test placed over the clipped and shaved injection site for 48 hours. Two weeks later the animals were challenged with the test material at 10% in petroleum jelly on the clipped flank (24-hour occluded patch test). The challenge site was evaluated 24 and 48 hrs after removal of the patch. Eight of the ten animals challenged with ammonium hexachloroplatinate at 10% in petroleum exhibited a positive reaction, but so too did one of the four controls (and two others had doubtful reactions). The study investigators concluded that the reaction was caused by irritation rather than sensitization. A week later, no positive reactions were seen when the animals were re-challenged with the test substance at 1 and 5% in petroleum, or in the corresponding controls at these lower concentrations.