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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:
No data (report dated 24 May 1977)
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable published method available at the time of the study.

Data source

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

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Protocol as described by Magnusson B and Kligman AM (Journal of Investigative Dermatology (1969), 52, 268-276)
GLP compliance:
not specified
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): tetraammine platinous chloride
- Substance type: white powder
- Physical state: solid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: stored in plastic container; no further details
- Other:

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: albino
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Porcellus Animal Breeding Limited
Heathfield
Surrey, UK
- Age at study initiation: no data
- Weight at study initiation: 300-350 g
- Housing: individual
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 ± 1
- Humidity (%): 50-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): “controlled”

IN-LIFE DATES: From: To:

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
water
Challenge
Route:
epicutaneous, occlusive
Vehicle:
water
No. of animals per dose:
10 males
Details on study design:
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: one by injection; one by topical application 1 week later
- Exposure period:
- Test groups: one
- Control group: no data
- Site: shoulder region
- Frequency of applications: once
- Duration: topical application, 48 hr
- Concentrations: 5% by injection; neat for topical application

B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: 14 days after topical induction
- Exposure period: 24 hr
- Test groups: one
- Control group: no data
- Site: flank
- Concentrations: neat
- Evaluation (hr after challenge): 24 and 48 hr

OTHER:

Positive control substance(s):
not required

Results and discussion

In vivo (non-LLNA)

Results
Reading:
other: 1st and 2nd readings
Hours after challenge:
24
Group:
test group
Dose level:
Challenge dose – neat
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No data
Remarks on result:
other: Reading:

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Tetraammine platinous chloride did not induce sensitization in a GPMT, in which a group of ten male guinea pigs were dermally challenged with the neat test compound following a two-stage induction with 5% by intradermal injection and topical application of the neat substance.
Executive summary:

The skin sensitising potential of tetraammine platinous dichloride was investigated in a guinea pig maximisation test conducted according the method of Magnusson and Kligman (as described in OECD Test Guideline 406).

 

A group of ten male animals were treated in the shoulder area by intradermal injection with 5% of the test compound, followed 7 days later by a 48-hr topical occluded application of the neat substance. A challenge dose of the neat substance was applied topically to the flank region 14 days later and examined for sensitisation reactions after 24 and 48 hr.

 

No positive reactions were evident. Hence, tetraammine platinous chloride did not induce sensitisation in this test.

 

Based on the results of this study, no classification for skin sensitisation is required according to EU CLP criteria (EC 1272/2008).