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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27 May 1997 - 6 June 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study, to GLP, minor deviation from the recommended humidity range and the use of an occlusive patch

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
relative humidity was above the range stated in the protocol on two occassions for approximately one hour each; guideline recommends the use of a semi-occlusive dressing
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
relative humidity was above the range stated in the protocol on two occassions for approximately one hour each; guideline recommends the use of a semi-occlusive dressing
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Tetramine platinum hydrogencarbonate
IUPAC Name:
Tetramine platinum hydrogencarbonate
Constituent 2
Reference substance name:
123439-82-7
Cas Number:
123439-82-7
IUPAC Name:
123439-82-7
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Tetramine platinum hydrogencarbonate
- Substance type: No data
- Physical state: white powder
- Analytical purity: >99.9%
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: Tetramine platinum hydrogencarbonate (>99.9%)
- Isomers composition: Not applicable
- Purity test date: No data
- Lot/batch No.: 02/95
- Expiration date of the lot/batch: 31/12/1999
- Stability under test conditions: stable throughout the experimental period of the study
- Storage condition of test material: closed container at room temperature
- Other: pH value about 8 (concentrated solution)

Test animals

Species:
rabbit
Strain:
other: white russian (albino)
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: ASTA Medica AG, D-33790 Halle-Westfalen
- Age at study initiation: 20-35 months
- Weight at study initiation: 2.39-3.01 kg
- Housing: stainless steel cages with grating floor, one animal per cage
- Diet (e.g. ad libitum): 120 g/animal each day (ssniff K-Z, complete diet for rabbits-breeding)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least one day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5-20 deg C
- Humidity (%): 40-80% (recommended humidity range is 30-70%, this slight deviation is not expected to affect the study findings)
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 27 May 1997 To: 6 June 1997

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
other: test substance was moistened with water to ensure a tight contact with the skin
Controls:
other: the opposite area of dorsal skin was treated in the same way but without test substance
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): Not applicable

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.14 mL demineralized water
- Concentration (if solution): Not applicable
- Lot/batch no. (if required): No data
- Purity: No data
Duration of treatment / exposure:
4 hours
Observation period:
Observed at 1, 24, 48 and 72 hr (two animals) and daily until day 9 (one animal) after application
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6.25 cm squared
- % coverage: No data
- Type of wrap if used: Acrylastic bandage No. 2408, width 8 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Gentle washing as at the end of the exposition time
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize irritation index

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 1-72 hours
Score:
0.3
Max. score:
8
Reversibility:
fully reversible within: 9 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1-72 hours
Score:
0.17
Max. score:
4
Reversibility:
fully reversible within: 9 days
Remarks on result:
other: includes eschar
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1-72 hours
Score:
0.08
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritant / corrosive response data:
Erythema and edema (both very slight) were observed in one animal, on day 2-8 and day 3-5, respectively. Eschar formation was also detected in the same animal on day 5, this started to peel on day 6 and had completely disappeared by day 9.
Other effects:
The general condition of the animals was not affected. Systemic toxic effects did not occur after dermal application of the test substance.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In a guideline study (OECD TG 404), to GLP, tetraammineplatinum(II) hydrogen carbonate was very slightly irritating to the clipped skin of one of three rabbits following a 4-hr occlusive application; no irritation potential was observed in the other two animals.
Executive summary:

In an OECD Test Guideline 404 study, conducted according to GLP, a 4 hour, occlusive application of tetraammineplatinum(II) hydrogencarbonate (0.5 g moistened with 0.14 mL water) was made to the clipped skin of three male white Russian rabbits. After 4 hours, the dressings were removed and the skin sites assessed for signs of irritation (edema and erythema/eschar) at 1, 24, 48 and 72 hours.

 

Erythema (including eschar) and edema (both very slight) were observed in one of the three animals after 48 and 72 hr respectively. Effects were reversible within 9 days of application. No signs of irritation were apparent in the other two animals. The test material produced a primary dermal irritation index of 0.3 [maximum total score = 8.0] (mean of scores at 1 -72 hr after application)and was classified as non-irritant to rabbit skin according to the Draize classification system. Systemic toxicity was not observed after dermal application of the test substance and the general condition of the animals was unaffected.

 

Based on the results of this study, the test material does not require classification as a skin irritant according to EU CLP criteria (EC 1272/2008).