Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
3 days; no data on dates (Report date January 1977)
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Not according to modern guidelines. No control sites; test material not washed off after the 24 hr exposure period.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: US Federal register Vol. 38, No. 187, section 1500:41 (1973)
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:

-Name of test material (as cited in study report): tetrammineplatinous chloride
- Substance type: no data
- 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: no data
- Other:

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:

TEST ANIMALS
- Source: “recognised breeders”
- Age at study initiation: 12-14 weeks
- Weight at study initiation: about 2.2 kg
- Housing: Individually housed; type of cage not specified
- Diet (e.g. ad libitum): conventional diet, ad libitum
- Water (e.g. ad libitum): filtered water, ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-19
- Humidity (%): 50-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): natural lighting

IN-LIFE DATES: From: To:

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: shaved & abraded
Vehicle:
not specified
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg (no data if applied as the powder or made into a paste

Duration of treatment / exposure:
24 hr
Observation period:
24 and 72 hr
Number of animals:
Six females
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm each of shaved dorsal skin and shaved and abraded dorsal skin
- % coverage: no data
- Type of wrap if used: applied on gauze held in place with “Sleek” adhesive tape. Entire trunk covered with an elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data; presumably substance not removed
- Time after start of exposure:

SCORING SYSTEM: assessed for primary irritation index at 24 and 72 hr. Scores for erythema/eschar formation and edema for both intact and abraded skin at both time points were totalled and divided by 24 to give the primary irritation index.
Primary irritation index Classification
0 non-irritant
> 0-2 mild irritant
> 2-5 moderate irritant
> 5-8 severe irritant

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: Mean of 24- and 72-hr time points
Score:
2.8
Max. score:
8
Reversibility:
other: not assessed; animals only kept for 48 hrs after removal of the patch.
Remarks on result:
other: Score is the mean for intact and abraded skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: Mean of 24- and 72-hr time points
Score:
5
Max. score:
16
Reversibility:
other: not assessed; animals only kept for 48 hrs after removal of the patch.
Remarks on result:
other: Score is the mean for intact and abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: Mean of 24- and 72-hr time points
Score:
6.2
Max. score:
16
Reversibility:
other: not assessed; animals only kept for 48 hrs after removal of the patch.
Remarks on result:
other: Score is the mean for intact and abraded skin
Other effects:
No indication that systemic effects were assessed.

Any other information on results incl. tables

Table 1: Individual rabbit results

 Rabbit No.  Time/hr  Erythema    Oedema  
     Abraded skin  Intact skin  Abraded skin  Intact skin
 1  24  1  1  2  2
   72  1  1  1  1
 2  24  1  1  1  1
   72  1  1  1  1
 3  24  2  2  2  2
   72  2  2  2  2
 4  24  1  1  2  2
   72  1  1  1  1
 5  24  1  1  3  1
   72  1  1  1  0
 6  24  1  1  2  2
   72  2  2  2  2

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
In a US guideline study, moderate irritation was observed following a single 24-hr semi-occluded application of tetraammine platinous chloride to the intact or abraded skin of three rabbits.
Executive summary:

In a US guideline study, the irritant potential of tetraammine platinous chloride was assessed on the intact and abraded skin of six female New Zealand white rabbits.

 

The test substance (0.5 g) was applied for 24-hr under semi-occlusion and assessed immediately upon removal of the patch as well as 48 hr later. Residual test material was not washed off the skin during this period. Moderate irritation was observed at both time points. Similar scores for both erythema/eschar formation and edema were reported for intact and abraded skin. The primary irritation index was calculated to be 2.8.

 

Mean erythema/eschar and oedema scores were below 2.3 for all six animals. However, the effects were only observed to be reversible in one animal within the 48-hr observation period.

 

Based on the results of this study, tetraammine platinous chloride should be classified as a skin irritant (category 2) according to EU CLP criteria (EC 1272/2008).