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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27 September - 1 November 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study, to GLP, with slight deviations from the recommended temperature and humidity range

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
deviation of the temperature and humidity range
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
deviation of the temperature and humidity range
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
not specified
Qualifier:
according to
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries, JMAFF (2000), including the most recent partial revisions
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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): Platinum (2+) tetraammine (SP-4-1) diacetate
- Substance type: No data
- Physical state: white crystalline powder
- Analytical purity: 95.2%
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: Pt (48.75%), Cl (0.029%)
- Isomers composition: Not applicable
- Purity test date: No data
- Lot/batch No.: GB 379
- Expiration date of the lot/batch: 28 June 2005
- Stability under test conditions: stable under storage conditions
- Storage condition of test material: room temperature in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: 7-9 weeks
- Weight at study initiation: 1.30-1.57 kg
- Housing: individually in cages with perforated floors
- Diet (e.g. ad libitum): 100g/day of standard laboratory rabbit diet
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 5 days before treatment initiation

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16.7-22.4 (specified range is 20 ± 3 deg C, a deviation at the lower end of the recommended temperature range of only 0.3 deg C is not expected to have affected the validity of the results)
- Humidity (%): 33-74 (recommended range is 30-70%, this deviation at the upper end of the recommended range of only 4% is not expected to affect the validity of the results)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 27 September 2004 To: 1 November 2004

Test system

Vehicle:
not specified
Controls:
other: the other eye of each animal remained untreated and served as the reference control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 92.7 mg
- Concentration (if solution): Not applicable

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Not applicable
- Lot/batch no. (if required): No data
- Purity: No data
Duration of treatment / exposure:
14 days
Observation period (in vivo):
Observed at 1, 24, 48 and 72 hr, and 7 and 14 days after instillation.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): treated eye not rinsed
- Time after start of exposure: not applicable

SCORING SYSTEM: The irritation was assessed according to the Draize classification system based on the extent of effects seen on the cornea, iris and conjunctiva in each animal.

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: corneal opacity
Basis:
mean
Time point:
other: 24-72 hours
Score:
0
Max. score:
4
Remarks on result:
other: reversibility not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72 hours
Score:
0
Max. score:
2
Remarks on result:
other: reversibility not applicable
Irritation parameter:
other: conjunctivae redness score
Basis:
mean
Time point:
other: 24-72 hours
Score:
2.2
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-72 hours
Score:
1.1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Irritation of the eye was limited to the conjunctivae and consisted of redness, chemosis and discharge (highest scores observed in an individual rabbit were 3, 2, 2 respectively). The irritation had completely resolved within 14 days.
Other effects:
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

 Animal

 Mean 24 -72 hours         

   Corneal opacity  Iris  Conjunctivae   
       Redness  Chemosis
 1  0.0  0.0  2.0  1.3
 2  0.0  0.0  2.3  1.0
 3  0.0  0.0  2.3  1.0
 Mean  0.0  0.0  2.2  1.1

Table 1: Mean value eye irritation scores

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
In an OECD guideline study, to GLP, platinum (2 +) tetraammine (SP-4 -1) diacetate produced conjunctival effects following instillation of the test material (93 mg) to the eyes of three male rabbits. The irritation had completely resolved within 14 days.
Executive summary:

In an OECD guideline study (TG 405), conducted according to GLP, approximately 93 mg of platinum (2 +) tetraammine (SP-4 -1) diacetate was instilled into one eye of each of three male New Zealand white rabbits. The other eye remained untreated and was used for control purposes.

Irritation of the conjunctivae, consisting of redness, chemosis and discharge (highest scores observed in an individual rabbit were 3, 2, 2 respectively) was observed in all three animals. The irritation had completely resolved within 14 days. No effects were seen on the iris or cornea. No corrosive effects were noted and there was no evidence of systemic toxicity. As the conjunctival redness score (calculated as mean of the scores at 24, 48 and 72 hr) was greater than or equal to 2 in all three animals, the test material met the criteria for classification as irritant category 2 according to EU CLP regulations.