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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:
No data (Report date March 1977)
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Not carried out to modern guidelines; not according to GLP

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 37, No. 83, 28 April 1972, 191. 12
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): tetrammine 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: no data (supplied in plastic container)
- Other:

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: “recognised breeder”
- Age at study initiation: 12-14 weeks
- Weight at study initiation: mean 1.9 kg
- Housing: caged singly; no further data
- Diet (e.g. ad libitum): conventional diet; ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 ± 2
- Humidity (%): 50-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): natural lighting

IN-LIFE DATES: From: To:

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: yes, concurrent no treatment to left eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg into the right eye

VEHICLE
none
Duration of treatment / exposure:
Group 1: 5 min (5 animals); Group 2: 24 hr (3 animals)
Observation period (in vivo):
1, 24, 48, and 72 hr, then daily for a further 4 days
Number of animals or in vitro replicates:
8 females (5 with 5 min exposure (Group 1); 3 with 24 hr exposure (Group 2))

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Remarks:
Group 1 - eyes rinsed after 5 mins
Basis:
mean
Remarks:
5 animals
Time point:
other: 1, 24, 48, 72 hours & 7 days
Score:
13.2
Max. score:
65
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 4/5 gave positive response at 24 hours
Irritation parameter:
cornea opacity score
Remarks:
Group 1 - eyes rinsed after 5 mins
Basis:
mean
Remarks:
5 animals
Time point:
other: 1, 24, 48, 72 hours & 7 days
Score:
0
Max. score:
20
Irritation parameter:
iris score
Remarks:
Group 1 - eyes rinsed after 5 mins
Basis:
mean
Remarks:
5 animals
Time point:
other: 1, 24, 48, 72 hours & 7 days
Score:
0
Max. score:
10
Irritation parameter:
conjunctivae score
Remarks:
(Redness) Group 1 - eyes rinsed after 5 mins
Basis:
mean
Remarks:
5 animals
Time point:
other: 1, 24, 48, 72 hours & 7 days
Score:
7.2
Max. score:
15
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Remarks:
Group 1 - eyes rinsed after 5 mins
Basis:
mean
Remarks:
5 animals
Time point:
other: 1, 24, 48, 72 hours & 7 days
Score:
5.8
Max. score:
20
Reversibility:
fully reversible within: 7 days
Irritation parameter:
overall irritation score
Remarks:
Group 2 - eyes rinsed after 24 hours
Basis:
mean
Remarks:
3 animals
Time point:
other: 1, 24, 48, 72 hours & 7 days
Score:
13.7
Max. score:
65
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 3/3 gave positive response at 24 hours
Irritation parameter:
cornea opacity score
Remarks:
Group 2 - eyes rinsed after 24 hours
Basis:
mean
Remarks:
3 animals
Time point:
other: 1, 24, 48, 72 hours & 7 days
Score:
0
Max. score:
20
Irritation parameter:
iris score
Remarks:
Group 2 - eyes rinsed after 24 hours
Basis:
mean
Remarks:
3 animals
Time point:
other: 1, 24, 48, 72 hours & 7 days
Score:
0
Max. score:
10
Irritation parameter:
conjunctivae score
Remarks:
(Redness) Group 2 - eyes rinsed after 24 hours
Basis:
mean
Remarks:
3 animals
Time point:
other: 1, 24, 48, 72 hours & 7 days
Score:
7
Max. score:
15
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Remarks:
Group 2 - eyes rinsed after 24 hours
Basis:
mean
Remarks:
3 animals
Time point:
other: 1, 24, 48, 72 hours & 7 days
Score:
6.7
Max. score:
20
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Group 1 Rabbits (eyes rinsed after 5 mins): Four out of five animals gave a positive response at the 24 hour observation. the reaction reduced and no positive reaction was apparent at 7 days.

Group 2 Rabbits (eyes rinsed after 24 hours): All three animals gave a positive response at the 24 hour observation. The reactions reduced and all eyes were clear at 7 days.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
In a US guideline study, instillation of tetraammine platinous chloride (0.1 g) to the right eye of eight rabbits for 5 min or 24 hr caused irritation which was fully reversible within 7 days.
Executive summary:

In a US guideline study, the eye irritant potential of tetraammine platinous chloride was assessed in eight female New Zealand white rabbits. A group of three rabbits received a 0.1 g instillation of the powdered test material to the right eye. After 24 hr the eyes were rinsed and the animals were observed for up to 7 days. Another group of five rabbits were subject to the same procedure though the eye was rinsed after 5 minutes.

Redness and swelling of the conjunctiva occurred within 1 hr of exposure in both groups, and was fully reversible within 7 days. No effects were evident in the iris or cornea within the observation period. No differences in the severity of the conjunctival effects were apparent for the two exposure times.

Based on the results of this study, the test material should be classified as an eye irritant (category 2) under EU CLP criteria (EC 1272/2008).