Registration Dossier
Registration Dossier
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EC number: 425-270-0 | CAS number: 134620-00-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15-16 March 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Guideline study, to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Tetramminepalladium (II) hydrogen carbonate
- IUPAC Name:
- Tetramminepalladium (II) hydrogen carbonate
- Reference substance name:
- 134620-00-1
- Cas Number:
- 134620-00-1
- IUPAC Name:
- 134620-00-1
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Tetrammine palladium hydrogen carbonate
- Substance type: No data
- Physical state: pale yellow powder
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No.: DD0274
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: room temperature
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Motson, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.60 kg
- Housing: Individually housed in a suspended metal cage
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-19 deg C
- Humidity (%): 49-50%
- Air changes (per hr): 15/hour
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 15 March 1995 To: 16 March 1995
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye acted as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (equivalent to 91 mg)
- Concentration (if solution): Not applicable
VEHICLE
- Amount(s) applied (volume or weight with unit): Not applicable
- Concentration (if solution): Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 24 hours [animal was killed for humane reasons after 24 hours due to signs of pain and discomfort]
- Number of animals or in vitro replicates:
- One
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not done
- Time after start of exposure: Not applicable
SCORING SYSTEM: Modified Kay and Calandra classification system
TOOL USED TO ASSESS SCORE: No data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Remarks:
- single animal tested
- Time point:
- other: 1 hour
- Score:
- 53
- Max. score:
- 110
- Reversibility:
- other:
- Remarks on result:
- other: animal killed at 24 hr for humane reasons
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Remarks:
- single animal tested
- Time point:
- 24 h
- Score:
- 81
- Max. score:
- 110
- Reversibility:
- other:
- Remarks on result:
- other: animal killed at 24 hr for humane reasons
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- single animal tested
- Time point:
- other: 1 hour
- Score:
- 40
- Max. score:
- 80
- Reversibility:
- other:
- Remarks on result:
- other: animal killed at 24 hr for humane reasons
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- single animal tested
- Time point:
- 24 h
- Score:
- 60
- Max. score:
- 80
- Reversibility:
- other:
- Remarks on result:
- other: animal killed at 24 hr for humane reasons
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- single animal tested
- Time point:
- other: 1 hour
- Score:
- 5
- Max. score:
- 10
- Reversibility:
- other:
- Remarks on result:
- other: animal killed at 24 hr for humane reasons
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- single animal tested
- Time point:
- 24 h
- Score:
- 5
- Max. score:
- 10
- Reversibility:
- other:
- Remarks on result:
- other: animal killed at 24 hr for humane reasons
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- single animal tested
- Time point:
- other: 1 hour
- Score:
- 8
- Max. score:
- 20
- Reversibility:
- other:
- Remarks on result:
- other: animal killed at 24 hr for humane reasons
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- single animal tested
- Time point:
- 24 h
- Score:
- 16
- Max. score:
- 20
- Reversibility:
- other:
- Remarks on result:
- other: animal killed at 24 hr for humane reasons
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- single animal tested
- Time point:
- other: 1 h
- Score:
- 2
- Reversibility:
- other:
- Remarks on result:
- other: animal killed at 24 hr for humane reasons
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- single animal tested
- Time point:
- 24 h
- Score:
- 3
- Reversibility:
- other:
- Remarks on result:
- other: animal killed at 24 hr for humane reasons
- Irritant / corrosive response data:
- Translucent corneal opacity was noted at the 1-hour observation with opalescent corneal opacity at the 24-hour observation.
Iridial inflammation was noted at the 1 and 24-hour observations.
Moderate conjunctival irritation was noted at the 1-hour observation with severe conjunctival irritation at the 24-hour observation.
The nictitating and conjunctival membranes were pale in appearance with petechial haemorrhage of the nictitating membrane at the 1 and 24-hour observations.
Due to signs of pain and discomfort the animal was killed after 24-hour observation for humane reasons. - Other effects:
- Residual test material was noted in the treated eye 1 and 24 hours after treatment.
Any other information on results incl. tables
| Irritation Parameter | Time after treatment |
|
| 1 hour | 24 hours | |
| Cornea | ||
| Degree of opacity | 2 | 3 |
| Area of opacity | 4 | 4 |
| Score | 40 | 60 |
| Iris | 1 | 1 |
| Score | 5 | 5 |
| Conjunctivae | ||
| Redness | 2 | 2 |
| Chemosis | 2 | 3 |
| Discharge | 0 | 3 |
| Score | 8 | 16 |
| Total score | 53 | 81 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- In a guideline study, to GLP, undiluted tetraamminepalladium(II) hydrogen carbonate (0.1 mL; 91 mg) produced very severe eye irritation following instillation into the eye of one rabbit. The animal was killed at 24 hours for humane reasons.
- Executive summary:
In an OECD guideline study (TG 405), conducted according to GLP, undiluted tetraamminepalladium(II) hydrogen carbonate (0.1 mL; 91 mg), was instilled into one eye of a single New Zealand white rabbit. The other eye remained untreated and acted as the control.
The treated eye was assessed, after 1 and 24 hours, using a modified Kay and Calandra classification system for signs of irritation on the cornea, iris and conjunctiva.
Tetraamminepalladium(II) hydrogen carbonate produced a maximum group mean score of 81.0 [maximum total score possible = 110] at 24 hours. The animal was killed at 24 hours for humane reasons and no further animals were tested.
The substance was, therefore, considered a very severe irritant in this test system. As the results were based on only one rabbit, it is not possible to give a definitive interpretation according to EU CLP criteria (EC 1272/2008). However, it is considered appropriate to classify the test material for serious eye damage (Category 1), as the severe effects observed are not expected to be reversible.
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