Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21 September 1989 - 18 December 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study, to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): Tetrakis(triphenylphosphine)palladium

- Physical state: yellow crystals

- Composition of test material, percentage of components: 9% Pd

- Lot/batch No.: Order 23819

- Stability under test conditions: Not indicated by sponsor
- Storage condition of test material: Closed container (under nitrogen) at room temperature

Test animals / tissue source

Species:
rabbit
Strain:
other: White Russian (albino)
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: ASTA Pharma AG, D-4800 Bielefeld 14
- Age at study initiation: 11 months
- Weight at study initiation: 2.67 - 2.97 kg
- Housing: Stainless steel cages with grating floor
- Diet (e.g. ad libitum): approx. 120 g/day standard diet
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23
- Humidity (%): 45 - 65

- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: To:

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other:
Amount / concentration applied:
0.06 g (approximately 0.1 ml volume)
Duration of treatment / exposure:
Test substance placed into conjunctival sac of right eye and the eye briefly held closed. Treated eye not rinsed
Observation period (in vivo):
1, 24, 48 and 72 hours post application, then daily until 6 days post application
Number of animals or in vitro replicates:
3 females
Details on study design:
Preliminary inspection of the eyes 24 hours prior to treatment; test substance placed into conjunctival sac of right eye and the eye briefly held closed; left eye remained untreated; treated eye not rinsed. Examined using Cliptrix pencil light.

Results and discussion

Results of in vivo studyopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 24, 48 & 72 hours
Score:
6
Max. score:
110
Reversibility:
fully reversible within: 4 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
80
Remarks on result:
other: Reversibility not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
10
Remarks on result:
other: Reversibility not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hours
Score:
5.7
Max. score:
20
Reversibility:
fully reversible within: 4 days
Irritant / corrosive response data:
Hyperaemia or diffuse crimson discolouration of the conjuctiva; slight or obvious swelling with partial eversion of the eyelids; slight discharge, or discharge with moistening of the surrounding eyelids and hair, or moistening of considerable parts around the eye.

No effects were seen in the untreated eye of each animal.
Other effects:
No systemic toxicity was recorded.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a guideline GLP study, a single application of 0.06 g tetrakis(triphenylphosphine) palladium into one eye of 3 white rabbits caused slight transient irritation (not sufficient for classification).
Executive summary:

The eye irritation potential of tetrakis(triphenylphosphine) palladium was determined in an OECD Test Guideline 405 study, conducted to GLP. The test substance (0.06 g, equivalent to 0.1 mL) was placed in the conjunctival sac of one eye, which was briefly held closed, in three female White Russian rabbits. The treated eye was not rinsed. The untreated eye in each case served as the control. The eyes were examined 1, 24, 48 and 72 hr following the application, then daily until 6 days post application.

 

No signs of irritation were observed on the cornea or iris. Hyperemia or crimson discolouration, slight or obvious swelling with partial eversion of lids was seen in the conjunctiva. There was also slight discharge or discharge with moistening of considerable parts around the eyes. The findings had completely disappeared at day 4 of observation. The primary irritation index was calculated as 6 (out of a possible 110).

 

Based on the results of this study, tetrakis(triphenylphosphine) palladium should not be classified for eye irritation according to EU CLP criteria (EC 1272/2008).