Registration Dossier

Administrative data

Description of key information

There was no evidence of irritation when tetrakis(triphenylphosphine) palladium was applied to the intact skin of three rabbits using a 4-hour occluded patch (Zechel, 1989a).
An in vivo eye irritation test using three rabbits resulted in only transient mild irritation, not sufficient to meet the criteria for classification as an eye irritant (Zechel, 1989b).
No relevant respiratory tract data were identified.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
7 September 1989 - 18 December 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study, to GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
other: White Russian (albino)
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: ASTA Pharma AG, D-4800 Bielefeld 14
- Age at study initiation: 11 months
- Weight at study initiation: 2.68 - 2.75 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: I day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23
- Humidity (%): 45 - 65
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: To:
Type of coverage:
occlusive
Preparation of test site:
other: clipped free of hair 1 day before treatment
Vehicle:
water
Remarks:
Test substance moistened
Controls:
other: control site opposite was treated in the same way but without test substance
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g moistened with 0.43 ml water
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours after the end of treatment
Number of animals:
3
Details on study design:
Application sites on the dorsal skin were clipped free of hair 1 day prior to treatment; after application of the test substance, the test site was completely occluded; a control site opposite was treated in the same way but without test substance; at the end of the exposure, the skin was gently washed; observations of the treated skin were made 1, 24, 48 and 72 hours after the end of treatment; animals were observed for signs of systemic toxicity for 3 days post-application; irritation index calculated from the sum of the arithmetic means for erythma and oedema for the 4 time points; a descriptive grade was allocated according to the score
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Remarks on result:
other: Reversibility not applicable
Irritant / corrosive response data:
No erythema and no oedema were seen on the skin of any rabbit at any timepoint; treated skin was discoloured yellow due to the colour of the test substance
Other effects:
Systemic toxic effects did not occur after dermal application of the test substance. The general condition of the test animals was not affected.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a guideline GLP study, no irritation was observed following a single 4-hr occluded application of tetrakis(triphenylphosphine) palladium to the intact skin of three rabbits.
Executive summary:

The skin irritant potential of tetrakis(triphenylphosphine) palladium was assessed in a study conducted according to OECD Test Guideline 404 and to GLP.

 

No irritation was observed when 0.5 g of the test substance, moistened with water, was applied as a 4 hour occluded patch to the intact skin of three female White Russian (albino) rabbits, and observed at 1, 24, 48 and 72 hours following removal of the patch. The primary dermal irritation index was 0.

 

No skin classification, according to EU CLP criteria (EC 1272/2008), is required on the basis of this study.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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
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
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:
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.
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.
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).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No relevant irritation/corrosion human data were identified.

 

There is no indication that tetrakis(triphenylphosphine) palladium is likely to cause significant irritation to the skin or eyes. When applied to the intact skin of three rabbits using a 4-hour occluded patch, no irritation was seen. Animals were observed 1, 24, 48 and 72 hours following removal of the patch (Zechel, 1989a).

 

In an in vivo eye irritation test, tetrakis(triphenylphosphine) palladium was placed into one eye of each of three rabbits, with examination at 1, 24, 48 and 72 hours, and daily until 6 days, following application. No signs of irritation were seen in the cornea or iris. Slight irritation in the conjunctiva had completely disappeared by day 4 of observation (Zechel, 1989b).

 

No respiratory tract data were identified. A new study was not conducted as it is not a REACH Standard Information Requirement.


Justification for selection of skin irritation / corrosion endpoint:
OECD guideline study, and the only skin irritation study available.

Justification for selection of eye irritation endpoint:
OECD guideline study, and the only eye irritation study available.

Justification for classification or non-classification

Available in vivo assays gave results that failed to meet the criteria for classification for skin or eye irritation according to EU CLP criteria (EC 1272/2008).