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Administrative data

Description of key information

In a guideline study, to GLP, tetraammineplatinum(II) hydrogen carbonate did not cause skin sensitisation in a Buehler test in which guinea pigs were dermally challenged with 50% of the test compound following a 2-week induction period involving three 6-hr epicutaneous occlusive applications at the same concentration (Berthold, 1998).

 

In a guideline study, to GLP, tetraammineplatinum(II) hydrogen carbonate was non-sensitising to guinea pigs dermally challenged with a 75% concentration of the test compound following a two-stage induction with 25% by intradermal injection and 75% by topical application (Jones, 1989).

 

No respiratory tract sensitisation data are available.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11-Nov-1997 to 11-Dec-1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
OECD guideline study to GLP
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
Study conducted in 1998
Species:
guinea pig
Strain:
other: HsdPOC:DH
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan-Winkelmann GmbH, D-33176 Borchen

- Age at study initiation: 8 weeks

- Weight at study initiation: males 421-496 g, females 369-465 g

- Housing: Macrolon cages type IV, 1 per cage, biological bedding (Hugro® 560)

- Diet: Ssniff® Ms-Z complete diet for guinea pigs, ad libitum

- Water: drinking water quality, with vitamin C added twice weekly, time-switched drinking water system with drinking nipples

- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5-21.7

- Humidity (relative, %): 40-64

- Air changes (per hr): no data

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

Route:
epicutaneous, occlusive
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
Aqueous, 1%, trade name Tylose
Concentration / amount:
50%
Route:
epicutaneous, occlusive
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
Aqueous, 1%, trade name Tylose
Concentration / amount:
50%
No. of animals per dose:
Vehicle control group 1 (designated for 1st challenge): 10 (5 males, 5 females)
Vehicle control group 2 (designated for 2nd challenge): 10 (5 males, 5 females)
Test group: 20 (10 males, 10 females)
Details on study design:
RANGE FINDING TESTS: No irritation with test substance at 50% in a preliminary test

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 (days 1, 8 and 15)

- Exposure period: 15 days

- Test groups: 10 males and 10 females

- Control group: 5 males and 5 females in each of 2 vehicle control groups (one group each designated for challenge and re-challenge). Treated with vehicle only.

- Site: Left flank, 3 x 3 cm area shaved, 2 x 2 cm patch

- Frequency of applications: once per week

- Duration: 6 hours

- Concentrations: 50% (amount 0.5 g)

B. CHALLENGE EXPOSURE
- No. of exposures: 1

- Day(s) of challenge: day 29

- Exposure period: 6 hours

- Test groups: all 20 test animals were challenged (10 males and 10 females)

- Control group: half the vehicle control animals were challenged ( 5 males and 5 females) wity test substance, like test animals.

- Site: Test substance preparation applied to right flank, vehicle applied to left flank, 3 x 3 cm areas shaved, 2 x 2 cm patches

- Concentrations: 50% (0.5 g)

- Evaluation (hr after challenge): 24 and 48

OTHER:
- Re-challenge:
- Not done due to unequivocality of the results of the 1st challenge.

- Systemic toxicity:
- Behaviour and general appearance (during the study)
- Clinical symptoms (during the study)
- Body weights (start and end of study)
Positive control substance(s):
yes
Remarks:
No concurrent positive control, but alpha-hexylcinnamaldehyde was eval. for skin sensitisation potential in same strain of guinea pig in Feb/Mar 1997 (ASTA study number 914411). 3/10 animals reacted with erythema and 1/10 with oedema after 1st challenge
Positive control results:
At 1st challenge, erythema in 3/10, oedema in 1/10
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50% (0.5 g)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No adverse effects
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% (0.5 g). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No adverse effects.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50% (0.5 g)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No adverse effects
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50% (0.5 g). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No adverse effects.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50% (0.5 g)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No adverse effects
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50% (0.5 g). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No adverse effects.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50% (0.5 g)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No adverse effects
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50% (0.5 g). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No adverse effects.
Interpretation of results:
GHS criteria not met
Conclusions:
In a guideline study, to GLP, tetraammineplatinum(II) hydrogen carbonate did not cause skin sensitisation in a Buehler test in which guinea pigs were dermally challenged with 50% of the test compound (in 1% aqueous CMC) following a 2-week induction period involving three 6-hr epicutaneous occlusive applications of an identical concentration of the test item.
Executive summary:

The skin sensitisation potential of tetraammineplatinum(II) hydrogen carbonate was evaluated using a Buehler test in guinea pigs, conducted in accordance with OECD Test Guideline 406 and to GLP. Animals (10/sex) received three 6 -hr epictuaneous applications of the test material at 50% in 1% aqueous carboxymethyl cellulose (CMC) during a 2-week induction period .There were no skin responses to an epicutaneous occlusive challenge exposure to an identical concentration (50% in 1% aqueous CMC) 2 weeks later.

Based on the results of this study, no classification for skin sensitisation is required according to EU CLP criteria (EC 1272/2008).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

No relevant human skin sensitisation data were identified. No in vitro skin sensitisation studies were identified, or are required, as a reliable in vivo study is already available.

 

The skin sensitisation potential of tetraammineplatinum(II) hydrogen carbonate was evaluated using a Buehler test in guinea pigs, in accordance with OECD Test Guideline 406. Animals (10/sex) received three 6 -hr epicutaneous applications of the test material at 50% in 1% aqueous carboxymethyl cellulose (CMC) during a 2-week induction period .There were no skin responses to an epicutaneous occlusive challenge exposure to an identical concentration (50% in 1% aqueous CMC) 2 weeks later (Berthold, 1998).

 

The skin sensitisation potential of tetraammineplatinum(II) hydrogen carbonate was assessed in an OECD Test Guideline 406 guinea pig maximisation test (GPMT), to GLP, using groups of 20 test and 10 control animals. Guinea pigs were induced with a suspension of 25% test material in arachis oil by intradermal injection (in combination with a preparation of Freund’s complete adjuvant), followed one week later by a second induction by topical application of 75% of the test substance in arachis oil under a 48-hr occlusive patch. Control animals were similarly treated but without the test substance. Two weeks after the topical inductions, a challenge dose of 75% was applied under a 24-hr occlusive patch to both test and control animals. These doses were selected after a preliminary range-finding study. No positive reactions were observed in the test or control animals on examination at 24 and 48 hr after removal of the challenge patches. Tetraammineplatinum(II) hydrogen carbonate was not a contact sensitiser in this GPMT (Jones, 1989).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

No respiratory tract sensitisation data are available. A new study was not conducted as no standard and validated test method is available and it is not a REACH Standard Information Requirement.

Justification for classification or non-classification

Based on the lack of skin sensitisation apparent in studies with tetraammineplatinum(II) hydrogen carbonate (Buehler test and GPMT), classification for skin sensitisation is not required according to EU CLP criteria (EC 1272/2008).