Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
9 to 23 January 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Conducted according to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): tetrammine platinum (II) hydrogen carbonate
- Substance type: Technical product
- Physical state: solid (powder)
- Lot/batch No.: JF0177
- Storage condition of test material: Stored at < 25 degC, protected from light

Test animals

Species:
rat
Strain:
other: Sprague-Dawley CD (Crl : CD ® BR)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Limited
- Age at study initiation: 8-12 weeks old
- Weight at study initiation: males 209-236 g; females 206-227 g.
- Fasting period before study: none
- Housing: Housed individually during the 24-hr exposure period, then in groups of five by sex in suspended polypropylene cages on woodflakes
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-21
- Humidity (%): 41-55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: back and flanks
- % coverage: 10% of total body surface area
- Type of wrap if used: surgical gauze and self-adhesive bandage, secured with “Blenderm” latex- free, hypoallergenic, surgical tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with cotton wool moistened in distilled water
- Time after start of exposure: 24 hr

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- For solids, paste formed: yes, powder moistened with distilled water

VEHICLE
- Amount(s) applied (volume or weight with unit): not stated
Duration of exposure:
24 hr
Doses:
2000 mg/kg bw

No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed at 0.5, 1, 2 and 4 hrs after dosing, then daily for 14 days; weighed before treatment then weekly for 2 weeks.
- Necropsy of survivors performed: yes
- Other examinations performed: behavioural and clinical signs, body weight changes.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
None
Body weight:
Nine of the 10 rats showed normal gain in body weight. One female lost weight during the first week and then showed expected weight gain in second week.
Gross pathology:
No abnormalities
Other findings:
- Other observations: No dermal reactions, including erythema and oedema, were seen during the 14-day period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In rats, the acute dermal LD50 value (24-hour semi-occlusive application) for tetrammine platinum (II) hydrogen carbonate was >2000 mg/kg bw.
Executive summary:

An acute dermal toxicity test was conducted in the Sprague-Dawley CD strain rat, in accordance with OECD Test Guideline 402 and to GLP. Ten rats (five males and five females) were given a single 24-hour, semi-occluded dermal application of tetraammineplatinum hydrogen carbonate to intact skin at a dose level of 2000 mg/kg bw. The animals were observed for 14 days after the day of treatment and were then killed for gross pathological examination.

 

There were no deaths, and no signs of systemic toxicity or skin irritation during the study. All rats showed the expected increase in body weight during the study except for one female which showed body weight loss during the first week only. No abnormalities were noted at necropsy.

 

The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was >2000 mg/kg bw.

Based on the results of this study, tetraammineplatinum hydrogen carbonate does not require classification for acute dermal toxicity according to EU CLP criteria (EC 1272/2008).