Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 March 1986 – 1 April 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted according to OECD guideline No. 402 and to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

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

Test material

Constituent 1
Reference substance name:
Rhodium(3+) acetate
EC Number:
247-460-0
EC Name:
Rhodium(3+) acetate
Cas Number:
42204-14-8
Molecular formula:
C6H9O6Rh
IUPAC Name:
Rhodium(3+);triacetate
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): rhodium (III) acetat “braun”
- Substance type: brown crystals
- Physical state: solid
- Composition of test material, percentage of components: 39.54% Rhodium
- Lot/batch No.: 6091
- Stability under test conditions: stable throughout the test period
- Storage condition of test material: at room temperature
- Other: soluble in water

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Savo Ivanovas med., Versuchstierzuchten GmbH, D-7940 Kisslegg in Allgäu
- Age at study initiation: males 3-4 months, females 3 months
- Weight at study initiation: males 2.5-2.65 kg, females 2.25-2.5 kg
- Fasting period before study: food withdrawn on day of treatment
- Housing: individually in wire-bottomed cages
- Diet: ad libitum standard diet, ssniff K “special diet for rabbits” supplied by ssniff Spezialfutter GmbH, D-4770 Soest
- Water: ad libitum
- Acclimation period: at least 5 days before application of test material

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.5-23.5
- Humidity (%): 45-60
- Photoperiod (hrs dark / hrs light): 6 am-6 pm fluorescent tube lighting, 6 pm-6 am “natural light-dark-rhythm”

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: between the shoulder and the hind leg region
- % coverage: no data
- Type of wrap if used: no data

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hrs

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: yes
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): used to dampen the test material
Duration of exposure:
24 hrs
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 21 days
- Frequency of observations and weighing: observed 6-8 hours after dosing then twice daily for 21 days or daily on Saturdays, Sundays and public holidays; body weight measured once/week
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No deaths
Clinical signs:
other: No signs of clinical toxicity seen in either the male or female rabbits.
Gross pathology:
No findings.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal median lethal dose (LD50) of rhodium (III) acetate “brown” was found to be >2000 mg/kg bw in rabbits.
Executive summary:

In an OECD Test Guideline 402 study, conducted according to GLP, the acute dermal toxicity of rhodium (III) acetate “brown” was investigated in New Zealand rabbits received. Animals (3/sex) received a single occlusive skin application of the test item (in water) at a limit dose of 2 g/kg bw. After 24 hours, the dressing was removed and the skin washed. The animals were observed twice daily and any deaths were recorded.

 

No mortality was observed at the limit dose, following the 21-day observation period. Slight transient weight loss was apparent in a single female. The dermal LD50 value was determined to exceed 2000 mg/kg bw.

 

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