Dicarbonyl(pentane-2,4-dionato-O,O')rhodium

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 January 1981 – 10 February 1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study apparently performed according to the method described by Noakes DN and Sanderson DM (1969) Br. J. ind. Med. Vol. 26, P. 59-64, which has some deviations from current OECD guidelines. Limited reporting, notably of test material (e.g. purity).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Noakes DN and Sanderson DM (1969) Br. J. ind. Med. Vol. 26, P. 59-64

Deviations:

not specified

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

The animals were prepared by closely clipping the hair “on the day of the test” (guideline states that this should be done approx. 24 hrs before the test), the animals weighed between 210 and 400 g (guideline suggests rats weighing 200-300 g be used) and

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dicarbonyl(pentane-2,4-dionato-O,O')rhodium

EC Number:

238-947-9

EC Name:

Dicarbonyl(pentane-2,4-dionato-O,O')rhodium

Cas Number:

14874-82-9

Molecular formula:

C7H7O4Rh

IUPAC Name:

Dicarbonyl(pentane-2,4-dionato-O,O')rhodium

Details on test material:

- Name of test material (as cited in study report): MS 371; acetylacetonatodicarbonyl rhodium (1)
- Physical state: solid
- purity: no data
- Lot/batch No.: 085108

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Tuck and Sons Ltd, Battlesbridge, Essex
- Weight at study initiation: 210-400 g
- Housing: individually during the exposure period and then in groups of up to 5 in solid floor polypropylene cages furnished with softwood sawdust
- Diet: ad libitum rat diet supplied by Nottingham University, Sutton Bonington, Near Loughborough, Leicestershire
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Air changes (per hr): a minimum of 20 air changes/hr
- Photoperiod (hrs dark / hrs light): lighting cycle of 12 hrs on and 12 hrs off with no daylight

Administration / exposure

Type of coverage:

occlusive

Vehicle:

arachis oil

Details on dermal exposure:

TEST SITE
- Area of exposure: approx. 6 x 12 cm
- Type of wrap if used: elastic adhesive bandage backed with aluminium foil

REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin and surrounding hair sponged thoroughly with detergent and warm water, rinsed and dried.
- Time after start of exposure: 24 hrs

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 g/kg bw
- Concentration (if solution): 200 mg/ml
- Constant volume or concentration used: yes
- For solids, paste formed: yes - suspension

VEHICLE
- Amount(s) applied (volume or weight with unit): 10 ml/kg bw

Duration of exposure:

24 hrs

Doses:

2 g/kg bw

No. of animals per sex per dose:

5 rats/sex

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: ½, 1 and 4 hrs following treatment, and then once daily for 14 days
- Necropsy of survivors performed: yes, one male and one female
- Other examinations performed: clinical signs

Statistics:

Acute dermal median lethal dose (LD50)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: No deaths reported.

Mortality:

There were no mortalities throughout the 14 day observation period.

Clinical signs:

other: All animals showed subdued activity at the ½ hr observation period. No such effects were seen after 1 hr and no other clinical effects were noted.

Gross pathology:

No abnormal macroscopic lesions were seen in one male and one female survivor at termination of the study. (OECD guidelines recommend all animals are necropsied.)

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In a limit test, the acute percutaneous median lethal dose (LD50) of acetylacetonatodicarbonyl rhodium (I) in the rat was found to be >2000 mg/kg bw.

Executive summary:

Acetylacetonatodicarbonyl rhodium (I) was tested for its acute dermal toxicity in rats, using a method analogous to OECD Test Guideline 402 (with some minor deviations). A group of 5 male and 5 female Sprague-Dawley rats were treated dermally (application to clipped skin under occlusion; skin was clipped on the day of the test whereas the guideline recommends that this should be done approximately 24-hr before the test) with the test item at 2 g/kg bw (in arachis oil). After 24 hours the patch was removed, the skin washed and rinsed, and the rats observed for 14 days. No deaths or signs of overt toxicity were seen in either sex and there were no abnormal macroscopic lesions in the single necropsied male and female (OECD guidelines recommend all animals are necropsied).

 

Based on the results of this study, acetylacetonatodicarbonyl rhodium (I) should not be classified for acute dermal toxicity according to EU CLP criteria (EU 1272/2008).