Reaction mass of sodium sulphate and trisodium trioxalatoferrate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Remarks:

Early study, but reporting the main relevant details, No GLP, short report

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Remarks:

pre-dates GLP

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of sodium sulphate and trisodium trioxalatoferrate

EC Number:

947-037-7

IUPAC Name:

Reaction mass of sodium sulphate and trisodium trioxalatoferrate

Test animals

Species:

rat

Strain:

other: CFY strain

Sex:

male

Details on test animals or test system and environmental conditions:

no data

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: dorso-lumbar region
- Type of wrap if used: Al foil + waterproof plaster

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm (40-50°C} dilute soap solution
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume): 6,7 mL/kg
- Concentration: 75 % suspension
- Constant volume or concentration used: yes
- For solids, paste formed: yes

Duration of exposure:

24 h

Doses:

5 000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

yes, concurrent vehicle

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD0

Effect level:

>= 5 000 mg/kg bw

Mortality:

None

Clinical signs:

other: shortly after dosing slight lethargy. One rat showed slight erythema on the fourth day of treatment only. This rat and another were observed to have small, raised, brown nodules on areas on the treated sites on the day after treatment only

Gross pathology:

Autopsy findings were normal

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute median lethal percutaneous dose (LD 50 ) to male rats of the test item was found to be: greater than 5000 mg/kg bodyweight.

Executive summary:

Ten male rats were treated with The test item at a dosage level of 5 g/kg bodyweight.

There were no mortalities. Signs of reaction to treatment, observed shortly after dosing, consisted of slight lethargy only, which persisted for three days. One rat showed slight erythema on the fourth day of treatment only. This rat and another were observed to have small, raised, brown nodules on areas on the treated sites on the day after treatment only. Bodyweight increases were normal compared with the controls. Autopsy findings were normal.

CONCLUSION: The acute median lethal percutaneous dose (LD 50 ) to male rats of gold 4 N was found to be: greater than 5000 mg/kg bodyweight.