Trisodium bis[4-[4,5-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-3-methyl-5-oxo-1H-pyrazol-1-yl]benzene-1-sulphonato(3-)]ferrate(3-)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May I974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

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)

Deviations:

not specified

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Acid Brown 098

IUPAC Name:

Acid Brown 098

Test animals

Species:

rat

Strain:

other: CFY

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 244 - 280 g

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- % coverage: 10 % of the total body surface
- Type of wrap if used: The treated area was then promptly covered with aluminium foil which was held in place with "Sleek" waterproof plaster encircled firmly round the trunk .

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): dosage volume of 6.7ml/kg bodyweight
- Concentration (if solution): 75% aqueous suspension

Duration of exposure:

24 hours

Doses:

0, 5000 mg/kg

No. of animals per sex per dose:

5 male rats

Control animals:

yes

Remarks:

Negative control

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: 1, 7 and 14 days
- Necropsy of survivors performed: yes, all rats were sacrificed and examined macroscopically in an attempt to identify any target organs.

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male

Dose descriptor:

LD0

Effect level:

ca. 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality observed

Clinical signs:

Signs of reaction to treatment consisted of slight lethargy only. No signs of irritation to the skin were observed during the two week observation period.

Gross pathology:

Normal autopsy findings.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified according to the CLP Regulation (EC n. 1272/2008)

Remarks:

Migrated information According to the CLP Regulation (EC n. 1272/2008) Criteria used for interpretation of results: EU

Conclusions:

LD0 = 5000 mg/kg bw
LD50 > 5000 mg/kg bw

Executive summary:

The substance has been tested for acute toxicity by dermal route according to a method similar to the one described in the OECD Guideline 402. Ten male rats are tested at the limit concentration of 5000 mg/kg b.w. Signs of reaction to treatment consisted of slight lethargy only. No signs of irritation to the skin were observed during the two week observation period.

Results

The acute median lethal percutaneous dose (LD50) to male rats was found to be greater than 5000 mg/ kg bodyweight. The substance is not classified according to the CLP Regulation (EC n. 1272/2008).