3,4,5,6-tetrachloro-N-[2-(4,5,6,7-tetrachloro-2,3-dihydro-1,3-dioxo-1H-inden-2-yl)-8-quinolyl]phthalimide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

incomplete documentation; occlusive treatment; 24 h exposure

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

occlusive treatment; 24 h exposure

GLP compliance:

no

Remarks:

performed prior to the implementation of GLP

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,4,5,6-tetrachloro-N-[2-(4,5,6,7-tetrachloro-2,3-dihydro-1,3-dioxo-1H-inden-2-yl)-8-quinolyl]phthalimide

EC Number:

250-063-5

EC Name:

3,4,5,6-tetrachloro-N-[2-(4,5,6,7-tetrachloro-2,3-dihydro-1,3-dioxo-1H-inden-2-yl)-8-quinolyl]phthalimide

Cas Number:

30125-47-4

Molecular formula:

C26H6Cl8N2O4

IUPAC Name:

4,5,6,7-tetrachloro-2-[2-(4,5,6,7-tetrachloro-1,3-dioxo-2,3-dihydro-1H-inden-2-yl)quinolin-8-yl]-1H-isoindole-1,3(2H)-dione

Test material form:

solid: nanoform

Details on test material:

- Physical state/ appearance: solid / yellow
- Shape of particles: spherical
- Aspect ratio: 1.5
- Particle size distribution: 62.7 nm
- Crystal structure: crystalline
- Surface area of particles: 29.6 m^2/g
- Surface treatment: no

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Wiga, Ottobrunn, Germany
- Mean weight at study initiation: males 136 g, females 119 g

ENVIRONMENTAL CONDITIONS: Not reported

Administration / exposure

Type of coverage:

occlusive

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

0.5% solution in water

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal, p.c., 50 cm²
- % coverage: considered to be > 10 % (mean bw of 136 g, calculated with the formula " surface area = 9.1 x bw (exp) 0.67"
- Type of wrap if used: no data
- Site of exposure: dorsal

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water containing mild detergent
- Time after start of exposure: no data

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.5 g/kg bw (5mL/kg bw)
- Concentration (if solution): 50 % suspension solution (in water 0.5% CMC)
- For solids, paste formed: yes

Duration of exposure:

24 h

Doses:

2500 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of weighing: before application
- Frequency of observations: daily (on working days: day 1, 2, 5, 6, 7, 8, 9, 12, 13 and 14)
- Necropsy of survivors performed: yes

Statistics:

not performed

Results and discussion

Preliminary study:

no data

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality and no clinical signs were observed.

Mortality:

No mortality ocurred.

Clinical signs:

other: No clinical signs were observed.

Gross pathology:

No abnormalities were observed.

Other findings:

After 24 h and 8 days: local yellow substance residues

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met