2-cyano-2-[2,3-dihydro-3-(tetrahydro-2,4,6-trioxo-5(2H)-pyrimidinylidene)-1H-isoindol-1-ylidene]-N-methylacetamide

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:

acceptable restrictions: occlusive treatment, 24 h exposure, incomplete documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

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 treatment)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

5,5'-(1H-isoindole-1,3(2H)-diylidene)dibarbituric acid

EC Number:

253-256-2

EC Name:

5,5'-(1H-isoindole-1,3(2H)-diylidene)dibarbituric acid

Cas Number:

36888-99-0

Molecular formula:

C16H9N5O6

IUPAC Name:

5,5'-(1H-isoindole-1,3(2H)-diylidene)dipyrimidine-2,4,6(1H,3H,5H)-trione

Test material form:

solid

Details on test material:

- Physical state: solid
- Analytical purity: no data

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
- Weight at study initiation: mean weight: males 151 g, females 129 g

ENVIRONMENTAL CONDITIONS: not reported

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal, p.c., 50 cm²
- % coverage: > 10 %

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.5 g/kg animal
- Concentration (if solution): 50 % aequous solution
- For solids, paste formed: yes

Duration of exposure:

24 h

Doses:

2.5 g/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 observations and weighing: No weighing was done. Observation was several times at the day of exposure and daily on working days.
- Necropsy of survivors performed: yes

Statistics:

None

Results and discussion

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:

0/10 animals died after the exposure

Clinical signs:

other: no abnormalities detected

Gross pathology:

9/10 no abnormalities detected
1/10 right peak pulmonary lobe with chronic Bronchopneumonia

Other findings:

- Other observations: after 24 h local orange substance residues

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

After the end of the observation period (14 days), no mortality was observed. Therefore, the LD50 was determined to be the limit dose of 2500 mg/kg bw in male and female rats.

Executive summary:

This acute dermal toxicity test was conducted similar to OECD test guideline 402 and was performed according to the recommendations by Noakes and Sanderson (1969). 2.5 g/kg of the test substance was applied in a 50 % aequous solution to the back on a 50 cm² test site. No weighing of the animals was done. Observations occurred several times at the day of exposure and daily on working days.

14 days after application, no mortality occured. The LD50 was set to be 2500 mg/kg bw. For 9 out of 10 animals, no abnormalities in gross pathology were detected. One animal had a right peak pulmonary lobe with chronic Bronchopneumonia.