Zinc 5-nitroisophthalate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

not specified

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:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987-02-24

Deviations:

yes

Remarks:

body weight was not recorded during the observation period

GLP compliance:

no

Remarks:

not mandatory at the time of study conduct

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

liquid - solid: mixture of

Details on test material:

46.4% aqueous suspension of zinc 5-nitroisophthalate

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: WIGA, Sulzfeld
- Weight (mean): males: 235 g; females: 175 g
- Fasting period before study: ca. 16 hours before administration
- Diet (ad libitum): Altromin R 1324 (ALTROMIN GmbH, LAge/Lippe)
- Water (ad libitum)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- 0.5 aqueous solution of carboxymethyl cellulose

DOSAGE PREPARATION:
The product was prepared as a 46.4 % suspension in the vehicle.

Doses:

10000 mg/kg bw

No. of animals per sex per dose:

10 males / 10 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Examinations performed:
clinical signs
mortality: 1, 24 und 48 house as well as 7 and 14 days after adminsitration
- Necropsy of survivors performed: yes

Statistics:

not applicable

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

4 640 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Calculated LD50 for Sicorin RZ = 4640 mg/kg bw

Mortality:

No mortality occurred.

Clinical signs:

No symptom of poisoning was observed.

Body weight:

not specified

Gross pathology:

No findings were made during the autopsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 (rats, combined sexes) > 10000 mg/kg bw (calculated for Sicorin RZ = 4640 mg/kg bw)
According to the Regulation (EC) No 1272/2008 and subsequent adaptations, the substance is not acutely toxic via the oral route.