Registration Dossier

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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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 levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
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.