Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study reliable without restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted 1987-02-24
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Sicocer F Eisenrosa 2320
- Physical state: powder, pink
- Storage condition of test material: room temperature
- Other: the sample appeared to be homogeneous

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS - Wistar (CHBB:Thom, (SPF))
- Age at study initiation: young adult animals
- Weight at study initiation: males: 175 - 183 g; females: 185 - 192 g
- Fasting period before study: the animals were given no feed at least 16 hours before administration, but water was available ad libitum
- Housing: single housing; stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, FRG); no bedding in the cages; sawdust in the waste trays
- Diet (ad libitum, except for fasting period as stated above): Kliba-Labordiaet 343, Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland
- Water (ad libitum): tap water
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS - the animals were housed in fully air-conditioned rooms.
- Temperature: range of 20 - 24 °C
- Relative humidity: range of 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Based on the physical and chemical characteristics of the test substance no pronounced acute oral toxicity was expected. Therefore a dose of 2200 mg/kg body weight had been chosen for the study.

VEHICLE
- Justification for choice of vehicle: aqueous formulation corresponds to the physiological medium.

MAXIMUM DOSE VOLUME APPLIED: 10.00 mL/kg

DOSAGE PREPARATION: test substance formulation with aqua bidest. (form of administration: suspension); time of day of administration was in the morning
Doses:
2200 mg/kg (concentration 22.000 g/100 mL)
No. of animals per sex per dose:
5 males / 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: individual body weights were determined shortly before application (day 0), weekly thereafter and at the end of the study (before fasting period). Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals. A check was made twice each workday and once on saturdays, sundays and on public holidays for general observations and for any dead or moribund animals.
- Necropsy of survivors performed: yes; necropsy at the last day of the observation period. Withdrawal of food at least 16 hours before killing with CO2; then necropsy with gross pathology examination. Necropsy of all animals that died before as early as possible.
Statistics:
not applicable

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 200 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 1% significance level
Mortality:
No mortality occurred.
Clinical signs:
Signs of toxicity have not been noted.
Body weight:
The expected body weight gain has been observed in the course of the study.
Gross pathology:
No abnormalities were noted at necropsy of animals sacrificed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 (male and female rats) > 2200 mg/kg bw
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not classified as acute toxic via the oral route.

According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as acute toxic via the oral route.