Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1982-11-01 to 1983-01-07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
5000 mg/kg bw, instead of 2000 mg/kg bw, was administered as limit dose.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: males: 9 weeks, females: 14 weeks
- Weight at study initiation: males: 186 to 196 g, females: 165 to 174 g
- Fasting period before study: 16 hours before and 4 hours after treatment
- Housing: Animals were kept in Makrolon cages type III on dust-free wood granules
- Diet (e.g. ad libitum): Altromin R 1324 from Altromin GmbH, Lage, Germany; ad libitum
- Water (e.g. ad libitum): tap water; ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1.5
- Humidity (%): 60 ± 5
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
tap water
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 20 mL kg bw

DOSAGE PREPARATION: The test item was formulated in tap water at room temperature
Doses:
5000 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 observations: On the day of application animals were observed multiple times. During the 14 days observation period animals were observed twice daily (once at weekend and holidays). Type, onset, duration and intensity of clinical symptoms were examined
- Frequency of weighing: Animals were weighed on the day of application, after one week and after 14 days
- Necropsy of survivors performed: yes, on a random basis
Statistics:
not applicable

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No mortality observed
Clinical signs:
No effects observed
Body weight:
No effects observed
Gross pathology:
No effects observed

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an acute oral toxicity study in rats, no mortality has been observed at a dose of 5000 mg/kg bw. Hence, the LD50 value can be considered to be greater than 5000 mg/kg bw. The substance is not classifiable according to GHS criteria.
Executive summary:

In an acute oral toxicity study, groups of fasted young adult Wistar rats (5/sex) were given a single oral dose of the test item in water at a dose of 5000 mg/kg bw and observed for 14 days. All animals survived until the end of the study. No clinical signs and/or effects on body weight were observed. Gross pathology performed on certain animals revealed no adverse signs. Based on the results, the oral LD50 in both male and female rats can be considered to be greater than 5000 mg/kg bw.

Based on these results, no classification for acute oral toxicity is warranted according to CLP criteria.