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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From July 20 to August 04, 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan-Winkelmann GmbH, Borchen.
- Females nulliparous and non-pregnant: yes.
- Age at study initiation: 8 weeks for male, 9 - 10 weeks for female.
- Weight at study initiation: average 199 g for male and average 173 g for female.
- Housing: conventional Makrolon cages, type III
- Fasting period before study: ca 16 hours before and 4 hours after dosing.
- Diet: standard diet "fixed-formula" Altromin 1324 Pellets, ad libitum.
- Water: libitum.
- Acclimation period: 5 days adaptation.

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 5 %
- Photoperiod: 12 hrs dark / 12 hrs light.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
- Volume of administration: 10 mg/kg bw
- Preparation: test substance was formulated in the application medium immediately before the treatment.
- Administration: first animals of a gender (male) were treated with the intended dose. As soon as it could be seen that the dose did not result in a high lethality, the female animals were treated to determine any gender differences.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 animals per sex
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: on the day of application (day 1), animals were examined several times daily; once on weekends and public holidays in the following 14-day observation period, recording the type, beginning, duration and intensity of the clinical symptoms as well as possible dead animals away.
- Frequency of weighing: immediately before application (day 1), after one week and at the end of the 14-day observation period the animals were individually weighed. The individual application volume was calculated by means of the body weight obtained immediately before the application.
- Necropsy of survivors performed: yes.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
No poisoning phenomena were observed during the 14-day observation time. Eight hours up to a day after the administration of test substance, blue discolouration of faeces was seen.
Body weight:
The growth was not influenced in male and female rats.
Gross pathology:
No abnormalities were observed.

Applicant's summary and conclusion

Interpretation of results:
other: not classified, according to the CLP Regulation (EC) No 1272/2008
Conclusions:
LD50 (male and female) > 2000 mg/kg bw
Executive summary:

Oral acute toxicity potential of test material was tested in rats, following procedures outlined in OECD guideline 401. A single dose of 2000 mg/kg bw was administered by gavage. Animales were observed for 14 days after dosing.

No death occurred during the main test and no poisoning phenomena were observed during the 14-day observation time. Eight hours up to a day after administration of test substance, blue discolouration of faeces was reported. No abnormalities were revealed by necropsy.

Conclusion

LD50 (male and female) > 2000 mg/kg bw