Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 Aug - 13 Sep 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
24 Feb 1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
EEC directive 92/69/EEC (July 31, 1992)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Niedersächsisches Umweltministerium, Hannover, Germany
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Hsd/Cpb:WU
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Females nulliparous and non-pregnant: not specified
- Weight at study initiation: 230 - 252 g (males) and 155 - 171 g (females)
- Fasting period before study: 16 h before administration and 3 -4 h after administration
- Housing: up to 5 animals per cage per sex, in Makrolon type III cages on LIGNOCEL bedding
- Diet: pelleted rat diet (Ssniff R-Alleindiät, Ssniff Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: drinking water, ad libitum
- Acclimation period: 6 days (range-finding study), 7 days (main study, females), 14 days (main study, males)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2.11 mL/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Range-finding test: 2 females
Main study: 5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were examined 10 min, 1 h, 2 h, 6 h and 24 h after treatment and thereafter once daily up to Day 14. Body weights were recorded immediately before treatment (Day 0) and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Results and discussion

Preliminary study:
No mortility occured in the range-finding test.
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
1/5 males and 0/5 females died
Clinical signs:
slight diarrhea in 5/5 males 24 h after treatment, fully reversible on Day 3; slight squatting position and slight piloerection in 1/5 female 24 h after treatment, fully reversible within 48 h.
Body weight:
Decreased body weight in 5/5 males and 2/5 females on Day 7.
Gross pathology:
In the animal found dead, test substance related findings of extreme redness of the gastric mucous membrane was observed.
In surviving animals, an adhesion of the stomach to other organs was found, mainly to the spleen which was enlarged in most animals. Additionally, particles of probably separated and indurated tissue portions were observed in the stomach.

Any other information on results incl. tables

Table 1. Results of the acute oral toxicity study in rats.

Dose level

(mg/kg bw)

Mortalities

Clinical signs

males

2000

1/5

5/5

females

2000

0/5

1/5

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
In this acute oral toxicity study in male and female rats a LD50 value of > 2000 mg/kg bw was found.