Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- product number: GPAD 185
- CAS number: 104-15-4
- appearance: grey to white, cristalline powder
- MW: 190.2 g/mol
- melting point: 98 °C
- decomposition temperature: approx. 170 °C
- solubility: readily in water
- pH in water: below 1
- imurities: 0.3% H2SO4
- purity: > 98 %
- storage: in the dark at room temperature under local exhaust ventilation

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF-Zucht
- Age at study initiation: 7 (males) or 8 (females) weeks
- Weight at study initiation: 197 +/- 3 g (males or 189 +/- 4 g (females)
- Housing: in groups (5 animals)
- Diet (e.g. ad libitum): Rattendiät Altromin 1324 (Altromin-GmbH, Lage/Lippe), ad libitum
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
- application volume: 10 mL/kg bw.
- concentration (w/v) at the 1250 mg/kg bw. dose level: 12,5 %
- concentration (w/v) at the 1600 mg/kg bw. dose level: 16,0 %
- concentration (w/v) at the 2000 mg/kg bw. dose level: 20,0 %
Doses:
1250; 1600; 2000 mg/kg bw
No. of animals per sex per dose:
- 1250 mg/kg Bw.: 5 females
- 1600 mg/kg bw.: 5 females
- 2000 mg/kg bw.: 5 males, 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 28 days
- Frequency of observations and weighing: once weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 1 410 mg/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
- 1250 mg/kg bw.: 2/5 females; males not tested
- 1600 mg(kg bw.: 3/5 females; males not tested
- 2000 mg/kg bw.: 4/5 females; 2/5 mals
Clinical signs:
Reduced spontaneous activity, squatting posture, irregular respiration, staggering, ataxia, high stepping gait, narrow eylids, piloerection, abdominal position, miosis, diarrhoe, hyperesthesia, poor general state.
Body weight:
Readuced body weight gain
Gross pathology:
- dark coloured liver
- reddened pancreas
- red to yellow fluid accumulation in the stomach
- reddened connective tissue
- white spotted storages in the fat tissue
- reddened gastro-intestinal tract
- black content (blood) in gastrintestinal tract
- red, clear liquid (blood) in gastriointestinal tract
- bleedings of the inner gastroinstestinal membrane
- gastric and intestinal mucosa partially white colored and detached
- glassy appearance of the intestine
- greatly enlarged stomage
- stomage, spleen and liver partially connected
- brightened adrenal glands
- dark red spotted lungs
- brightened spleen

Any other information on results incl. tables

Findings were observed untill day 28 after administration.

Applicant's summary and conclusion