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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

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:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Iffa Credo
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 6 weeks
- Weight at study initiation: 177 +/- 3 g for males and 148 +/- 3 g for females
- Fasting period before study: 18 hours before treatment
- Housing: 4 or 7 animals/ sex during acclimatation and 5 animals/sex during study
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 50+/- 20 %
- Air changes (per hr): non recycle but filtered with absolute filters
- Photoperiod (hrs dark / hrs light): 12 hours

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Lot/batch no. (if required): 1279

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5/sex/dose. Some doses with only one sex.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations:
clinical signs: every hours after treatment then at least once a day until termination
mortality: at least twice a day
- Necropsy of survivors performed: yes
- Other examinations performed:
body weight: just before treatment and at Day 5, 8 and 15
organ weights: no
histopathology: no macroscopic findings was observed consequently, no histological exam was performed

Results and discussion

Preliminary study:
A prelimiminary study showed >50% of mortality at 2000 mg/kg bw, 4 doses has been established to assess LD50 in males: 500, 700, 980 and 1400 mg/kg bw for males and 2 doses in females: 700, 980 mg/kg bw
Effect levelsopen allclose all
Key result
Sex:
female
Dose descriptor:
approximate LD50
Effect level:
> 980 - < 2 000 mg/kg bw
Based on:
test mat.
Key result
Sex:
male
Dose descriptor:
approximate LD50
Effect level:
> 700 - < 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Mortality in males: 0% at 500 mg/kg bw; 0% at 700 mg/kg bw; 60% at 980 mg/kg bw; 60% at 1400 mg/kg bw and 40% at 2000 mg/kg bw
Mortality in females: 20% at 500 mg/kg bw; 20% at 980 mg/kg bw and 100% at 2000 mg/kg bw
Clinical signs:
The clinical signs observed were a decrease in spontaneous activity for a certain period (from 4 hours to 3 days) relating to the dose administered. Piloerection was recorded after 1 to 4 hours at 700 and 980 mg/kg bw or after 1 to 48 hours at 1400 mg/kg bw.
Dyspnea was noted after one hour in 1 animal at 1400 mg/kg bw.
A reddish vaginal discharge was seen after 24 hours in 2 females at 700 mg/kg bw.
Swelling of the face was observed after 4 and 6 hours in the males at 2000 mg/kg bw.
No clinical sign was observed after 6 hours at 500 mg /kg bw, afer 24 hours in the males at 700 mg/kg bw, after 48 hours in the males at 2000 mg/kg bw, after 72 hours in the surviving females at 700 mg/kg bw and the surviving animals at 980 and 1400 mg/kg bw.
Body weight:
The body weight gain of the animals was normal between D-1 and D-5 after administration of 500 and 700 mg/kg bw and had decreased slightly after administration of 980, 1400 and 200 mg/kg bw. The body weight gain was normal in all the surviving animales between D-5 and D-15
Gross pathology:
The macroscopic examination revealed no abnormalities in the animals found dead during the study or sacrificed at the end of the study

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Under test conditions, test item is classified Acute oral tox. cat.4, H302 (CLP regulation)
Executive summary:

According to a GLP study following TG OECD 401 (1987), 700 > LD50 < 2000 mg/kg bw,  a CLP classification Acute oral tox. cat.4, H302 is proposed