Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19. March - 2. May 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
only females tested
GLP compliance:
no
Remarks:
performed before GLP implementation
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG
- Females (if applicable) nulliparous and non-pregnant: yes
- Weight at study initiation: 160-184 g
- Fasting period before study: yes, 16 h
- Housing: in groups in plastic cages, softwood pellets
- Diet (e.g. ad libitum): Altromin 1324 (Altromin GmbH, Lage/Lippe), ad libitum
- Water (e.g. ad libitum): Tap water ad libitum

IN-LIFE DATES: From: 19.3. To: 2.5.1979

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 25% test substance in 2% starch suspension
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25%
- Amount of vehicle (if gavage): 0.6 - 3.6 mL per animal


Doses:
1000, 3000 and 5000 mg/kg bw
No. of animals per sex per dose:
10 females/group
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observation for mortality/clinical signs, weekly weighing
- Necropsy of survivors performed: yes
Statistics:
LD50 calculation by Probitanalysis according to Linder and Weber

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
2 800 mg/kg bw
Based on:
act. ingr.
95% CL:
1 520 - 3 670
Mortality:
1000 mg/kg bw: 0/10
3000 mg/kg bw: 6/10
5000 mg/kg bw: 9/10
Clinical signs:
hunchd posture, increased breathing rate, tremor; all symptoms were reversible within 24 h
Body weight:
no effects observed
Gross pathology:
Survivors: no changes
Descedents: darkly reddened/spotted lungs and liver

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The median lethal dose of the testsubstance was 2800 mg per kg body weight. Based on the result of this study the test substance is acutely oral toxic, Cat 5.
Executive summary:

The test item was tested for its acute oral toxicity potential. 10 female rats were treated with doses of 1000, 3000, or 5000 mg/kg bw and observed for 14 days. The median lethal dose was 2800 mg per kg body weight. Based on the result of this study the test substance is acutely oral toxic, Cat 5 according to GHS criteria.