Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Wistar
Remarks:
TNO/W74
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann (Borchen)
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 9 weeks
- Weight at study initiation: 150 - 200g
- Fasting period before study: 16h before up to 4h after application
- Housing: in groups of 5 in Makrolon type III cages
- Diet (e.g. ad libitum): Altromin (R) 1324 ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: several days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 50 +/- 10%
- Photoperiod (hrs dark / hrs light): 12h/12h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
administered at a constant application volume of 30 mL/kg bw
Doses:
1000, 2000, 2500, 3100, 3500 and 5000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: day of application: multiple observations; during 14 days observation: twice per working day, once on weekend and holiday; weekly weighing
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight
Statistics:
Probit analysis

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
2 570 mg/kg bw
Based on:
test mat.
95% CL:
> 2 260 - < 2 830
Mortality:
From 2000 mg/kg bw on, death occured on day 2 (in the highests doese group from day 1) with mortality rates from 10 to 100%.
Clinical signs:
In dose 2000 to 4000 mg/kg bw: nausea, diarrhoea, abdominal position, staggering gait and poor general condition.
Signs occured from 2 hours after application to 4 days after application.
Body weight:
Slightly affected in all dose groups

Any other information on results incl. tables

 

Dose [mg/kg bw]

1000

2000

2500

3100

3500

4000

Number of animals

dead

0

1

5

8

9

10

with symptoms

0

10

10

10

10

10

treated

10

10

10

10

10

10

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 (oral, gavage) for female wistar rats was determined to be 2570 mg/kg bw under the conditions of the test. The substance is not classifiable according to CLP criteria.