Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
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:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
According to "Appraisal of the safety of chemicals in foods, drugs and cosmetics" , by the staff of the Division of Pharmacology FDA, 1959
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Zucht Winkelmann (Paderborn)
- Fasting period before study: 16 hors before application
- Weight at study initiation: between 140 and 230 g
- Housing: group, 5 animals
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 45 - 55
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
10, 12.6, 15.9, 20.0 mL/kg ( 9.94, 12.14, 15.32, 19.28 g/kg)
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
12 900 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Original data: 13.41 mL/kg
Mortality:
10 mL/kg: 1 female
12.6 mL/kg: 3 male and 2 female, day 5
15.9 mL/kg: 1 male after 48 h, 3 female day 5, 1 female day 7, 1 female day 8
20.00 mL/kg: 1 male and 2 female after 24 h, 2 female after 48 h, 4 male and 1 females day 5
Clinical signs:
20 mL/kg: Apathy
all Doses: depression, piloerection, anomaly position, coordination disturbance, reduced grasp and extremities tone
Symptoms were seen 20 min after application up to 24 hours. Normal behaviour was seen from 24 hours onwards.
Gross pathology:
In animals that were found dead inflamed mucosa of stomach and intestinal mucosa was observed. All sacrificed animals did not show any gross internal lesions.

Any other information on results incl. tables

Mortality

Dose (mL/kg)

No. of animals

Died within

24 h

48 h

5 days

7 days

8 days

14 days

10

5 male

0/5

0/5

0/5

0/5

0/5

0/5

 

5 female

0/5

0/5

1/5

1/5

1/5

1/5

12.6

5 male

0/5

0/5

3/5

3/5

3/5

3/5

 

5 female

0/5

0/5

2/5

2/5

2/5

2/5

15.9

5 male

0/5

1/5

1/5

1/5

1/5

1/5

 

5 female

0/5

0/5

3/5

4/5

5/5

5/5

20.0

5 male

1/5

1/5

5/5

5/5

5/5

5/5

 

5 female

2/5

4/5

5/5

5/5

5/5

5/5

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met