Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
09.11.2017 - 20.02.2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: approx. 8 weeks at start of administration
- Weight at study initiation: first step 177.0 ± 6.1 g (dose group 2000 mg/kg) and second step 183.3 ± 11.4 g (dose group 2000 mg/kg) at day of application
- Fasting period before study: 16 hours
- Housing: Three rats were housed in one Makrolon cage type III plus
- Diet (e.g. ad libitum): Commercial diet, ssniff® R/M-H V1534 served as food
- Water (e.g. ad libitum): ad libitum, drinking water in bottles
- Acclimation period: at least 5 adaptation days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 55% ± 15% (maximum range)
- Air changes (per hr): 12 to 18-fold air change per hour
- Photoperiod (hrs dark / hrs light): The rooms were lit (about 150 lux at approx. 1.50 m room height) and darkened for periods of 12 hours each.

IN-LIFE DATES: From: 13.11.2017 To: 18.01.2018

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000 mg/kg bw (two steps)
No. of animals per sex per dose:
6 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation: Observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after administration. All animals were observed for a period of 14 days; weighing: before dosing , after 7 days and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathological changes, no histopathology was carried out as no macroscopical findings were noted at autopsy.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Mortality:
2000 mg/kg bw - in the first and second step no animal died
Clinical signs:
2000 mg/kg bw: no symptoms of toxicity
Body weight:
2000 mg/kg bw - normal weight gain in all animals
Gross pathology:
The necropsy 14 days after oral application showed no test substance related macroscopic visible pathologic organ findings in the survived animals.
No pathological changes were observed at necropsy.

Applicant's summary and conclusion

Conclusions:
The LD50-value for acute oral toxicity of the test substance neodecanoic acid tin (2+)salt (2:1) is > 2000 mg/kg body weight.
Executive summary:

In an acute oral toxicity study performed according to the OECD Guideline 423, (Acute Toxic Class Method, 2001), 6 female 8 weeks old Crl: CD(SD) rats per group were given a single oral dose of test substance neodecanoic acid tin (2+)salt (2:1) at a dose of 2000 mg/kg bw and observed for 14 days.The test substance was applied undiluted.

 

The test substance was tolerated by the test animals at a dose of 2000 mg/kg body weight without any symptoms of toxicity. All animals gained the expected body weight at the end of the study period. No pathological changes were observed at necropsy. The LD50value was ranked exceeding 2000 mg/kg b.w.

The LD50-value for acute oral toxicity of the test substance neodecanoic acid tin (2+)salt (2:1) is > 2000 mg/kg body weight.