Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20th August 1980 - 29th September 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not applicable
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): TK 10701
- Molecular formula (if other than submission substance): N/A
- Molecular weight (if other than submission substance): N/A
- Smiles notation (if other than submission substance): N/A
- InChl (if other than submission substance): N/A
- Structural formula attached as image file (if other than submission substance): N/A
- Substance type: Organotin
- Physical state: Liquid
- Main Compound: dibutyltinbis(2-ethylhexylthioglycolate)
- Analytical purity: 61.8 %
- Impurities (identity and concentrations): monobutyltintris(2-ethylhexylthioglycolate) 25.3 %, epoxidised soybean oil 12.9 %
- Isomers composition: N/A
- Purity test date: NDA

Test animals

Species:
rat
Strain:
other: Tif:RAIf(SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Raised on the experimental premises
- Age at study initiation: 7 - 8 weeks old
- Weight at study initiation: Mean male = 189g Mean female = 174g
- Fasting period before study: Overnight before study
- Housing: Macrolon cages (type 3)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: minimum of 4 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 ºC
- Humidity (%): 55 ± 10%
- Air changes (per hr): NDA
- Photoperiod (hrs dark / hrs light): 10 hours light / 14 hours dark.


IN-LIFE DATES: From: 20th August 1980 To: 29th September 1980

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
polyethylene glycol
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw

Doses:
100, 300, 1000, 2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 7 and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Physical condition
Statistics:
Confidence limits were calculated by the logit model

Results and discussion

Preliminary study:
not applicable
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
396 mg/kg bw
95% CL:
> 174 - < 810
Mortality:
100 mg/kg - 2 females died
300 mg/kg - 1 male and 2 females died
1000 mg/kg - 3 males and 5 females died
2000 mg/kg - 4 males and 5 females died
Clinical signs:
Clinical signs observed included sedation, dyspnoea, exophthalmos, ruffled fur, diarrhoea and affected body positions.
Body weight:
mean 14 day body weights:

Male: 100 mg/kg = 277g, 200 mg/kg = 232 g, 1000 mg/kg = 226 g, 2000 mg/kg = 256g
Female 100 mg/kg = 201 g, 200 mg/kg = 151 g
Gross pathology:
No substance related gross organ changes were seen.
Other findings:
No information provided.

Any other information on results incl. tables

Table 1: Rate of deaths

Dose (mg/kg) Sex Total number of animals in group Total number of animals dead Death rate (%) Number of animals died within
Hours after treatment Days after treatment
1 2 3 5 24 2 3 4 5 6 7 8 9 10 11 12 13 14 15
100 Male 5 0 0                                      
300 5 1 20                 1                    
1000 5 3 60                 2 1                  
2000 5 4 80                 1 3                  
100 Female 5 2 40             2                        
300 5 2 40               1   1                  
1000 5 5 100                 3 1   1              
2000 5 5 100             1 2 2                    

Applicant's summary and conclusion

Interpretation of results:
moderately toxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 of TK 10701 in rats of both sexes observed over a period of 14 days is 396 (174 - 180) mg/kg. The substance is therefore classified as R22 - Harmful if swallowed, according to 67/548/EEC.
Executive summary:

In an acute oral toxicity study, groups of male and female 7 - 8 week old rats were given a single oral dose of TK 10701 in propylene glycol. Doses of  100, 200, 1000 and 2000 mg/kg bw and observed for 14 days.

The study was performed to a method comparable to OECD Guideline 401 (Acute Oral Toxicity).

The acute oral LD50 of TK 10701 in rats of both sexes observed over a period of 14 days is 396 (174 - 180) mg/kg. The substance is therefore classified as R22 - Harmful if swallowed, according to 67/548/EEC.