Registration Dossier
Registration Dossier
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EC number: 201-077-5 | CAS number: 78-04-6
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 5th January to 25th January 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable well-documented study report which meets basic scientific principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Dibutyltin maleate
- EC Number:
- 201-077-5
- EC Name:
- Dibutyltin maleate
- Cas Number:
- 78-04-6
- Molecular formula:
- C12H20O4Sn
- IUPAC Name:
- dibutylstannanebis(ylium) (2Z)-but-2-enedioate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Tif: RAIf (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland.
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 155-210g
- Fasting period before study: Prior to dosing, the animals were fasted overnight
- Housing: The animals were kept under conventional laboratory conditions. They were caged in groups of 5 in macrolon cages type 3 with standardized soft wood bedding (Societe Parisienne des sciures, Pantin).
- Diet: Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland) was provided ad libitum
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 15%
- Air changes (per hr): Approximately 15 air changes/h.
- Photoperiod (hrs dark / hrs light): 12 hours lignt/day
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% CMC + 0.1% Tween 80 in dist. water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25, 50, 100 and 250 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg bw - Doses:
- 250, 500, 1000, 2500 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days or until all symptoms have disappeared, whichever lasts longer.
- Frequency of observations and weighing:
Mortality = daily, a.m. and p.m. on working days
Signs and Symptoms = daily
Body weight = on days 1, 7, 14 and at death
- Necropsy of survivors performed: Yes, spontaneously dying animals were submitted to a gross necropsy as soon as possible; survivors at the end of the observation period. - Statistics:
- From the body weights, the group means and their standard deviations were calculated.
The LD50 including the 95% confidence limit were computed by the logit metnod.
Results and discussion
- Preliminary study:
- n/a
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 647 mg/kg bw
- 95% CL:
- 233 - 1 254
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 422 mg/kg bw
- 95% CL:
- 11 - 932
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 510 mg/kg bw
- 95% CL:
- 263 - 777
- Mortality:
- Mortality (number dead/total number tested):
250 mg/kg bw: Males, 0/5; Females, 1/5
500 mg/kg bw: Males, 5/5; Females, 1/5
1000 mg/kg bw: Males, 4/5; Females, 4/5
2500 mg/kg bw: Males, 5/5; Females, 5/5 - Clinical signs:
- other: Within 1 hour following dosing, animals all treatment groups exhibited dyspnoea, curved position, and ruffled fur. Other clinical signs and symptoms reported included sedation, exophthalmus and diarrhea. All surviving animals in the 250 and 500 mg/kg bw g
- Gross pathology:
- No compound-related gross organ changes were reported.
- Other findings:
- No data
Any other information on results incl. tables
Within 1 hour following dosing, animals in all treatment groups exhibited dyspnoea, curved position, and ruffled fur. Other clinical signs and symptoms reported included sedation, exophthalmus and diarrhea. All surviving animals in the 250 and 500 mg/kg bw groups recovered by Day 9. There was no decrease in body weight gain for males at 250 mg/kg bw or for females at 250 and 500 mg/kg bw.
Mortality (number dead/total number tested):
250 mg/kg bw: Males, 0/5; Females, 1/5
500 mg/kg bw: Males, 5/5; Females, 1/5
1000 mg/kg bw: Males, 4/5; Females, 4/5
2500 mg/kg bw: Males, 5/5; Females, 5/5
Animals at 500 mg/kg and above died within 4-7 days following dosing. One female at 250 mg/kg bw died on day 8.
No compound-related gross organ changes were reported.
The acute lethal dose (LD50) and 95% confidence limits were reported as:
Males: 422 (11 - 932) mg/kg bw.
Females: 647 (233 - 1254) mg/kg bw
Both sexes: 510 (263 - 777) mg/kg bw.
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU-GHS (CLP), Regultion (EC) No. 1272/2008
- Conclusions:
- The acute lethal dose (LD50) and 95% confidence limits for dibutyltin maleate (DBTM) were reported as:
Males: 422 (11 - 932) mg/kg bw
Females: 647 (233 - 1254) mg/kg bw
Both sexes: 510 (263 - 777) mg/kg bw - Executive summary:
In an acute LD50 in the rat study, the test material, dibutyltin maleate, was found to have an LD50 of 510 mg/kg bw with confidence limits of 263 - 777 mg/kg bw in males/female. The LD50 for males is 422 mg/kg bw and for females 647 mg/kg bw.
Within 1 hour following dosing, animals all treatment groups exhibited dyspnoea, curved position, and ruffled fur. Other clinical signs and symptoms reported included sedation, exophthalmus and diarrhea. All surviving animals in the 250 and 500 mg/kg bw groups recovered by Day 9. There was no decrease in body weight gain for males at 250 mg/kg bw or for females at 250 and 500 mg/kg bw. Animals at 500 mg/kg bw and above died within 4-7 days following dosing. One female at 250 mg/kg bw died on day 8.
No compound-related gross organ changes were reported.
The study was conducted to the OECD Guideline no. 401.
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