Registration Dossier
Registration Dossier
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EC number: 939-460-0 | CAS number: 1471311-26-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982/06/30 to 1982/08/09
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions. However, little information provided in the report about the test material and how it was stored.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Federal Hazardous Substances Act 16 CFR - P.114
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction product of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and phenol, heptyl derivs.
- EC Number:
- 939-460-0
- Cas Number:
- 1471311-26-8
- Molecular formula:
- Too complex
- IUPAC Name:
- Reaction product of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and phenol, heptyl derivs.
- Test material form:
- liquid: viscous
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 200 - 300g
- Fasting period before study: overnight
- Housing: stainless steel with elevated wire mesh floor
- Diet (e.g. ad libitum): Wayne Lab-Blox ad libitum (with-held overnight prior to dosing)
- Water (e.g. ad libitum): Tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 23
- Humidity (%): 40 - 50
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 28 April 1982 To: 24 May 1982
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- dosed at 5g/kg
- Doses:
- 2g/kg
- 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
- Frequency of observations and weighing: Frequently on day of dosing, twice per day thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: All animals appeared ruffled after 3 hours. Diarrhea and urine staining of the genitalia was observed over the next 24 - 72 hours. The animals appeared essentially recovered after 4 days.
- Gross pathology:
- No treatment related effects
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of the substance is > 2000 mgkg
- Executive summary:
Test Guidance
Acute oral toxicity was investigated using a similar method to that given in 16 CFR 1500.3 of the Federal Hazardous Substances Act Regulations.
Method and Material
A group of ten (5 male and 5 female) albino rats (Sprague-Dawley) were dosed with 2000 mg/kg of the test material by oral gavage. The animals were observed for 14 days after test material administration for signs of toxicity and mortalities. Gross autopsies were performed on all animals that either died within the 14 day observation period or on surviving animals.
Results
The test material gave an LD50> 2000 mg/kg bw. There were no mortalities. All animals appeared ruffled after 3 hours. Diarrhea and urine staining of the genitalia was observed over the next 24 - 72 hours. The animals appeared essentially recovered after 4 days.
Conclusion
The substance is not classified in accordance with CLP Regulation (EC) No 1272/2008..
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