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EC number: 500-105-6 | CAS number: 39423-51-3 1 - 6.5 moles propoxylated
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
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Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-03-01 to 2012-03-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- no
Test material
- Test material form:
- liquid
- Details on test material:
- Name of test material: Trimethylolpropanepoly(oxypropylene)triamine
EC no.: 500-105-6
CAS no.: 39423-51-3
Physical state: clear colourless liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 1L708
- Composition of test material, percentage of components: 96% primair amine, 0.08 wt%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature, 15 to 30°C
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan
- Age at study initiation: 9 to 11 weeks at start of dosing
- Weight at study initiation: 195 to 221 grams
- Fasting period before study: overnight
- Housing: Animals were group housed by sex upon receipt and individually housed during the study. No other species were kept in the same room.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: a minimum of 5 days prior to dosing.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 24°C
- Humidity (%): 20 to 63%
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
IN-LIFE DATES: From: 1 March 2012 To: 30 March 2012
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- at 175mg/kg dose only (low dose)
- Details on oral exposure:
- Dose preparation:
The proper amount of the test article was measured according to volume since it was a liquid, and was allocated/dosed neat as received from the Sponsor at 2000 and 550 mg/kg with a pH = 7. The stock bottle was inverted several times prior to dispensing. At 175 mg/kg the test article was dissolved in distilled water (175 mg brought to a volume of 5 mL). The resulting clear liquid had a pH equal to 12. - Doses:
- 175, 550 or 2000 mg/kg body-weight
- No. of animals per sex per dose:
- A total of 6 females: 175 (1), 550 (3) and 2000 mg/kg (2)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality checks were made at least once daily. Clinical observations were recorded prior to dosing, as well as at 30 minutes, 4 hours post-dose, and daily thereafter through day 15. Body weights were recorded on the day of dosing (day 1), and on days 8 and 15, or upon death. All surviving rats were euthanized by CO2 asphyxiation and necropsied on Day 15.
- Necropsy of survivors performed: yes - Statistics:
- The LD50 was calculated test using the AOT425StatPgm developed by Westat May, 2001.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 550 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 123.9 - 3 930
- Mortality:
- For the dose of 175 mg/kg, no mortality was observed. One of three animals receiving the test article at 550 mg/kg was found dead and both animals at 2000 mg/kg were found dead. All three deaths occurred by the 30 minute observation time point on day 1.
- Clinical signs:
- other: No clinical signs were observed and all surviving animals appeared normal throughout the study.
- Gross pathology:
- Terminal necropsy revealed no visible lesions in the surviving animals at 175 and 550 mg/kg. Necropsy of the animals found dead revealed test article visible in the stomach but no other visible lesions.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Based on the results of this study, the oral LD50 for the test substance in rats was estimated to be 550 mg/kg (95% PL Confidence Interval of 123.9 to 3930 mg/kg). Therefore, the test substance is considered to be classified as category 4 according to the CLP regulation.
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