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EC number: 500-105-6 | CAS number: 39423-51-3 1 - 6.5 moles propoxylated
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-05 to 2012-06
- 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
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
- Purity test date: 21/11/2011
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temp (19-27°C)
- Stability under test conditions: no data
OTHER SPECIFICS:
- Analytical purity: 96% primary amine
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 190-234 g
- Fasting period before study: no data
- Housing: grouped by sex upon receipt; individually housed upon assignment to study
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: min 5d prior to dosing
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23°C
- Humidity (%): 24-89%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12h light / 12h dark
IN-LIFE DATES: From: 31 May 2012 To: 14 June 2012
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: > 10%
- Type of wrap if used: elastic bandage, secured with non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped appropriately with gauze and water
- Time after start of exposure: 24h (+/- 0.5h)
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1000 mg/kg
- Concentration (if solution): 0.978 g/ml
- Constant volume or concentration used: yes
VEHICLE: no vehicle - Duration of exposure:
- 24h (+/- 0.5h)
- Doses:
- 1000 mg/kg
- No. of animals per sex per dose:
- 5 per sex
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
mortality: once daily
clinical observations: immediately after unwrap + daily thereafter through day 15
weighing on day1, day8, day15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, external body surface, all orifices, thoracic, abdominal and pelvic cavaties and their content.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 1 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality observed
- Mortality:
- No mortality observed
- Clinical signs:
- other: 7/10: some signs of irritation at the application site starting on day 4, with all irritation resolved by day 14. No necrosis observed
- Gross pathology:
- No visible lesions observed in the animals at terminal necropsy
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Based on the results of the acute dermal toxicity study in rats with the test substance, the estimated LD50 was considered to be greater than 1000 mg/kg bw. Therefore, the substance is considered to be classified as category 4 according to CLP regulation.
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