Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
