Registration Dossier
Registration Dossier
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: 923-201-3 | CAS number: 1192143-92-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-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 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted in 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Landesinstitut für Arbeitsschutz und Produktsicherheit, München, Germany
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- UMA121
- IUPAC Name:
- UMA121
- Reference substance name:
- Propanol, oxybis-, oligomeric reaction products with 1,1'-methylenebis[isocyanatobenzene], propylene glycol monomethacrylate-blocked
- EC Number:
- 923-201-3
- Cas Number:
- 1192143-92-2
- Molecular formula:
- C29H34N2O8 C50H58N4O13 C71H82N6O18 C92H106N8O23 C113H130N10O28
- IUPAC Name:
- Propanol, oxybis-, oligomeric reaction products with 1,1'-methylenebis[isocyanatobenzene], propylene glycol monomethacrylate-blocked
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: Wistar Crl: WI(Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: 8 - 10 weeks
- Weight at study initiation: 154 - 167 g
- Fasting period before study: Food was withheld for 16 to 19 h before until 4 h after dosing.
- Housing: The animals were housed in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding.
- Diet: Altromin 1324 maintenance diet for rats and mice, ad libitum
- Water: tap water, sulphur acidified to a pH value of approximately 2.8, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES:
- Step 1
From: 27 Jul 2012
To: 10 Aug 2012
- Step 2
From: 16 Aug 2012
To: 30 Aug 2012
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.2 g/mL
- Justification for choice of vehicle: The vehicle was chosen due to its non-toxic characteristics.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 females (3/step)
- Control animals:
- other: not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made several times on the day of dosing (especially during the first 30 min until 4 h after application) and once daily thereafter until the end of the study period. Animals were weighed on Days 1, 8, and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: cut-off value
- Mortality:
- All animals survived until the end of the observation period.
- Clinical signs:
- other: After application of the test substance, slightly reduced spontaneous activity and slight piloerection were noticed in all animals. The effects were reversible within 4 h. Moreover, the first set of animals showed bradykinesia, kyphosis and half eyelid-cl
- Gross pathology:
- Necropsy revealed no substance-related findings.
Any other information on results incl. tables
Table 1: Absolute Body Weights and Body Weight Gain
Animals |
Body weight (g) |
Increase (%) |
|||
Step |
Number |
Day 1 |
Day 8 |
Day 15 |
Day 1 - 15 |
1 |
1 |
156 |
187 |
198 |
27 |
2 |
154 |
176 |
185 |
20 |
|
3 |
165 |
175 |
200 |
21 |
|
2 |
4 |
164 |
191 |
208 |
27 |
5 |
167 |
189 |
202 |
23 |
|
6 |
164 |
185 |
197 |
20 |
|
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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.
