Registration Dossier
Registration Dossier
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EC number: 500-734-6 | CAS number: 162492-01-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 Jul - 18 Aug 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted in 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted in 2008
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- adopted in 2002
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Schwabach, Germany
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Hexamethylene diisocyanate, trimers, reaction products with 2-hydroxyethyl acrylate
- EC Number:
- 500-734-6
- EC Name:
- Hexamethylene diisocyanate, trimers, reaction products with 2-hydroxyethyl acrylate
- Cas Number:
- 162492-01-5
- Molecular formula:
- C39 H60 N6 O15
- IUPAC Name:
- Hexamethylene diisocyanate, trimers, reaction products with 2-hydroxyethyl acrylate
Constituent 1
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
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9 - 10 weeks
- Weight at study initiation: 173 - 180 g (step 1), 157 - 166 g (step 2)
- Fasting period before study: yes
- Housing: groups in IVC cages, type III H, polysulphone cages, 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
- 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
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: polyethylene glycol 400
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.4 g/mL
- Amount of vehicle (if gavage): 5 mL/kg bw
- Justification for choice of vehicle: Several vehicles were evaluated and preparation and solubility tests were performed (corn oil, sterile water for injection, polyethylene glcol 400 (PEG 400) and 1% carboxymethylcellulose). Only the preparation with PEG 400 yielded a suspension which was considered to be applicable to animals.
- Lot/batch no.: S7106885 (Merck)
MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed several times oin the day of dosing and daily thereafter; individual body weights were examined on day 1 (prior to the administration) and on days 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, morbidity, mortality, body weight
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured during the study period.
- Clinical signs:
- No clinical signs of toxicity were observed up to the end of the 14-day observation period.
- Body weight:
- Body weight gains were within the normal ranges in females during the whole study period.
- Gross pathology:
- Necropsy examination revealed no substance-related findings.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/GHS criteria not met; no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- CLP: not classified
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