Registration Dossier
Registration Dossier
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EC number: 500-734-6 | CAS number: 162492-01-5
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 Jul 03 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 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted in 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- adopted in 2008
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Schwabach, Germany
- Test type:
- standard acute 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:
- male/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: 7 - 8 weeks (males), 8 - 9 weeks (females)
- Weight at study initiation: 220 - 255 g (males), 211 - 220 g (females)
- Fasting period before study: no
- Housing: individual 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 2.8, ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: approximately 10%
- Type of wrap if used: The test material was held in contact with the skin with a gauze-dressing and non-irritating tape. An additional dressing was used for fixation in a suitable manner.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test material was removed with aqua ad iniectabilia.
- Time after start of exposure: 24 h
TEST MATERIAL
The test material was used as delivered. - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw/day
- No. of animals per sex per dose:
- 5
- 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 on the day of dosing and once daily thereafter; individual body weights were examined on day 1 (prior to the application) and on days 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 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. Small testes and epididymides was observed in 1/5 male. This was an incidental finding and not considered to be test substance-related.
- Other findings:
- Erythema grade 1 was observed in 4/5 female animals and desquamation was observed in 1/5 female animals on study day 2. All signs of irritation were were reversible within 3 study days.
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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