Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Repeated dose toxicity: other routes
Administrative data
- Endpoint:
- short-term repeated dose toxicity: other route
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2021
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- MS1-type bioengineered spider silk nanoparticles do not exhibit toxicity in an in vivo mouse model.
- Author:
- Mackiewicz
- Year:
- 2 021
- Bibliographic source:
- Nanomedicine, 16\5018\51, 1553-1565 (2021)
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- nanospheres from spider silk proteins MSI and H2.1MS1
- Molecular formula:
- not applicable, UVCB
- IUPAC Name:
- nanospheres from spider silk proteins MSI and H2.1MS1
- Details on test material:
- Bioengineered spider silk MSI: based on the sequence of MaSpl from the AC clavipes spider
Bioengineered spider silk H2.1MS1: functionalized MSI silk with the H2.1 peptide
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- female
Administration / exposure
- Route of administration:
- other: retro-orbital
- Vehicle:
- other: PBS
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 20 days
- Frequency of treatment:
- on day 0, 3, 6
Doses / concentrationsopen allclose all
- Dose / conc.:
- 20 mg/kg bw/day
- Dose / conc.:
- 0 mg/kg bw/day
- No. of animals per sex per dose:
- 3 animals per group
- Control animals:
- yes, concurrent vehicle
Examinations
- Sacrifice and pathology:
- Hematological examination: counts of red blood cells, white blood cells (WBCs), and platelets (PLTs)
Biochemical examination: albumin, alkaline phosphatase (ALP), amylase, glucose, total protein and urea
Histopathological evaluation: heart, lungs, liver, kidney and spleen
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- not examined
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 20 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
Applicant's summary and conclusion
- Conclusions:
- No toxicity of systemically administrated bioengineered spider silk nanosphere was observed
- Executive summary:
No toxicity of the systemically administrated spider silk nanosphere was observed.
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.
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