Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Remarks:
- intraperitoneally injection
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-03-06 - 2012-04-10
- Reliability:
- 1 (reliable without restriction)
- Justification for type of information:
- Justification for read across:
This increased molecular weight of the recombinant spider silk protein eADF4(C48-CS25C) is not expected to cause any adverse effects on acute and chronic oral and dermal toxicity, irritating properties regarding skin and mucous membranes or mutagenicity/genotoxicity. For example, the bioavailability and thus systemic uptake of the protein will be lowered with increasing molecular weight of the substance (see attached justification).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- intraperitoneally injection to female NMRI mice
- GLP compliance:
- no
- Limit test:
- yes
Test material
- Reference substance name:
- Recombinant spider silk protein eADF4(C16) derived from E. Coli by fermentation
- Molecular formula:
- not applicable, UVCB
- IUPAC Name:
- Recombinant spider silk protein eADF4(C16) derived from E. Coli by fermentation
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- female
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- physiological saline
- Details on exposure:
- intraperitoneally injection
- Doses:
- 0 and 250 mg/kg bw
- No. of animals per sex per dose:
- 5 animals per dose
- Control animals:
- yes
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 250 mg/kg bw
- Based on:
- test mat.
- Mortality:
- none
- Clinical signs:
- mild piloerection observed in single animals of the test item group on study days 2-3, no direct test item related findings were noted.
- Body weight:
- The mean body weight development was slightly negatively affected one day following treatment with SSPl but a recovery within the following 2 days was noted. In summary, these findings were either of minor manifestation or of a transient and recovering nature following single administration of the test item.
- Gross pathology:
- No macroscopic findings were observed in any animal from either group. No significant differences in organ weights between the test item and the control group were observed.
Applicant's summary and conclusion
- Conclusions:
- No adverse effects were observed in this study.
- Executive summary:
No adverse effects were observed in this study.
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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