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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

For toxicity after repeated exposure to the protein, the substance will have to be bioavailable in sufficient concentration to cause an adverse effect. This requires that the protein will have to be bioavailable by absorption via relevant routes of exposure. Therefore repeated dose toxicity of spider silk protein is not to be expected. In addition, additional data are available from studies with silk powder and fibroin from the silkworm Bombix Mori. No adverse effects were observed up to the highest tested concentrations.


 

Key value for chemical safety assessment

Toxic effect type:
dose-dependent

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2021
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
6-week oral administration
GLP compliance:
not specified
Remarks:
not reported, publication
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male
Route of administration:
oral: gavage
Vehicle:
not specified
Duration of treatment / exposure:
6 weeks
Frequency of treatment:
every two days
Dose / conc.:
0 mg/kg bw/day (nominal)
Dose / conc.:
2 000 mg/kg bw/day (nominal)
No. of animals per sex per dose:
10 groups, 6 rats per group
Control animals:
yes
Observations and examinations performed and frequency:
Mortality, body weights and blood glucose level were recorded every week.
Hematological values and lipid profile were recorded in the last week.
Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Key result
Dose descriptor:
NOAEL
Effect level:
> 2 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male
Basis for effect level:
other: no effects observed
Key result
Critical effects observed:
no
Conclusions:
Silkworm powder did not exhibit any toxicity in the reported study.
Executive summary:

Silkworm powder did not exhibit any toxicity in the reported study.


 

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
2 000 mg/kg bw/day
Study duration:
subacute
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

The substance has not to be classifed for specific target organ toxicity based an all available data.