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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
20 Jul 1984-15 Oct 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: comparable to guideline study with acceptable restrictions
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Objective of study:
distribution
Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD 413
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
112945-52-5
EC Number:
601-216-3
Cas Number:
112945-52-5
IUPAC Name:
112945-52-5
Constituent 2
Reference substance name:
Silica, amorphous, fumed
IUPAC Name:
Silica, amorphous, fumed
Details on test material:
- Name of test material (as cited in study report): Aerosil 200
- Analytical purity: > 99.8%
Radiolabelling:
no

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: aerosol
Vehicle:
unchanged (no vehicle)
Duration and frequency of treatment / exposure:
6 h/day, 5 days/week for 13 weeks
Doses / concentrations
Remarks:
Doses / Concentrations:
1.3, 5.9 or 31 mg/m3 (analytical concentration)
No. of animals per sex per dose / concentration:
no data
Control animals:
yes

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on distribution in tissues:
Silica could be detected in lungs only in relatively small amounts at the end of the exposure period, on the average 0.2 mg in all animals of the 30-mg groups. Only one male exposed to 30 mg/m3 showed a small amount of silica in the regional lymph node. During the post-exposure observation period, no silica could be recovered from any animal.

Applicant's summary and conclusion