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Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
one-generation reproductive toxicity
Remarks:
based on test type (migrated information)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
Start: 15 Oct. 1962
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Significant methodological deficiences, acceptable as screening

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1963
Report Date:
1963

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 415 [One-Generation Reproduction Toxicity Study (before 9 October 2017)]
Deviations:
yes
Remarks:
no complete one generation study according to current standards: too low number of animals and examinations, one dose only, dose selection unclear (relatively low dose selected).
Principles of method if other than guideline:
Method:
5 instead of 20 females, 1 male per 5 females (mating ratio 1:5 instead of 1:2); mating over 14 d, only 1 male used per treated and control group
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Aerosil, not further specified, hydrophilic: CAS-Name: Silica, amorphous, fumed, crystalline free, CAS-No. 112945-52-5

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Duration of treatment / exposure:
Exposure period: 6 months
Premating exposure period (males): 4.5 months
Premating exposure period (females): 4.5 months
Duration of test: 6 months
Frequency of treatment:
daily
Details on study schedule:
Number of generation studies: 1
Doses / concentrations
Remarks:
Doses / Concentrations:
497 mg/(kg bw*d) (m); 509 mg/(kg bw *d)(f)
Basis:

No. of animals per sex per dose:
5 instead of 20 females, 1 male per 5 females
Control animals:
yes

Results and discussion

Results: P0 (first parental animals)

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
497 mg/kg bw/day
Sex:
male/female

Results: F1 generation

Effect levels (F1)

Dose descriptor:
NOAEL
Generation:
F1
Effect level:
497 mg/kg bw/day
Sex:
male/female

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

Result: negative

Parents: No clinical symptoms; no mortality,no abnormalities in  body-weight gain and feed consumption, no haematological findings.
 
In pups during lactation [total: 45 and 37 (control), resp.], no behavioral or developmental or structural abnormalities.
 

Applicant's summary and conclusion