Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Secondary source. Read-across to synthetic amorphous silica.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1958
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
on intact and abraded skin in 0.5 % CMC
GLP compliance:
no
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: albino
Sex:
male/female

Administration / exposure

Type of coverage:
not specified
Vehicle:
CMC (carboxymethyl cellulose)
Details on exposure:
on intact and abraded skin in 0.5 % CMC
Duration of treatment / exposure:
3 wks
Frequency of treatment:
18 h/d, 5 d/wk
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 5000, 10000 mg/(kg bw*d)
Basis:
nominal per unit body weight
No. of animals per sex per dose:
2
Control animals:
yes, concurrent vehicle
Positive control:
Cosmetic talc (10 g/(kg bw*d)

Examinations

Sacrifice and pathology:
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes

Results and discussion

Effect levels

Dose descriptor:
NOAEL
Effect level:
>= 10 000 mg/kg bw/day (nominal)
Sex:
male/female
Basis for effect level:
other: overall effects clinical signs; mortality; body weight; gross pathology; organ weights; histopathology

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

No evidence of systemic toxicity or of gross or microscopic pathology; no significant difference in dermal irritation between control and dose groups

Applicant's summary and conclusion

Executive summary:

In a repeated dose toxicity study via dermal route (Cabot Inc. 1958, see also ECETOC 2006), pyrogenic Cab-O-Sil fluffy showed no evidence of systemic toxicity or of gross or microscopic pathology, and no significant difference in dermal irritation between control and dose groups.