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Diss Factsheets

Administrative data

Endpoint:
sub-chronic toxicity: dermal
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
09 Jul - 10 Oct 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (no data on test substance purity; only 2 dose groups, open application, limited parameters examined)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 411 (Subchronic Dermal Toxicity: 90-Day Study)
Deviations:
yes
Remarks:
(no data on test substance purity, only 2 dose groups, open application, limited parameters examined)
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Reference substance name:
Fatty acids, C5-9, tetraesters with pentaerythritol
EC Number:
267-022-2
EC Name:
Fatty acids, C5-9, tetraesters with pentaerythritol
Cas Number:
67762-53-2
IUPAC Name:
67762-53-2
Details on test material:
- Name of test material (as cited in study report): [trade name]
- Substance type: polyol ester
- Physical state/appearance: light yellow liquid
- Analytical purity: no data
- Relative density: 1.00

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Type of coverage:
open
Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
13 weeks
Frequency of treatment:
5 days per week (65 exposures), 24 hours/day, removal of substance on saturdays (once a week)
Doses / concentrations
Remarks:
Doses / Concentrations:
800 and 2000 mg/kg bw/day
Basis:
nominal per unit body weight
No. of animals per sex per dose:
10
(5 additional animals of the control and the high dose group were included for dermal bioavailability experiments only.)
Control animals:
yes, concurrent no treatment

Results and discussion

Effect levels

Dose descriptor:
NOAEL
Effect level:
>= 2 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: highest dose tested

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion