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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
sub-chronic toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1965
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1965
Report date:
1965

Materials and methods

Test guideline
Qualifier:
no guideline available
Guideline:
other: The study was performed in 1965 before any Guideline was available.
GLP compliance:
no
Remarks:
The study was performed 1965, before GLP came into force.
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
[3aR-(3aα,5aβ,9aα,9bβ)]decahydro-3a,6,6,9a-tetramethylnaphth[2,1-b]furan-2(1H)-one
EC Number:
209-269-0
EC Name:
[3aR-(3aα,5aβ,9aα,9bβ)]decahydro-3a,6,6,9a-tetramethylnaphth[2,1-b]furan-2(1H)-one
Cas Number:
564-20-5
Molecular formula:
C16H26O2
IUPAC Name:
[3aR-(3aα,5aβ,9aα,9bβ)]decahydro-3a,6,6,9a-tetramethylnaphth[2,1-b]furan-2(1H)-one
Test material form:
solid

Test animals

Species:
other: rats and monkeys
Strain:
other: Sprague-Dawley rats and African green monkeys
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
not specified
Vehicle:
air
Remarks on MMAD:
No specified
Details on inhalation exposure:
Each group of animals was exposed separately in specially constructed Lucite inhalation chambers. the test vapor was prodcued in a one-litre glass distillation flask completely enclosed in a spherical heating mantle. The sclareolide was heated to above the melting point in order to achieve a high rate of vapor production. Then, dry preheated metered air was passed over the surface of the melted test material and into the exposure chamber via a large diameter glass tube heated with electrical heating tape to prevent crystallization of the vapors. Additional metered air was mixed with the vapor stream when necessary to achieve the desired final concentration.
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
90 days, six hours per day, five days a week
Doses / concentrationsopen allclose all
Dose / conc.:
0.001 mg/L air
Dose / conc.:
0.01 mg/L air
Dose / conc.:
0.1 mg/L air
No. of animals per sex per dose:
Four groups were used in the study. Each group consisted of:
4 monkeys (2 males and 2 females)
20 rats (10 males and 10 females)
Control animals:
yes

Examinations

Observations and examinations performed and frequency:
During the course of the experiment a number of biological parameters were investigated: body weight, blood hematology, blood chemistry.
Sacrifice and pathology:
A complete necropsy was performed at the completion of the experiment. Gross pathology was assessed.

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
Vomiting occurred in some monkeys at the higher dose levels of 0.01 and 0.1 mg/L air. This reaaction was mild in nature and occurred intermittently during the last half of the ninety-day study. No evidence of the vomiting effect was noted in rats.
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
no effects observed
Neuropathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Other effects:
not specified

Effect levels

Key result
Dose descriptor:
NOAEC
Effect level:
>= 0.1 mg/L air
Based on:
test mat.
Remarks:
maximum concentration tested
Sex:
male/female

Applicant's summary and conclusion

Conclusions:
No adverse effects on body weight, clinical pathology or histopathology in African green monkeys or Sprague-Dawley rats exposed to vapors at 0.001, 0.01, 0.1 mg/L air, 6 hrs/day, 5 days a week, for 90 days were observed.