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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
31 Dec 1988 - 18 Jan 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study with acceptable restrictions (analytical purity data on test item not given).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted in 1987
Deviations:
yes
Remarks:
lack of details on test substance
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Isopropyl isodecanoate
EC Number:
269-023-3
EC Name:
Isopropyl isodecanoate
Cas Number:
68171-33-5
Molecular formula:
C21H42O2
IUPAC Name:
Propan-2-yl 16-methylheptadecanoate
Details on test material:
- Name of test material (as cited in study report): Only trade name given
- Physical state: colourless liquid
- Analytical purity: no data
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: IFFA CREDO, L'Arbresle, France
- Age at study initiation: 2 month old
- Weight at study initiation: 172.2 ± 4.8 g (males) and 177.4 ± 4.9 g (females)
- Fasting period before study: 16 hours before treatment and 3 hours following treatment
- Housing: groups of 5 animals of same sex per cage, in Makrolon cages (46.5 x 31 x 19 cm) with floors covered with soft wood sawdust
- Diet: UAR A04C diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): 14
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality, twice a day; clinical signs, daily; body weight, on day 4 prior treatment, on day 0 just before application, and thereafter, on day 3, 7 and 14.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.
Gross pathology:
Gross pathology revealed no substance-related findings.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified