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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
29 Aug - 21 Sep 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The analytical purity of the test substance was not reported.

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 Feb 1987
Deviations:
yes
Remarks:
analytical purity of the test substance was not reported
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-octyldodecyl myristate
EC Number:
245-205-8
EC Name:
2-octyldodecyl myristate
Cas Number:
22766-83-2
Molecular formula:
C34H68O2
IUPAC Name:
2-octyldodecyl myristate

Test animals

Species:
rat
Strain:
other: OFA.Sprague-Dawley (IOPS Caw)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Iffa-Crédo, L'Arbresle, France
- Age at study initiation: 5 - 7 weeks
- Weight at study initiation: 145.0 g (mean, females) and 164.4 g (mean, males)
- Fasting period before study: 18 h
- Housing: animals were caged in groups of 5/sex in type FI polycarbonate cages (365 mm x 225 mm x 180 mm). Bedding was changed weekly.
- Diet: complete pelleted rat-mouse maintenance diet U.A.R. formule A.04 CR, U.A.R. (Epinay-S/Orge, France), ad libitum
- Water: softened and filtered mains drinking water, ad libitum
- Acclimation period: 10 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 35 mL/kg bw
Doses:
29.75 g/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: observations of mortality and signs of toxicity were made 15 minutes and 1, 2 and 4 hours after administration, and daily thereafter; animals were weighed on Day -1, Day 1 prior to dosing and on Day 8 and 15.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 29 750 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:
No substance-related findings were noted during the necropsy and histopathological examination.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008