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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:
key study
Study period:
17 Nov 1998 - 25 Feb 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted in 1987
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Dodecanoic acid, ester with 1,2-propanediol
EC Number:
253-462-2
EC Name:
Dodecanoic acid, ester with 1,2-propanediol
Cas Number:
37321-62-3
Molecular formula:
C15H30O3 C27H52O4
IUPAC Name:
Dodecanoic acid, ester with 1,2-propanediol

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
- Females (if applicable) nulliparous and non-pregnant: not stated
- Age at study initiation: 5-7 weeks
- Weight at study initiation: females: 131-148 g, males 172-188 g
- Fasting period before study: yes, overnight.
- Housing: groups of up to 5 of the same sex in polycarbonate cages type M1 on dust-free sawdust bedding
- Diet (e.g. ad libitum): pelleted complete diet, ad libitum
- Water (e.g. ad libitum): filtered tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 26.1 to 89.7
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: 08 Dec 1998 - 22 Dec 1998

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2.18 mL/kg
Doses:
2003 mg/kg
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: mortality and abnormal clinical signs were examined 15 min, 1 h, 2 h, and 4 h after administration and thereafter once daily.
- Frequency of weighing: on the day before treatment, immediately before treatment (day 1) and on days 8 and 15.
- Necropsy of survivors performed: yes, on day 15.
Statistics:
None.

Results and discussion

Preliminary study:
Doses of 505, 1002 and 2003 mg/kg administered to one male and one female rat per dosage resulted in no mortalities during an observation period of 7 days after administration.
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Remarks:
rat
Effect level:
> 2 003 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No mortality was observed.
Clinical signs:
other: No abnormal clinical signs in any of the treated animals during the entire observation period.
Gross pathology:
No macroscopic findings at necropsy.

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.