Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
13 - 27 Aug 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
The analytical purity of the test substance was not specified. Body weight changes could not be not examined.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2-dimethyl-1,3-propanediyl didecanoate
EC Number:
248-688-3
EC Name:
2,2-dimethyl-1,3-propanediyl didecanoate
Cas Number:
27841-06-1
Molecular formula:
C25H48O4
IUPAC Name:
2,2-dimethyl-1,3-propanediyl didecanoate

Test animals

Species:
mouse
Strain:
CD-1
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Wilmington, USA
- Age at study initiation: adult animals
- Fasting period before study: animals were fasted 4 h prior to administration
- Housing: 5 animals of the same sex per cage, in stainless steel wire mesh cages
- Diet: Wayne Lab BloxR, ad libitum
- Water: tap water, ad libitum (analyses performed)
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- 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: 5.5 mL/kg

CLASS METHOD
- Rationale for the selection of the starting dose: upon sponsor's request
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 1 and 4 h after dosing (clinical signs, CNS effects and mortality) and daily for the rest of the observation period. Body weights were recorded at study initiation.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the observation period.
Clinical signs:
No clinical signs of toxicity were observed up to the end of the 14-day observation period.
Body weight:
Effects on body weight could not be examined, because the ear tags of all animals were missing on Day 14.
Gross pathology:
Necropsy revealed no substance-related findings.

Other findings:
Poor grooming was observed.

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.

Categories Display