Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 Jun - 20 Aug 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Limited report details, no test substance purity reported

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted in 1981
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

1
Chemical structure
Reference substance name:
Fatty acids, C16-18, isononyl esters
EC Number:
292-960-4
EC Name:
Fatty acids, C16-18, isononyl esters
Cas Number:
91031-57-1
Molecular formula:
C25H50O2 C27H54O2
IUPAC Name:
Reaction mass of 7-methyloctyl hexadecanoate and 7-methyloctyl octadecanoate
Test material form:
liquid
Specific details on test material used for the study:
Liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: young adult
- Weight at study initiation: mean BW on the day of application, prior to application: 176 g in males, 160 g in females
- Fasting period before study: fasted for 16 h prior application and 3 h after application
- Housing: Makrolon 3 cages with soft wood granulate
- Diet: Altromin Haltungsdiät 1324, Altromin, Lage, Germany, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): approx. 45-60
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Remarks:
Oleum Arachidis DAB 7 (Lamotte, Bremen, Germany)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50% (g/v)

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
Doses:
5000 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 clinical observations: several times on the day of application, and thereafter twice daily throughout the 14 days of observation
- Frequency of mortality recording: 1, 2, 7, and 14 days after application
- Frequency of weighing: prior to and 2, 7, 14 days after application
- Necropsy of survivors performed: yes, after euthanasia using ether
Statistics:
Not required

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 was observed during the observation period.
Clinical signs:
Reduced activity and piloerection was observed in all 10 animals for 3-8 hours after application.
Body weight:
Mean body weights increased in males as well as in females.
Gross pathology:
No abnormal findings.

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.