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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

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

Test material

Constituent 1
Reference substance name:
Dodecene, hydroformylation products, high-boiling
EC Number:
271-239-8
EC Name:
Dodecene, hydroformylation products, high-boiling
Cas Number:
68526-91-0
Molecular formula:
Unspecified
IUPAC Name:
Reaction products of dodecene, hydroformylation products, high boiling
Details on test material:
- Name of test material (as cited in study report): Oxooel 13
- Physical state: liquid, clear
- Composition of test material: mixture of C13-alcohols, C13-acids and -esters
- Stability under test conditions: yes

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH
- Age at study initiation: ca. 12 weeks
- Weight at study initiation: mean males: 170 g; mean females: 170 g
- Fasting period before study: 16 hrs (water ad libitum)
- Housing: 5 animals per cage
- Diet: Ssniff R
- Water: ad libitum
- Acclimation period: at least one week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26
- Humidity (%): 45-75
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5% Carboxymethylcellulose
Details on oral exposure:
VEHICLE
- Justification for choice of vehicle: according to physiological conditions

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 observations and weighing: - weighing on day 2, day 7 and day 13; - frequency of observations: < 15 min, 15 min, 30 min, 1 hr, 2 hrs, 4 hrs, 5 hrs after substance administration; 2 times daily (working days), once daily (public holidays): check on moribund and dead animals
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
- no mortality observed
Clinical signs:
other: - no clinical signs observed
Gross pathology:
- no abnormalities observed
Other findings:
- Histopathology: no abnormalities detected

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
Oxooel 13 is practically non-toxic after oral administration.
Executive summary:

The study is conducted according to OECD 401. Groups of 5 rats per sex and dose were administered 5000 mg/kg bw of the test substance. No mortality, no clinical signs and no pathological abnormalities were observed.

Conclusion:

Oxooel 13 is practically non-toxic after oral administration.