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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Method: BASF Test
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Dodecene, branched
EC Number:
306-479-5
EC Name:
Dodecene, branched
Cas Number:
97280-83-6
Molecular formula:
C12 H24
IUPAC Name:
(2Z)-4-methylundec-2-ene
Details on test material:
- Name of test material (as cited in study report): Isododecene

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, 7950 Biberach, FRG
- Age at study initiation: young adult animals
- Weight at study initiation: comparable weight (+/- 20% of the mean weight)
mean weight of the males: 188 g; mean weight of the females: 187 g
- Housing: 5 animals per cage, stainless steel wire mesh cages (type DK-III, without bedding)
- Diet (e.g. ad libitum): ad libitum (KLIBA laboratory diet), the animals were given no feed about 16 hours before administration
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 -24°C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12/12
There were no deviations from these ranges which influcenced the results of the study

Animal identification: Identification of groups using cage cards

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
(0.5 % aqueous carboxymethyl cellulose)
- Concentration in vehicle: 20 g/100 ml
- Administration volume (if gavage): 10 ml/kg
- Justification for choice of vehicle: aqueous formulation corresponds to the physiological medium




Doses:
2000 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 and weighing: Recording of signs and symptoms occured several times on the day of administration and at least
once each workday; (check for moribund and dead animals twice each workday and once on holidays)
- Necropsy of survivors performed: yes
- Other examinations performed:
determination of body weight: at the beginning of the study and on d 7 and d 13.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
All animals survived.
Clinical signs:
other: No abnormalities were observed.
Gross pathology:
No pathological findings were noted.

Applicant's summary and conclusion