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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:
1994-10-27 to 1994-11-17
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified reliable without restriction. It was conducted according to OECD 401 guideline and followed GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
1-dodecene dimer, hydrogenated
IUPAC Name:
1-dodecene dimer, hydrogenated
Details on test material:
- Name of test material (as cited in study report)
- Substance type: 1-dodecene dimer, hydrogenated
- Physical state: liquid, clear colourless
- Purity test date:
- Lot/batch No.: C1527-04-2
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd., Kent, U.K.
- Age at study initiation: 8 weeks
- Weight at study initiation: Male: 207-234 grams; Female: 202-219 grams
- Fasting period before study: overnight pre-dosing and 2 hours post-dosing
- Housing: Groups of 5 by sex in polypropylene cages
- Diet (e.g. ad libitum): Rat and Mouse Expanded Diet No. 1, Special Diets Service Ltd., Essex, U.K. ad libitum
- Water (e.g. ad libitum): Mains drinking water ad libtium
- Acclimation period: 7 Days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21˚C
- Humidity (%): 49-54%
- Air changes (per hr): 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light

IN-LIFE DATES: From: 1994-10-27 To: 1994-11-17

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 6.28 mL/kg (5000 mg/kg bw)
Doses:
single dose of 5000 mg/kg bw
No. of animals per sex per dose:
5/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality and clinical toxicity observed at 1, 2.5, 4 hours, and then once daily. Body weight recorded on Days 0, 7, and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Based on absence of mortality and lack of adverse treatment-related effects observed in male and female rats
Mortality:
No mortality was observed through the study period in male or female rats
Clinical signs:
No signs of adverse treatment-related clinical toxicity were observed through the study period.
Body weight:
Body weight of male and female rats remained unaffected through the study period.
Gross pathology:
Gross necroscopy ate termination did not reveal any significant findings.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Based on the absence of mortality and lack of adverse treatment-related clinical toxicity, the acute oral LD50 of 1-dodecene, dimer hydrogenated is considered to be >5000 mg/kg bw in the rat.
Executive summary:

In an acute oral toxicity study (Driscoll, R., 1995; Klimisch score = 1), 5000 mg/kg bw of 1 -dodecene dimer, hydogenated was orally administered via gavage to Sprague-Dawley rats (5/sex). The animals were observed over a period of 14 days for mortality and signs of clinical toxicity.

No mortality was observed in male or female rats during the study. The test animals did not exhibit any signs of adverse clinical toxicity. Body weights remained unaffected through the test period and gross necroscopy at termination did not reveal any remarkable findings.

Based on the absence of test material related mortality and lack of adverse signs of clinical toxicity, the acute oral LD50 for 1 -dodecene dimer, hydrogenated is considered to be >5000 mg/kg body weight in the rat.