1-Tetradecene, polymer with 1-dodecene, distn. residues, hydrogenated, C36-84 fraction

Acute Toxicity: oral

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

Test material information

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:

other: No signs of adverse treatment-related clinical toxicity were observed 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.