Branched hexatriacontane

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 as reliable without restrictions because the study was conducted according to OECD 401 and other guidelines and was GLP compliant.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

151006-62-1

Cas Number:

151006-62-1

IUPAC Name:

151006-62-1

Details on test material:

This substance is very similar with regard to health endpoints to the substance being registered.
- Name of test material (as cited in study report): Alkane 4
- Substance type: Poly alpha olefin (1-dodecene trimer, hydrogenated)
- Physical state: Liquid
- Analytical purity: Not reported
- Lot/batch No.: C1527-04-4
- Stability under test conditions: Not reported
- Storage condition of test material: Room temperature
- Other: Clear colourless liquid

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 (U.K.) Ltd.
- Age at study initiation: 8 weeks
- Weight at study initiation: Male: 209-224 grams; Female: 200-213 grams
- Fasting period before study: Overnight prior to dosing and 2 hours post dosing
- Housing: Groups of 5 in grid bottom polypropylene cages
- Diet (e.g. ad libitum): Rat and Mouse Expanded Diet No. 1 (Special Diet Services Ltd, U.K.) ad libitum except during fasting
- Water (e.g. ad libitum): ad libitum
- Acclimation period: ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21°C
- Humidity (%): 49-54%
- Air changes (per hr): 15 per hr
- 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: 6.14 mL/kg (5000 mg/kg); volume calculated based on individual body weight

Doses:

5000 mg/kg

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: Clinical signs and mortality: 1, 2.5 and 4 hours post dosing and once daily thereafter for 14 days; Body weight: Days 0, 7, and 14
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, body weight

Statistics:

Not reported

Results and discussion

Preliminary study:

No deaths or clinical signs of toxicity were observed in male or female rats. No treatment-related abnormalities were observed at necroscopy.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Remarks on result:

other: Based on lack of adverse clinical toxicity and mortality

Mortality:

There was no mortality observed in either male or female rats administered 1-dodecene, trimer, hydrogenated orally at 5000 mg/kg.

Clinical signs:

other: There were no signs of systemic toxicity observed at the 5000 mg/kg dose level.

Gross pathology:

Gross necroscopy revealed no remarkable findings in either male or female rats.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Acute oral LD50 >5000 mg/kg bw Criteria used for interpretation of results: EU

Conclusions:

Based on the lack of adverse systemic effects and mortality, the acute oral LD50 for 1-dodecene, trime, hydrogenatedr is >5000 mg/kg.

Executive summary:

In an acute oral toxicity study, 1 group of five fasted Sprague-Dawley rats/sex were given a single oral dose of 1 -dodecene, trimer (undiluted) at a dose of 5000 mg/kg bw and observed for 14 days. 

 

There was no mortality or clinical signs of toxicity observed. Body weight did not appear to be affected by treatment. There were no abnormalities observed at necropsy. Based on these results, the oral LD50 for 1 -dodecene, trimer is greater than 5000 mg/kg in rats.

 

This study received a Klimisch score of 1 and is classified as reliable without restrictions because the study was conducted according to OECD 401 guidelines and other guidelines and was GLP compliant.