Hydrocarbons, C4, 1,3-butadiene-free, polymd., tetraisobutylene fraction

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP guideline study. Deviation: 6 animals (3 males and 3 females) were used

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

yes

Remarks:

(6 animals (3 males and 3 females) were used)

GLP compliance:

no

Test type:

other: inhalation hazard test

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dodecene, branched

EC Number:

306-479-5

EC Name:

Dodecene, branched

Cas Number:

97280-83-6

IUPAC Name:

Dodecene, branched

Details on test material:

- Name of test material (as cited in study report): isododecene
- Analytical purity: 99%

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, Germany
- Age at study initiation: approximately 8-9 weeks
- Weight at study initiation: mean weight 283 g (males), 192 g (females)
- Housing: in groups of 3/sex in type D III wire mesh cages (without bedding)
- Diet: KLIBA 24-343-4 rat/mouse laboratory diet ad libitum except during exposure
- Water: ad libitum except during exposure
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20-24°C
- Humidity: 30-70%
- Air changes (per hr): no data
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

nose/head only

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus/atmosphere generation: the product was introduced to a height of 5 cm into a glass bottle (generator) with a sintered glass disk (pore-size 90-150 pm, diameter 30 mm) and the weight was determined. The generator containing the product was placed in a waterbath maintained at 20°C, and a stream of 200 L/hr compressed air was supplied to a downstream mixing chamber.
- Method of holding animals in test chamber: the air and test substance was passed through a glass distributor to 6 glass tubes in which the animals were held.
- After 30 minutes, the generator was replaced by a new one containing fresh test substance as described above. This generator was used for the remainder of the test.
- Temperature in air chamber: between 19-25°C

Analytical verification of test atmosphere concentrations:

yes

Remarks:

the amount of test substance used was determined by reweighing the generators. The nominal concentration was calculated from the amount of test substance consumed and the air volume.

Duration of exposure:

7 h

Concentrations:

3.8 mg/L (calculated)

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily check for mortality; clinical examinations were made each workday
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 3.8 mg/L air (nominal)

Exp. duration:

7 h

Remarks on result:

other: vapour

Mortality:

None

Clinical signs:

other: other:

Gross pathology:

No abnormalities

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of isododecene was greater than 3.8 mg/L.

Executive summary:

There was no mortality following head/nose-only 7 hr exposure to 3.8 mg isododecene/L (calculated) to 3 rats/sex.