Dodecene

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable with restrictions because while there is no statement regarding whether this study was conducted according to GLP or equivalent, the study appears to closely adhere to OECD Guideline 403.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

yes

Remarks:

Only limited details were provided.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Alkenes, C10/C11/C12/C13

IUPAC Name:

Alkenes, C10/C11/C12/C13

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): Olefins 103 PQ 11
- Substance type: C10-C13 isomerised olefins
- Analytical purity: Not reported

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Shell Toxicology Laboratory Breeding Unit
- Age at study initiation: 10 weeks old
- Weight at study initiation: Not reported
- Housing: Individually, except during exposure when they were housed in groups of 5.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Approximately 20°C
- Humidity (%): Approximately 55%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Glass chamber
- Exposure chamber volume: Seven litres
- Method of holding animals in test chamber: Not reported
- Source and rate of air: Air was passed at a minimal rate of 10 litres per minute.
- Method of conditioning air: Not reported
- System of generating particulates/aerosols: Flash vaporization of the test substance supplied to a heated flask via a micro metering pump. The vapour was blended with dilution air in a mixing flask, and the vapour/air mixture was passed through an air cooled condenser and a catch pot to retain any condensed liquid, to the inhalation chambers.
- Temperature, humidity, pressure in air chamber: Not reported

TEST ATMOSPHERE
- Brief description of analytical method used: Heated total hydrocarbon analyser calibrated with standard atmospheres of the test substance prepared in Tedlar gas sampling bags.
- Samples taken from breathing zone: No data

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

2.1 mg/L

No. of animals per sex per dose:

5 animals per sex

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observation frequency was not reported. Animals were weighed at study initiation, 7 and 14 days.
- Necropsy of survivors performed: no
- Other examinations performed: Clinical signs, body weight

Statistics:

No information reported.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 2 100 mg/m³ air

Exp. duration:

4 h

Mortality:

None

Clinical signs:

other: Lachrymation and salivation during exposure in some rats, but these signs did not persist during the observation period.

Body weight:

Body weight data was not provided.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information LC50 is greater than the saturation concentration of 2100 mg/m3. Criteria used for interpretation of results: EU

Conclusions:

The LC50 is greater than 2100 mg/m3, which is the saturation concentration for the test compound.

Executive summary:

Justification for Read Across

Several criteria justify the use of the read across approach to fill data gaps forisomerised olefins; alpha, internal, linear and branched - single carbon numbersubstances usingisomerised olefins; alpha, internal, linear and branched – multiple carbon numbersubstance analogues. Studies indicate that changing the carbon number or the location of the double bond, or adding branching does not measurably alter the mammalian health endpoints. Toxicity concerns are low for acute exposure to multiple carbon number isomerised olefin substances. Genotoxicity studies indicate that these materials are not mutagenic. There was no adverse systemic toxicity observed in a 90-day repeated oral dose study, in which rats were exposed to alkenes, C20-24. As a result, all of the above tested mammalian toxicity endpoints indicate a low hazard potential for human health. There do not appear to be any toxicological differences between multiple carbon number isomerised olefins and single carbon number isomerised olefins.  Therefore, read across between these two categories can be justified.

 

The acute inhalation toxicity of Olefin 103 PQ 11 (2.1 mg/L, exact blend unknown) was measured in male and female rats (5 per sex) after a 4-hour exposure. The LC₅₀was calculated based on mortality of the rats; no other statistical methods were used. Exposure to the test material did not result in any mortality. Toxic effects included lachrymation and salivation during exposure in some rats, but these signs did not persist during the observation period. The acute inhalation LC₅₀for Olefin 103 PQ 11 was reported as > 2100 mg/m3. 

 

This study received a Klimisch score of 1 and is classified as reliable with restrictions because while there is no statement regarding whether this study was conducted according to GLP or equivalent, the study appears to closely adhere to OECD Guideline 403. This study will influence the DNEL(s).