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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across based on grouping of substances (category approach)
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:
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

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
This substance is very similar in structure 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 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
Remarks on result:
other: Equivalent to 2.1 mg/L.
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 (i.e., 2.1 mg/L) 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:

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.