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Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
From 17th of November, 1980 to 1st of December, 1980
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
No GLP, no guideline claimed but test procedure in accordance with guideline but described in insufficient details (no concentration analysis, no granulometrical analysis, temperature not mentioned ...). Animals were whole-body exposed but cleaned at the end of exposure. Substance analytical certificate not available
Justification for type of information:
The justification for read across is provided as an attachment in IUCLID Section 13.
Cross-reference
Reason / purpose for cross-reference:
read-across: supporting information
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
From 17th of November, 1980 to 1st of December, 1980
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
No GLP, no guideline claimed but test procedure in accordance with guideline but described in insufficient details (no concentration analysis, no granulometrical analysis, temperature not mentioned ...). Animals were whole-body exposed but cleaned at the end of exposure. Substance analytical certificate not available
Justification for type of information:
The justification for read across is provided as an attachment in IUCLID Section 13.
Reason / purpose for cross-reference:
read-across source
Preliminary study:
Prior to test exposure, exploratory runs were made with the inhalation equipment to establish dose-setting relation of the test substance and the equipment.
Sex:
male/female
Dose descriptor:
LC50
Effect level:
>= 5.8 mg/L air (nominal)
Exp. duration:
4 h
Remarks on result:
other: plus a 29-min equilibration period
Mortality:
At the tested dose, no animal died during exposure nor during the 14 days observation period.
Clinical signs:
other: other:
Body weight:
See below table 7.2.2/3
Gross pathology:
See below table 7.2.2/3
Other findings:
No additional data

Table 7.2.2/2: Toxicological and pharmacological signs at 5.8 mg/L exposure level

Signs

Number of animals

Onset

Degree

Duration

Rales

2/10

On day 2 to 7

S1- Moderate

9 days or until termination

Thinness

2/10

On day 1 to 2

S1- Moderate

3 to 6 days

Table 7.2.2/3: Necropsy observation of animals sacrificed following the 14-day observation period

Animal no and sex

Organ

Findings

% change in body weight

1 M

-

All organs and tissues grossly not remarkable

+40.2

2 M

-

All organs and tissues grossly not remarkable

+24.4

3 M

-

All organs and tissues grossly not remarkable

+38.5

4 M

-

All organs and tissues grossly not remarkable

+25.2

5 M

Lungs

Slight congestion

Other organs and tissues grossly not remarkable

+30.7

6 F

Lungs

All organs and tissues grossly not remarkable

+3.1

7 F

-

All organs and tissues grossly not remarkable

+3.8

8 F

Fatty tissue (viscera)

Slight decrease

Other organs and tissues grossly not remarkable

+1.9

9 F

-

All organs and tissues grossly not remarkable

+5.7

10 F

-

All organs and tissues grossly not remarkable

+10.5

Interpretation of results:
other: Practically non toxic
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the test, C14-C16 n-Paraffins are not classified according to the criteria of Annex VI to the Directive 67/548/EEC and EU GHS.

Executive summary:

This data is being read across from the source study that tested C14 -C16 n-Paraffins based on analogue read across.

The toxicity of C14-C16 n-Paraffins was tested in COX-SD rats exposed by inhalation. Five males and five females were exposed to the test substance in the form of a mist at a delivery flow concentration of approximately 5.8 mg/L of air at a total flow rate of 9 L/min. The animals were observed for 2 weeks after treatment. At the end of observation period, they were killed and a pathology investigation was performed. No mortality occured during the study. Moderate rales were noted in 2 animals on day 2 to 7, that lasted 9 days or until termination. Moderate thinness was also recorded in 2 animals from day 1 or 2 and lasted 3 to 6 days.

Necropsy showed slight congestion of the lungs in 2 rats and a slight decrease of visceral fatty tissues in one animal.

As the acute LC50 by inhalation was found greater than 5.8 mg/L under the conditions of the test, C14-C16 n-Paraffins are not classified according to the criteria of Annex VI to Directive 67/548/EEC and EU GHS.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
Animals were whole-body exposed but cleaned at the end of exposure; no chamber concentration analysis, no granulometrical analysis
Principles of method if other than guideline:
Guideline principles
GLP compliance:
no
Remarks:
Not specified
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
C14-C16 n-Paraffins
IUPAC Name:
C14-C16 n-Paraffins
Details on test material:
- Name of test material (as cited in study report): C14-C16 n-Paraffins
- Substance type: Petroleum product, UVCB
- Analytical purity: 100% commercial product
- Composition of test material, percentage of components: C14-C16 n-paraffins
- Lot/batch No.: 8728K

Test animals

Species:
rat
Strain:
other: COX-SD
Sex:
male/female
Details on test animals or test system and environmental conditions:
No additional data

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
other: air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: DeVilbiss Nebulizer at delivery flow of 5.8 mg mist/L air
- Exposure chamber volume: 57 L
- Method of holding animals in test chamber: individually housed in metal, wire-bottomed cages elevated above the droppings.
- Source and rate of air: 9 L/min for 4-hour exposure period
- Method of conditioning air: no data
- System of generating particulates/aerosols: DeVilbiss Nebulizer
- Method of particle size determination: no data
- Treatment of exhaust air: no data
- Temperature, humidity, pressure in air chamber: no data

TEST ATMOSPHERE: no data

VEHICLE: no vehicle
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
4 h
Remarks on duration:
plus a 29-min equilibration period
Concentrations:
5.8 mg/L air
No. of animals per sex per dose:
5 rats/sex/dose (see Table 7.2.2/1)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at regular intervals during the first days and once daily thereafter for fourteen days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, after sacrifice: body weight,organ weights, organ examination, histopathology
Statistics:
No data

Results and discussion

Preliminary study:
Prior to test exposure, exploratory runs were made with the inhalation equipment to establish dose-setting relation of the test substance and the equipment.
Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
>= 5.8 mg/L air (nominal)
Exp. duration:
4 h
Remarks on result:
other: plus a 29-min equilibration period
Mortality:
At the tested dose, no animal died during exposure nor during the 14 days observation period.
Clinical signs:
other: other:
Body weight:
See below table 7.2.2/3
Gross pathology:
See below table 7.2.2/3
Other findings:
No additional data

Any other information on results incl. tables

Table 7.2.2/2: Toxicological and pharmacological signs at 5.8 mg/L exposure level

Signs

Number of animals

Onset

Degree

Duration

Rales

2/10

On day 2 to 7

S1- Moderate

9 days or until termination

Thinness

2/10

On day 1 to 2

S1- Moderate

3 to 6 days

Table 7.2.2/3: Necropsy observation of animals sacrificed following the 14-day observation period

Animal no and sex

Organ

Findings

% change in body weight

1 M

-

All organs and tissues grossly not remarkable

+40.2

2 M

-

All organs and tissues grossly not remarkable

+24.4

3 M

-

All organs and tissues grossly not remarkable

+38.5

4 M

-

All organs and tissues grossly not remarkable

+25.2

5 M

Lungs

Slight congestion

Other organs and tissues grossly not remarkable

+30.7

6 F

Lungs

All organs and tissues grossly not remarkable

+3.1

7 F

-

All organs and tissues grossly not remarkable

+3.8

8 F

Fatty tissue (viscera)

Slight decrease

Other organs and tissues grossly not remarkable

+1.9

9 F

-

All organs and tissues grossly not remarkable

+5.7

10 F

-

All organs and tissues grossly not remarkable

+10.5

Applicant's summary and conclusion

Interpretation of results:
other: Practically non toxic
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the test, C14-C16 n-Paraffins are not classified according to the criteria of Annex VI to the Directive 67/548/EEC and EU GHS.

Executive summary:

The toxicity of C14-C16 n-Paraffins was tested in COX-SD rats exposed by inhalation. Five males and five females were exposed to the test substance in the form of a mist at a delivery flow concentration of approximately 5.8 mg/L of air at a total flow rate of 9 L/min. The animals were observed for 2 weeks after treatment. At the end of observation period, they were killed and a pathology investigation was performed. No mortality occured during the study. Moderate rales were noted in 2 animals on day 2 to 7, that lasted 9 days or until termination. Moderate thinness was also recorded in 2 animals from day 1 or 2 and lasted 3 to 6 days.

Necropsy showed slight congestion of the lungs in 2 rats and a slight decrease of visceral fatty tissues in one animal.

As the acute LC50 by inhalation was found greater than 5.8 mg/L under the conditions of the test, C14-C16 n-Paraffins are not classified according to the criteria of Annex VI to Directive 67/548/EEC and EU GHS.