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EC number: 940-730-5 | CAS number: -
Acute Toxicity: inhalation
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: see below Table 7.2.2/2
- Body weight:
- See below table 7.2.2/3
- Gross pathology:
- See below table 7.2.2/3
- Other findings:
- No additional data
- 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.
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 |
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- 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
- 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
Constituent 1
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: see below Table 7.2.2/2
- 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.
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