Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Oral LD50 (rat) > 5000 mg/Kg bw

Inhalation LC50 (rat) >5991 mg/m³

Dermal LD50 (rabbit) > 3160 mg/Kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From the 14th to the 28th of June 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
No guideline claimed but test procedure in accordance with guideline and described in sufficient details. Substance analytical certificate not available. Test substance information available from the manufacturer for code name (C14-C17 normal Paraffins)
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: supporting information
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Guideline principles
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Taconic Farms, Germantown, New York
- Age at study initiation: 10-11 weeks of age
- Weight at study initiation: 189 to 317 grams
- Fasting period before study: overnight
- Housing: suspended stainless steel
- Diet (e.g. ad libitum): Purina rodent chow ad libitum
- Water (e.g. ad libitum): yes
- Acclimation period: 21 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24
- Humidity (%): 40 to 70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 14 June 1983 To: 28 June 1983
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
No additional data
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 rats/sex/dose (see Table 7.2.1/1)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 2, 4, 6 hours after dosing and once per day thereafter, body weights: prior to dosing and at day 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
Statistics:
no data
Preliminary study:
no additional data
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortality was observed during the study
Clinical signs:
There were few clinical in-life observations during the test period.
A/G staining was observed in 5 males and 4 females animals at the 4 hour observation and in 5 males and 5 females at the 6 hours observation.
Unthrifty coat was observed in 2 males and 4 females on the day 1 observation.
Alopecia was observed on day 10, 11, 12, 13 on one female.
Body weight:
No effect was observed on body weight gain for all animals.
Gross pathology:
The only gross post mortem observation noted at necropsy was lung discoloration in 7 of the 10 test animals.
Other findings:
No additional data

No additional data

Interpretation of results:
other: Practically non toxic
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, MRD-83-207 is not classified according to the criteria of Annex VI to the Directive 67/548/EEC and CLP Regulation 1272/2008.
Executive summary:

MRD-83-207 was tested for acute oral toxicity in Sprague-Dawley rats in a limit dose assay.
The test substance, a liquid, was administered as supplied. Animals were fasted overnight prior to treatment. The assay was conducted on a group of 10 rats (5 males, 5 females) with a dose of 5000 mg/kg b.w. administered by gavage (via a syringe) in a single oral dose.


Examinations for mortality, clinical signs and body weight gain were performed during the 14-day observation period. All surviving animals were necropsied at the end of the observation period.

No deaths occurred during the study. Body weight gain was not affected by treatment. A/G staining was noted in all animals within the 6-hour observation period. In-life observations also included alopecia and unkempt coat. At necropsy, macroscopic examination of main organs showed lung discoloration in seven animals.

As the acute oral LD50 was found to be greater than 5000 mg/kg b.w. under the conditions of the test, MRD-83-207 is not classified according to the criteria of Annex VI to Directive 67/548/EEC and CLP Regulation 1272/2008.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
One key read across study available from structural analogues.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1995-09-20 to 1995-10-05
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to or similar to guideline study OECD 403: GLP
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: supporting information
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories Inc., Kingston, New York USA
- Age at study initiation: Males, approximately 6 weeks; Females, approximately 7 weeks
- Weight at study initiation: Males, 155 to 168 grams; Females, 157 to 177 grams
- Fasting period before study: none
- Housing: Single housed during the study period. Suspended stainless steel and wire mesh.
- Diet (e.g. ad libitum): Certified Rodent Diet #5002, from PMI Feeds, Inc., Richmond, Indiana, ad libitum, during non-exposure periods. Food withheld while animals were in chamber.
- Water (e.g. ad libitum): Automatic watering system, ad libitum, during non-exposure periods. Water withheld while animals were in chamber.
- Acclimation period: 8 days.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 68-76 degrees F while in animal room; 71-74 degrees F while in exposure chamber
- Humidity (%): 40-70% relative humidity while in animal room; 82-95% relative humidity while in exposure chamber
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark


IN-LIFE DATES: From: 1995-09-21 To: 1995-10-05
Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: 150 liter stainless steel and acrylic whole-body inhalation exposure chamber.
- System of generating particulates/aerosols: The test atmosphere was generated using a Laskin nebulizer and a 3-neck round-bottom flask as a reservoir for the liquid test material. Compressed air was supplied to the nebulizer at approximately 4-5 psi back-pressure, producing a liquid droplet aerosol within the 3-neck flask. The aerosol was mixed with additional room air and then drawn into the exposure chamber.
- Method of particle size determination: Sierra Instruments Model 210 Cascade Impactor. Preweighed glass fiber filters were used to collect the aerosol on each stage. A bulk estimation technique was employed to characterize the particle size distribution of the test atmosphere. The change in weight of the filter for each stage was measured and the cumulative percent of the sample collected on each stage was calculated. This information plus the stage constants for the impactor were used to calculate the 15.9%, 50.0% and 84.1% particle sizes, the geometric standard deviation, and the estimated percent of the aerosol less than or equal to 1, 10, and 15 microns in size.
- Temperature, humidity, pressure in air chamber:

TEST ATMOSPHERE
- Brief description of analytical method used: Analytical chamber concentrations were determined during each hour of the exposure by drawing a known volume of the test atmosphere through a sample train consisting of a glass-fiber filter for collection of non-volatile aerosol and a charcoal sorbent tube for collection of volatile hydrocarbons (vapor).

Non-volatile aerosol concentrations were first determined gravimetrically by dividing filter weight gain by the sample volume. The filters and the charcoal tubes were then analyzed by GC/FID. Total hydrocarbons and individual hydrocarbons (full scan) were reported for both sample types. Total analytical chamber concentrations were reported as the sum of the gravimetric aerosol and total hydrocarbon vapor results.

PARTICLE SIZA DATA
-Mass median equivalent aerodynamic diameter (50% size): 3.4 microns
-Gravimetric standard deviation: 2.1
-Percent <= 15 microns: 98.0%
-Percent <= 10 microns: 93.3%
-Percent <= 1 micron: 4.6%

Analytical verification of test atmosphere concentrations:
yes
Remarks:
Gravimetrically (aerosol); GC/FID (vapor)
Duration of exposure:
4 h
Concentrations:
5991 mg/m3 (5428 mg/m3 aerosol, 562 mg/m3 vapor)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Approximately 15 minute intervals during the first hour of exposure and once each hour thereafter through the termination of exposure.
- Necropsy of survivors performed: yes
Statistics:
Means and standard deviations for body weight and body weight change by group and sex
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5 991 mg/m³ air (analytical)
Exp. duration:
4 h
Remarks on result:
other: No mortalities.
Mortality:
No mortalities occurred.
Clinical signs:
other: other:
Body weight:
All animals displayed increases in body weight over their initial (Day 0) values.
Gross pathology:
All ten animals were free of internal macroscopic abnormalities at post-mortem examination.
Interpretation of results:
other: Not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The LC50 for acute inhalation exposure (aerosol atmosphere) to MRD-95-289 is greater than 5991 mg/m3 (5428 mg/m3 aerosol, 562 mg/m3 vapor). This finding does not warrant classification of Isopar M as an acute inhalation toxicant under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

To assess acute inhalation toxicity, MRD-95 -289 was administered via individual whole-body inhalation chambers for four hours to ten Crl:CDBR rats at a total chamber concentration of 5991 mg/m3 (5428 mg/m3 aerosol, 562 mg/m3 vapor). Animals were observed for fourteen days following exposure. There were no mortality or gross pathological alterations in the animals, with the exception of two animals that displayed scabs and one with a necrotic and truncated tail. Based on the conditions of the study, the LC50 for acute inhalation exposure to an aerosol atmosphere of MRD-95 -289 is greater than 5991 mg/m3.

This finding does not warrant classification of MRD-95 -289 as an acute inhalation toxicant under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
5 991 mg/m³
Quality of whole database:
One weight of evidence study available from structural analogues.

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 28th of june to 12th of July, 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
No guideline claimed but test procedure in accordance with guideline and described in sufficient detail. Substance analytical certificate not available. Substance identification: information available from supplier for code name (C14-C17 normal Paraffins)
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: supporting information
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Principles of method if other than guideline:
Guideline principles
GLP compliance:
no
Remarks:
Not specified
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hazleton Dutchland, Inc., Denver, PA
- Age at study initiation: approximately 14 weeks
- Weight at study initiation: 2.37 to 2.74 kg
- Housing: individually in suspended stainless steel cages without bedding.
- Diet: Purina Rabbit Chow HF (pellets) ad libitum.
- Water: Automatic watering system ad libitum. Analyzed monthly.
- Acclimation period: 22 days (including quarantine)


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-21°C (65-71°F). Monitored twice daily.
- Humidity (%): 40-70%. Monitored once daily.
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 by automatic timer.

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal surface from the shoulder region to the lumbar region
- Type of wrap if used: gauze patch secured to the trunk of animal with tape and plastic sleeve.

REMOVAL OF TEST SUBSTANCE
No washing, skin was wiped.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 9.6 to 11.2 mls


Duration of exposure:
24 hours
Doses:
3160 mg/kg b.w.
No. of animals per sex per dose:
3 animals/sex/dose (see Table 7.2.3/1)
Control animals:
not required
Details on study design:
SCORING SYSTEM: Draize scale
- Duration of observation period following administration: 14 days
- Frequency of observations:
* Viability: twice a day
* Clinical observations (nature, onset and duration of toxicological signs): 2 and 4 hours after dosing and once per day thereafter
* Dermal responses: 24 hours post-dosing (after patch removal), and on Days 3, 7, 10 and 14 according to the Draize method of scoring)
* Body weights: Days 0, 7 and 14
- Necropsy of survivors performed: yes (after intravenous administration of sodium phenobarbitol)
Statistics:
The means and standard deviations for the body weights were calculated.
Preliminary study:
Not applicable
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 160 mg/kg bw
Mortality:
No deaths occurred during the study
Clinical signs:
1 animal was noted with nasal discharge on day 8. No other abnormalities was observed.
Body weight:
1 male and 3 females gained weight during the 14-day test period. See Table 7.2.3/2 for details
Gross pathology:
No lesions observed on gross postmortem examinations that are considered to be treatment-related. 4 of the 6 animals revealed no observable abnormalities. See Table 7.2.3/3 for details.
Other findings:
- Other observations:
Dermal observations: test material produced moderate to severe dermal irritation in all test animals at the 24-hour observation. This irritation regressed as the study progressed and on Day 14 only 2 animals had very slight irritation. Desquamation was the only supplemental dermal observation noted in several animals during the test period.
See Table 7.2.3/4 for details.

Table 7.2.3/2: Individual animal weights (kg):

Day 0

Day 7

Day 14

JEA561M

2.58

2.39

2.58

JEA567M

2.51

2.44

2.46

JEA569M

2.74

2.78

2.88

Mean

2.61

2.54

2.64

Standard deviation

0.12

0.21

0.22

JEA572F

2.37

2.39

2.42

JEA566F

2.59

2.56

2.65

JEA574F

2.70

2.88

2.99

Mean

2.55

2.61

2.69

Standard deviation

0.17

0.25

0.29

Table 7.2.3/3: Necropsy observation

JEA561M

STOMACH : contains slight amount of hair with ingesta

JEA567M

KIDNEYS (both) : medulla slightly reddened

STOMACH : slight amount of hair present with ingesta

JEA569M

No observable abnormalities

JEA572F

No observable abnormalities

JEA566F

No observable abnormalities

JEA574F

No observable abnormalities

Table 7.2.3/4: Irritant/corrosive response data for each animal at each observation time:

Score at time point

Erythema

Oedema

Max. score: 4

Max. score: 4

M

F

M

F

24 hours

3/2/3

2/2/2

1/0/0

0/0/0

Day 3

2/1/2

1/2/1

1/0/0

0/0/0

Day 7

2/1/1

0/1/1

0/0/0

0/0/0

Day 10

1/0/1

0/1/1

0/0/0

0/0/0

Day 14

0/0/0

0/1/1

0/0/0

0/0/0

Interpretation of results:
other: Practically nontoxic
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
MRD83-207 is not classified according to the criteria of Annex VI to the Directive 67/548/EEC and CLP Regulation 1272/2008.
Executive summary:

MRD-83 -207 was tested for acute dermal toxicity in New Zealand rabbits in a limit dose assay similar to OECD guideline N°402. The test substance, a liquid, was administered undiluted. Hair was removed from to the backs of animals with clippers. The assay was conducted on a group of 6 rabbits (3 males, 3 females) with a dose of 3160 mg/kg b.w. administered in a single dermal dose. The test substance was applied for 24 hours under an occlusive patch. Skin was wiped at the end of the 24-hour exposure period to remove remaining test substance.


Examinations for mortality, clinical signs and body weight gain were performed during the 14 -day observation period. All surviving animals were necropsied at the end of the observation period.
No deaths and clinical signs occurred during the observation period.

Body weight gain was not affected by treatment. At necropsy, macroscopic examination of main organs showed no abnormalities.

Irritation signs were recorded up to Day 14. Moderate to severe erythema was observed in all rabbits at the end of exposure while very slight edema was only observed in one animal. Then, no edema was observed in any rabbits. Very slight erythema was still observed in 4 animals by day 10. At the end of observation period (day 14), very slight erythema was still recorded in two females.

As the acute dermal LD50 was greater than 3160 mg/kg b.w. under the conditions of the test, MRD-83-207 is not classified according to the criteria of Annex VI to Directive 67/548/EEC and CLP Regulation 1272/2008.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
3 160 mg/kg bw
Quality of whole database:
One key read across study available from structural analogues.

Additional information

There are no acute oral, inhalation, or dermal toxicity data available for Hydrocarbons, C15-C19, n-alkanes, isoalkanes, <2% aromatics. However, data are available for structural analogues, Hydrocarbons, C12-C16, isoalkanes, cyclics, <2% aromatics; C14-C16, n-Paraffins, Hydrocarbons, C14-C17, n-alkanes, <2% aromatics; isohexadecane, and C5-C20 normal paraffins. These data are read across to Hydrocarbons, C15-C19, n-alkanes, isoalkanes, <2% aromatics based on analogue read across and a discussion and report on the read across strategy is provided as an attachment in IUCLID Section 13.

Oral

Paraffin (petroleum), normal, C5-C20

Paraffin (petroleum), normal, C5-C20 was tested for acute oral toxicity in Sprague-Dawley rats in a limit dose assay (ExxonMobil, 1983). The test substance, a liquid, was administered as supplied. Animals were fasted overnight prior to treatment. The assay was conducted on a group of 10 rats (5 males, 5 females) with a dose of 5000 mg/Kg b.w. administered by gavage (via a syringe) in a single oral dose. Examinations for mortality, clinical signs and body weight gain were performed during the 14-day observation period. All surviving animals were necropsied at the end of the observation period. No deaths occurred during the study. Body weight gain was not affected by treatment. A/G staining was noted in all animals within the 6-hour observation period. In-life observations also included alopecia and unkempt coat. At necropsy, macroscopic examination of main organs showed lung discoloration in seven animals. As the acute oral LD50 was found to be greater than 5000 mg/Kg b.w. under the conditions of the test, the test material is not classified according to the criteria of CLP Regulation 1272/2008.

C14-C16 n-Paraffins

In a supporting toxicity study (Conoco, Inc., 1982), C14-C16 n-Paraffins was tested for acute oral toxicity in COX-SD rats in an acute dose assay. Animals were fasted overnight prior to treatment. The test substance, a liquid, was administered as supplied. The assay was conducted on a group of 10 rats (5 males, 5 females) with doses of 4750 mg/Kg b.w. or 5250 mg/Kg b.w. administered by gavage in a single oral dose. Examinations for mortality, clinical signs and body weight gain were performed during the 14-day observation period. All surviving animals were necropsied at the end of the observation period. One male died at the lowest test substance dose while no mortality was observed at the highest dose. Hypoactivity of the animals was observed within 24 hours post-treatment but not after. Diarrhea, diuresis, wet skin and fur of anogenital region and general weakness were also noted at both doses within one to three days post-treatment. Body weight gain was not affected by treatment. At necropsy, macroscopic examination of main organs showed no abnormalities. As the acute oral LD50was found greater than 5250 mg/Kg b.w. under the conditions of the test, C14-C16 n-Paraffins are not classified according to the criteria of CLP Regulation 1272/2008.

Hydrocarbons, C14-C17, n-alkanes, <2% aromatics

In a supporting study (Cepsa, 1984), the test material (Hydrocarbons, C14-C17, n-alkanes, <2% aromatics) was tested for acute oral toxicity in HC/CFY rats in a limit dose assay. The assay was conducted on a group of 10 rats (5 males, 5 females) with a dose of 5000 mg/Kg b.w. administered by gavage, as supplied, in a single oral dose (maximum dose volume of 6.4 mL/Kg b.w). Examinations for mortality, clinical signs and body weight gain were performed during the 14-day observation period. All surviving animals were necropsied at the end of the observation period. No deaths occurred. Pilo-erection was observed in all animals shortly after dosing but not at 72-hour observation period. Body weight gain was not affected by treatment. At necropsy, macroscopic examination of main organs showed no abnormalities. As the acute oral LD50was found greater than 5000 mg/Kg b.w. under the conditions of the test, the test material was not classified according to the criteria of CLP Regulation 1272/2008.

 

Isohexadecane

In a supporting study (INEOS, 1980), the toxicity of isohexadecane in Sprague-Dawley rats was tested by gavage of the undiluted liquid test substance as supplied. The animals were observed for 4 weeks after treatment. At the end of observation period, they were killed and a necropsy was performed. The test doses were 2.15, 4.64, 10.0, 21.15, 31.6 and 46.4 mL/Kg bw. Five males and five females were tested at the three lower doses while 10 rats of both sexes were treated at the three higher dose groups. No mortality was observed at any tested dose. Sublethal effects were noted such as oily secretion in the area of anus for tested dose from 4.64 mL/kg bw to 46.4 mL/kg bw. Moreover, 28% and 11% daily food intake decrease was recorded in females treated at 31.6 mL/kg bw on the first and the second day of observation, respectively. The same effects (32% and 49% food intake decreases) were observed at the 24 and 48-hour observation periods in females treated with the highest dose. Decrease of body weight intake was also observed on first observation day in treated females at 46.4 mL/kg bw, corresponding to 37 g/kg bw. No LD50 was determined.

Inhalation

Hydrocarbons, C12-C16, isoalkanes, cyclics, < 2% aromatics

In a key study (ExxonMobil, 1997), to assess acute inhalation toxicity, the test material (Hydrocarbons, C12-C16, isoalkanes, cyclics, < 2% aromatics) was administered via individual whole-body inhalation chambers for four hours to ten Crl:CDBR rats at a total chamber concentration of 5991 mg/m3 (5428 mg/m3 aerosol, 562 mg/m3vapor). Animals were observed for fourteen days following exposure. There were no mortality or gross pathological alterations in the animals, with the exception of two animals that displayed scabs and one with a necrotic and truncated tail. Based on the conditions of the study, the LC50 for acute inhalation exposure to an aerosol atmosphere of the test material was greater than 5991 mg/m3. This finding does not warrant classification of MRD-95 -289 as an acute inhalation toxicant under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).

C14-C16 n-Paraffins

In a supporting study (Conoco, Inc., 1982), 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 to be greater than 5.8 mg/L under the conditions of the test, C14-C16 n-Paraffins are not classified according to the criteria of EU GHS.

Dermal

Paraffin (petroleum), normal, C5-C20

Paraffin (petroleum), normal, C5-C20 was tested for acute dermal toxicity in New Zealand rabbits in a limit dose assay similar to OECD guideline 402 (ExxonMobil, 1983). The test substance, a liquid, was administered undiluted. Hair was removed from to the backs of animals with clippers. The assay was conducted on a group of 6 rabbits (3 males, 3 females) with a dose of 3160 mg/Kg b.w. administered in a single dermal dose. The test substance was applied for 24 hours under an occlusive patch. Skin was wiped at the end of the 24-hour exposure period to remove remaining test substance. Examinations for mortality, clinical signs and body weight gain were performed during the 14 -day observation period. All surviving animals were necropsied at the end of the observation period. No deaths and clinical signs occurred during the observation period. Body weight gain was not affected by treatment. At necropsy, macroscopic examination of main organs showed no abnormalities. Irritation signs were recorded up to Day 14. Moderate to severe erythema was observed in all rabbits at the end of exposure while very slight edema was only observed in one animal. Then, no edema was observed in any rabbits. Very slight erythema was still observed in 4 animals by day 10. At the end of observation period (day 14), very slight erythema was still recorded in two females. As the acute dermal LD50was greater than 3160 mg/Kg b.w. under the conditions of the test, the test material is not classified according to the criteria of CLP Regulation 1272/2008.

C14 -C16 n-paraffins

In a supporting study (Conoco, Inc., 1982), the acute dermal toxicity of C14 -C16 n-paraffins was determined in male and female adults New Zealand White rabbits. The test substance was applied at 500 or 2000 mg/Kg b.w. concentration on abraded skin of rabbits exposed for 24 hours by an occlusive dressing. At the end of exposure, the remaining test substance was wiped by means of absorbent paper. Examinations for mortality, clinical signs and body weight gain were performed during the 14-day observation period. All surviving animals were necropsied at the end of the observation period. No deaths nor clinical signs occurred during the observation period. Body weight gain was not affected by treatment.

At the 24 hour observation interval, all of the animals showed very slight to marked erythema and edema of the skin at the treatment site. The initial dermal reaction was followed by thickening and/or wrinkling, fissuring, dryness and desquamation of which residual effects persisted in each through termination of the study. As the acute dermal LD50 was greater than 2000 mg/Kg b.w. under the test conditions, C14 -C16 n-paraffins are not classified according to the criteria of CLP Regulation 1272/2008.

Hydrocarbons, C14-C17, n-alkanes, <2% aromatics

In a supporting study (Petroquimica, 1984), the test material (Hydrocarbons, C14-C17, n-alkanes, <2% aromatics) was tested for acute dermal toxicity in HC/CFY (remote Sprague-Dawley) rats in a limit dose assay according to OECD guideline 402. The test substance, a liquid, was administered undiluted as supplied. A 10% total body surface of hair was removed from the dorso-lumbar region with clippers in every animal. The assay was conducted on a group of 10 rats (5 males, 5 females) with a dose of 2000 mg/Kg b.w. administered by spreading in a single dermal dose (maximum dose volume of 2.6 mL/Kg b.w). After test substance application an occlusive patch was held in place for 24 hours. Skin was washed with water at the end of the 24-hour exposure period. Examinations for mortality, clinical signs and body weight gain were performed during the 14-day observation period. All surviving animals were necropsied at the end of the observation period. No deaths and clinical signs occurred during the observation period. Body weight gain was not affected by treatment. At necropsy, macroscopic examination of main organs showed no abnormalities.

Slight to well-defined and slight oedema was observed at the site of treatment in all animals. Reversibility was generally observed by day 6 with the exception of one animal showing slight oedema until Day 9. All rats developed small, slightly raised erythematous areas at the dose site on the day 6. Then, small focal scab formations persisted from day 9 to day 15 in all rats except two females which had recovered by day 14. Two small areas of necrosis were observed at the treatment site on two males on day 2 but not on day 6 and day 9, respectively. As the acute dermal LD50 was greater than 2000 mg/Kg b.w. under the test conditions, the test material is not classified according to the criteria of CLP Regulation 1272/2008.

Justification for classification or non-classification

Based on available read across-data, Hydrocarbons, C15-C19, n-alkanes, isoalkanes, <2% aromatics is minimally toxic via ingestion where the LD50 is >5000 mg/Kg, via dermal exposure where the LD50 is >3160 mg/Kg, and by inhalation where the LC50 >5991 mg/m3. These findings do not warrant classification according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP).

Hydrocarbons, C15-C19, n-alkanes, isoalkanes, <2% aromatics is classified according to the EU CLP Regulation as a Category 1 aspiration hazard based on its physical and chemical properties (hydrocarbon fluid, viscosity ≤ 20.5 mm2/s).