Registration Dossier

Administrative data

Description of key information

For acute oral, dermal and inhalation toxicity studies, no mortality was observed at the highest doses tested, i. e. doses equal to or greater than 5000 mg/kg bw,

2000 mg/kg bw and 5000 mg/m3, respectively.

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:
read-across: supporting information
Qualifier:
equivalent or similar to
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 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
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
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1995/07/28-1995/09/08
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:
read-across: supporting information
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: Crl: CDBR
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Kingston Facility, Stone Ridge, New York
- Age at study initiation: Group 1, approximately 6-7 weeks; Group 2, approximately 8-9 weeks
- Weight at study initiation: Group 1 males, 182 to 208 grams; Group 1 females, 171 to 184 grams; Group 2 males, 315 to 339 grams; Group 2 females, 220 to 232 grams
- Fasting period before study: none
- Housing: Single housed during 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 was 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: At least 12 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 68-76 degrees F in animal room; 70-74 degrees F in exposure chamber
- Humidity (%): 40-70% relative humidity in animal room; 58-73% relative humidity in exposure chamber
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark


IN-LIFE DATES: From: 1995-08-08 To: 1995-09-08
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 material was generated using a single-barrel 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 3.5-4.0 psi back-pressure, producing a liquid droplet aerosol atmosphere within the 3-neck flask. The aerosol mixed with additional room air which was drawn through a glass mixing vessel prior to entering the exposure chamber.
- Method of particle size determination: The particle size distribution was determined once during each exposure using a Sierra Instruments Model 210 Cascade Impactor. Pre-weighed 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 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 (equivalent aerodynamic diameter), 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: Chamber airflow, temperature, and relative humidity were monitored continuously throughout the exposure and recorded approximately every 30 minutes.


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 pre-weighed teflon (PTFE) (Group 1) or glass fiber (Group 2) filters for non-volatile aerosol and a charcoal sorbent tube for volatile hydrocarbons.

From Group 1, the filters were first weighed for gravimetric determination of total non-volatile aerosol; the analytical procedure then specified analyis of both filters and sorbent tubes by GC/FID for total and individual hydrocarbons. However, the filters were not weighed until 8 days after the exposure and it appeared that a significant portion of the collected test material had volatilized from the fibers. Exposure was repeated with a second group of animals.

From Group 2, non-volatile aerosol was collected on a glass-fiber filter and the gravimetric determination was performed immediately following sample collection. The filters and sorbent tube were analyzed by GC/FID, and total hydrocarbons and individual hydrocarbons (full scan) were reported as the sum of the gravimetric aerosol and total hydrocarbon vapor results.

PARTICLE SIZE DATA
-Mass median equivalent aerodynamic diameter (50% size): Group 1 and Group 2, 3.7 microns
-Geometric standard deviation: Group 1, 2.9; Group 2, 2.5
-Percent <= 15 microns: Group 1, 91%; Group 2, 93.5%
-Percent <= 10 microns: Group 1, 83%; Group 2, 85.9%
-Percent <= 1 micron: Group 1, 10.6%, Group 2, 8.3%
Analytical verification of test atmosphere concentrations:
yes
Remarks:
gravimetrically (aerosol); GC/FID (vapor)
Duration of exposure:
4 h
Concentrations:
Group 1: estimated aerosol concentration of 5247 mg/m3
Group 2: analytical chamber concentration of 5266 mg/m3 (5213 mg/m3 aerosol, 53 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: At 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:
Statistical analyses included means and standard deviations of body weight and body weight change by group and sex.
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5 266 mg/m³ air (analytical)
Exp. duration:
4 h
Remarks on result:
other: No mortality occurred.
Mortality:
No mortality in either Group 1 or Group 2.
Clinical signs:
other: During exposure, animals in both Group 1 and Group 2 exhibited material on fur, decreased activity and closed eyes. Some animals in Group 2 displayed clear nasal discharge. Upon removal from chamber, animals in both groups displayed decreased activity, t
Body weight:
All animals displayed increased in body weight over their initial (Day 0) values, with the exception of two females in Group 2 that had slight weight losses.
Gross pathology:
All Group 1 animals were free of abnormalities at the gross postmortem evaluation.

In Group 2, 4 males/1 female exhibited red foci and/or slight discoloration on the lungs, 1 male displayed dark red nasal turbinates, 1 male had smaller than normal right kidney, and 3 males/1 female exhibited alopecia and/or scabs on the dorsal surface, extremities and/or head.
Interpretation of results:
other: Not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The LC50 for acute inhalation exposure (aerosol atmosphere) of MRD-95-247 is greater than 5266 mg/m3 (5213 mg/m3 aerosol, 53 mg/m3 vapor). This finding does not warrant classification of MRD-95-247 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 -247 was administered via individual whole-body inhalation chambers for four hours to two groups of ten Crl:CDBR rats at either an estimated aerosol concentration of 5247 mg/m3 or an analytical concentration of 5266 mg/m3 (5213 mg/m3 aersol, 53 mg/m3 vapor). Animals were observed for fourteen days following exposure. No mortality was observed, and all animals that received the estimated aerosol concentration of 5247 mg/m3 were free of gross pathological abnormalities. In the second group (5266 mg/m3 aerosol), 4 males and 1 female exhibited red foci on the lungs, one male displayed dark red nasal turbinates, and 3 males and 1 female had alopecia and/or scabs on the dorsal surface, extremities, and/or head. Based on the conditions of this study, the LC50 for acute inhalation exposure to an aerosol atmosphere of MRD-95 -247 is greater than 5266 mg/m3.

This finding does not warrant classification of MRD-95-247 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:
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:
read-across: supporting information
Qualifier:
equivalent or similar to
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 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: During exposure, observed abnormalities included wet/matted fur, decreased activity, and eyes closed. Upon removal from the chamber, all animals exhibited wet and matted fur. All animals recovered by the first day post-exposure, with the exception of one
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
Dose descriptor:
LC50
Value:
5 000 mg/m³

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:
read-across: supporting information
Qualifier:
equivalent or similar to
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 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
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Four studies were available for acute oral toxicity, dealing with the toxicity of C5-C20 normal paraffins, C14-C17, n-alkanes, C14-C16 paraffins and isohexadecane. All studies were conducted similarly to OECD guideline 401 without GLP compliance. All studies show no mortality at concentrations up to 5000 mg/kg bw.

Three studies were available for acute dermal toxicity, dealing with the toxicity of C5-C20 normal paraffins, C14-C17, n-alkanes and C14-C16 paraffins. All studies were conducted similarly to OECD guideline 402 without GLP compliance. All studies show no mortality at concentrations equal to or higher than 2000 mg/kg bw.

A reliable study and a non-reliable study were available for acute inhalation, dealing with the toxicity of Hydrocarbons, C10-C12, isoalkanes, <2% aromatics and C14-C16 n-paraffins, respectively. All studies were conducted similarly to OECD guideline 403. They all show no mortality at concentrations equal to or higher than 5000 mg/m3.

Justification for classification or non-classification

As all studies show LD50 > 5000 mg/kg, LD50 > 2000 mg/kg and LC50> 5000 mg/m3 by oral, dermal and inhalation routes, respectively. Substances in this category do not need to be classified for acute oral and dermal toxicity according to the criteria of Annex VI of Directive 67/548/EEC and CLP Regulation 1272/2008.