Stoddard solvent

Endpoint summary

Description of key information

Acute oral toxicity:

The LD50 value of >5000 mg/kg for Stoddard Solvent was determined in a rat study.

In an acute oral toxicity study, groups of fasted, young adult, Sprague Dawley rats, five male and five female, were given a single oral dose of undiluted Stoddard solvent at a dose of 5000 mg/kg bw and observed for 14 days.

There were no treatment related mortalities. All of the study animals exhibited one or more of the following clinical signs: nasal discharge, ocular discharge, abnormal stools, lethargy, stained coat, and alopecia. All animals gained weight during study period. At necropsy, one of the ten animals exhibited visual lesions, the remaining nine showed signs of alopecia in the inguinal and/or perineal regions. The oral LD50 was determined to be greater than 5000 mg/kg in males and females

 

Acute dermal toxicity:

 

The LD50 for Stoddard solvent is >3000 mg/kg. Based on these findings, Stoddard solvent does not warrant classification as an acute dermal 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.

 

Acute inhalation toxicity:

 The 4 hour rat inhalational LC50 for Stoddard solvent is >5.5 mg/L (5500 mg/m3) .No deaths, languid behavior and squinted eyes; 3/5 females exhibited no weight gain during 8 day observation. Based on zero mortality and absence of significant toxicity, body weight observations, and gross post-mortem and histopathological results, in the lungs, it is concluded that Stoddard solvent does not have acute toxic effects under the conditions of this study.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Single dose

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

Published data in readily available literature.Reliability score 2 on the basis of the weight of evidence found during review of public documents existing relating to toxicological data

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

10 rats male/female test substance was administered to 10 rats male/female in undiluted form MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg bw

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Specific details on test material used for the study:

C9-C13 Mixed aliphatics and aromatics (8052-41-3)

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: Bantin & Kingman, Fremont, CA- Age at study initiation: young adults (eight to twelve weeks old)
- Weight at study initiation: approximately 200 to 350 grams pre-fasting- Fasting period before study: animals were not fed the night before dosing
- Housing: individually housed in stainless steel, wire mesh bottom cages
- Diet: fresh certified Agway rodent feed provided ad libitum, feed was withheld the night before dosing
- Water: fresh potable water was provided ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS- Temperature (°C): 17 to 26 degrees Celsius, within protocol limits
- Humidity (%): 40 to 70%, within protocol limits
- Air changes (per hr): no less than ten air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

No vehicle, test substance was administered in undiluted form MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 male and 5 female

Control animals:

yes

Details on study design:

- Duration of observation period following administration: fourteen days
- Frequency of observations and weighing: animals were observed hourly for first four hours after dosing and twice daily for the following fourteen days; animals were weighed when acquired by the testing facility, prior to fasting, prior to test administration, and on days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, external evaluation at necropsy

Statistics:

The mean and standard deviation for body weight data were calculated

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Based on lack of mortality and systemic effects

Mortality:

No animals died during the testing period

Clinical signs:

other: All of the study animals exhibited one or more of the following clinical signs: nasal discharge, ocular discharge, abnormal stools, lethargy, stained coat, and alopecia.

Gross pathology:

At necropsy, one of the ten animals exhibited visual lesions, the remaining nine showed signs of alopecia in the inguinal and/or perineal regions.

Interpretation of results:

other: not classified

Conclusions:

The LD50 value of >5000 mg/kg for Stoddard Solvent was determined in a rat study.
In an acute oral toxicity study, groups of fasted, young adult, Sprague Dawley rats, five male and five female, were given a single oral dose of undiluted Stoddard solvent at a dose of 5000 mg/kg bw and observed for 14 days.
There were no treatment related mortalities. All of the study animals exhibited one or more of the following clinical signs: nasal discharge, ocular discharge, abnormal stools, lethargy, stained coat, and alopecia. All animals gained weight during study period. At necropsy, one of the ten animals exhibited visual lesions, the remaining nine showed signs of alopecia in the inguinal and/or perineal regions. The oral LD50 was determined to be greater than 5000 mg/kg in males and females

Executive summary:

The LD50 value of >5000 mg/kg was determined in a rat study. In an acute oral toxicity study, groups of fasted, young adult, Sprague Dawley rats, five male and five female, were given a single oral dose of undiluted Stoddard solvent at a dose of 5000 mg/kg bw and observed for 14 days. There were no treatment related mortalities. All of the study animals exhibited one or more of the following clinical signs: nasal discharge, ocular discharge, abnormal stools, lethargy, stained coat, and alopecia. All animals gained weight during study period. At necropsy, one of the ten animals exhibited visual lesions, the remaining nine showed signs of alopecia in the inguinal and/or perineal regions. The oral LD50 was determined to be greater than 5000 mg/kg in males and females

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Single dose

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

Published data in readily available literature.Reliability score 2 on the basis of the weight of evidence found during review of public documents existing relating to toxicological data

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Specific details on test material used for the study:

C9-C12 Mixed aliphatics and aromatics (8052-41-3) Boiling Point Range 160-199 °C

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The animals were dosed at a level of 5000 mg/kg. Each rat was dosed by drawing the specified volume into a 3cc syringe and orally intubating the restrained animal with a stainless steel gavage needle and introducing the test article into the stomach.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 male and 5 female

Control animals:

yes

Details on study design:

Within 24 hours before dosing, each animal was weighed and observed for general health. The rats were randomly assigned to the test using a computer randomization program. All rats were fasted for approximately 16 hours before dosing.The animals were dosed at a level of 5000 mg/kg. Each rat was dosed by drawing the specified volume into a 3cc syringe and orally intubating the restrained animal with a stainless steel gavage needle and introducing the test article into the stomach.Each animal was observed for the following: no observable abnormalities, oral discharge, nasal discharge, respiration, tremors, incoordination, recumbancy, and stools. The categories were on a 1 to 3 scoring scheme (slight, moderate, severe).All animals were observed hourly for the first four hours the day of dosing and twice a day during the 14 -day observation period. All animals at the conclusion of the study were subjected to a gross necropsy.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Based on lack of mortality and systemic effects

Mortality:

No mortality among the test subjects was seen during the course of the study.

Clinical signs:

other: Loose stools and incoordination were the only clinical effects seen and there was observed only on the day after the dosing.

Gross pathology:

No lesions were seen in any animal.

Interpretation of results:

other: not classified

Conclusions:

The LD50 in rats is >5000 mg/kg. Based on the parameters of this study,Stoddard Solvent is not classified as an acute oral toxicant under the 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.
Five Sprague-Dawley rats of each sex were administered 5.0 g/kg of white spirit (Stoddard solvent; 14.5% aromatics) by oral gavage. No deaths occurred during the 14 days of observation. Hypoactivity and ataxia were noted in five animals

Executive summary:

The acute toxicity of Stoddard Solvent was evaluated in rats via oral gavage at a dose of 5000 mg/kg fasted body weight. Observations were made hourly for the first 4 hours immediately after dosing and twice daily (a.m. and p.m.) for the next 14 days. No animals died during the observational period. The LD50 for Stoddard Solvent in rats is >5000 mg/kg. Based on the parameters of this study, Stoddard Solvent is not classified as an acute oral 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:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

The LD50 value of >5000 mg/kg for Stoddard Solvent was determined in a rat study.
In an acute oral toxicity study, groups of fasted, young adult, Sprague Dawley rats, five male and five female, were given a single oral dose of undiluted Stoddard solvent at a dose of 5000 mg/kg bw and observed for 14 days.
There were no treatment related mortalities. All of the study animals exhibited one or more of the following clinical signs: nasal discharge, ocular discharge, abnormal stools, lethargy, stained coat, and alopecia. All animals gained weight during study period. At necropsy, one of the ten animals exhibited visual lesions, the remaining nine showed signs of alopecia in the inguinal and/or perineal regions. The oral LD50 was determined to be greater than 5000 mg/kg in males and females

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

Published data in readily available literature.Reliability score 2 on the basis of the weight of evidence found during review of public documents existing relating to toxicological data

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

GLP compliance:

yes

Test type:

fixed concentration procedure

Limit test:

no

Specific details on test material used for the study:

C9-C12 Mixed aliphatics and aromatics (8052-41-3), Boiling Point Range 160-199 °C

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Inc. Kingston, New York
- Age at study initiation: 6 to 10 days
- Weight at study initiation: males range from 311.0 to 365.5 grams; females range from 216.9 to 236.1 grams
- Housing: animals were house individually in hanging steel wire mesh cages
- Diet: during non-exposure periods-Purina Certified Laboratory Chow 5002, ad libitum; during exposure periods- none
- Water: during non-exposure periods- tap water, ad libitum; during exposure periods- none
- Acclimation period: no data reported


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 to 24°C
- Humidity (%): 43 to 54%
- Air changes (per hr): no data reported
- Photoperiod (hrs dark / hrs light): 12 hours light/ 12 hours dark

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: stainless steel and glass chamber
- Exposure chamber volume: 250 litres
- Total air flow: 2.2 cubic feet per minute
- Temperature, humidity, pressure in air chamber: test substance was introduced in a vertical counter column heated to approximately 50 degrees celsius


TEST ATMOSPHERE
- Brief description of analytical method used: the test atmosphere was analyzed by a Miran 980 infrared (IR) analyzer at intervals of five to fifteen minutes after testing commenced. The test atmosphere was analyzed gravimetrically and visually (via flashlight) for aerosols . Gravimetric measurements were generated by drawing a calibrated volume of the test atmosphere through a preweighted 25 mm Gelman Metricel filter and dividing the difference in filter weight by the sample volume. Components of the generation system and test container were weighed before and after the exposure to determined the quantity of test material consumed. The quality was divided by the total air flow through the chamber to determine the nominal exposure concentration

- Samples taken from breathing zone: yes

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

mean analytical concentration of 5.5 mg/L Stoddard solvent

No. of animals per sex per dose:

5 male, 5 female

Control animals:

no

Details on study design:

Five animals per sex were exposed to 5.5 mg/L of the test substance during a single 4 hour whole body inhalation exposure. Animals were introduced to the test substance in a 250 litre stainless steel and glass chamber. Total airflow through the chamber was 2.2 cubic feet per minute. Stoddard solvent was generated as a vapour and flowed into the chamber at a rate of 0.34 to 0.51 ml/minute from the top of a vertical counter current heated column. Prewarmed nitrogen was introduced from the bottom of the column at a rate of 7.0 L/minute. The nitrogen and test substances were mixed with air before introduction into the chamber. After 4 hours of exposure the test material generation system was turned off and residue cleared. Test animals were removed from the testing chamber and observed for fourteen days post exposure. Surviving animals were sacrificed and a gross post-mortem examinations were preformed.

Statistics:

The mean analytical exposure values were calculated, along with the nominal-to-analytical ratio..

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.5 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: Based on lack of mortality and systemic effects

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5 500 mg/m³ air

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: All animals survived; clinical signs included languid behaviour and squinted eyes

Mortality:

No test animals died during exposure or the post-exposure observation period.

Clinical signs:

other: Rats were monitored for decreased activity, soft feces, coat consistency and colour, squinted eyes, and body weight. All animals exhibited decreased activity during the third and fourth hour of exposure and on the second and third days following exposure.

Body weight:

3/5 females exhibited no weight gain during 8 day observation

Gross pathology:

During gross pathology observations, four sections of the lung were examined. The pathology report indicated that no significant histological alternations were seen.

Other findings:

All animals survived the study. Physical examination, body weight observations, and gross post-mortem and histopathological results were considered insignificant.

Interpretation of results:

other: not classified

Conclusions:

The 4 hour rat inhalational LC50 for Stoddard solvent is >5.5 mg/L (5500 mg/m3) .No deaths, languid behavior and squinted eyes; 3/5 females exhibited no weight gain during 8 day observation.
Based on zero mortality and absence of significant toxicity, body weight observations, and gross post-mortem and histopathological results, in the lungs, it is concluded that Stoddard solvent does not have acute toxic effects under the conditions of this study.

Executive summary:

In an acute inhalation toxicity study, groups of Sprague-Dawley rats, five males and five females, were exposed by inhalation route to a Stoddard solvent for 4 hours to their whole body at a single dose of 5.5 mg/L. Animals were then observed for 14 days afterwards. All animals survived the study. Physical examination, gross port-mortem and histopathological results were considered insignificant. One male rat's body weight was recorded as less than his pre-exposure body weight during post-exposure examinations, but returned to normal before being sacrificed. 3/5 females exhibited no weight gain during 8 day observation.No significant changes in body weights were noticed, for any other test animal, throughout the study. The analytical NOAEC for this study is >5.5 mg/L air. The test material is not classified according to EU criteria due to no upper limit of the NOAEC.

Reference 2

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

GLP compliance:

not specified

Test type:

acute toxic class method

Limit test:

no

Specific details on test material used for the study:

Stoddard solvent (8052-41-3) Boiling Point Range 153-194 °C

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Groups of 15-16 male Harlan-Wistar rats (age approximately 5 weeks)
- Weight at study initiation: approximately 180-350 grams for males,
- Housing: individually
- Diet (e.g. ad libitum): Fresh Certified Rodent feed, ad llibitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week (7 days)
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 64-79 °F- Humidity (%): 40 to 70 percent relative humidity
- Photoperiod (hrs dark / hrs light): 12hrs dark /12 hrs light

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

air

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

8 h

Concentrations:

2.4, 4.6 and 8.2 mg/L (maximum attainable concentration) for 8 hrs. (420, 800, and 1400 ppm)

No. of animals per sex per dose:

Groups of 15-16 male Harlan-Wistar rats (age approximately 5 weeks)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Final body weight records of the ten animals at termination (14 days) showed weight gains within expected limits of that expected in all ten animals. The animals were observed frequently on the day of exposure and daily thereafter. Survivors were weighed and necropsied at the end of the exposure period

Statistics:

No statistical test was performed.

Sex:

male

Dose descriptor:

LC50

Effect level:

> 8.2 mg/L air

Based on:

test mat.

Exp. duration:

8 h

Remarks on result:

other: No effects at 2.4 mg/L; eye irritation and nasal discharge at 4.6 and 8.2 mg/L; slight loss of coordination at 8.2 mg/L

Sex:

male

Dose descriptor:

LC50

Effect level:

> 8 200 mg/m³ air

Based on:

test mat.

Exp. duration:

8 h

Remarks on result:

other: slight loss of coordination

Mortality:

No effects at 2.4 mg/L; eye irritation and nasal discharge at 4.6 and 8.2 mg/L; slight loss of coordination at 8.2 mg/L

Clinical signs:

other: eye irritation and nasal discharge at 4.6 and 8.2 mg/L; slight loss of coordination at 8.2 mg/L

Body weight:

Body weight gain remained within expected limits for all ten animals.

Gross pathology:

Gross necropsy of the animals sacrificed at termination (14 days) showed no remarkable findings.

Other findings:

There were no other observations.

Interpretation of results:

other: not classified

Conclusions:

The rat 8 hour inhalational LC50 for Stoddard solvent is >8.2 mg/l (8200 mg/m3). No effects at 2.4 mg/L; eye irritation and nasal discharge at 4.6 and 8.2 mg/L; slight loss of coordination at 8.2 mg/L There were no signs of toxicity and findings at gross necropsy were unremarkable.

Executive summary:

 Groups of 15-16 male Harlan-Wistar rats (age approximately 5 weeks) were exposed for 8 h to 2400 mg/m3 (420 ppm), 4600 mg/m3 (800 ppm) and 8200 mg/m3 (1400 ppm) of white spirit (Stoddard solvent) (48% aliphatics, 38% cyclic aliphatics, 14% aromatics).

The rat 8 hour inhalational LC50 for Stoddard solvent is >8.2 mg/l (8200 mg/m3). No effects at 2.4 mg/L; eye irritation and nasal discharge at 4.6 and 8.2 mg/L; slight loss of coordination at 8.2 mg/L There were no signs of toxicity and findings at gross necropsy were unremarkable.

Reference 3

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Specific details on test material used for the study:

Stoddard solvent (8052-41-3) Boiling Point Range 158-204 °C

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: Bantin & Kingman, Fremont, CA- Age at study initiation: young adults (eight to twelve weeks old)
- Weight at study initiation: approximately 200 to 350 grams pre-fasting- Fasting period before study: animals were not fed the night before dosing
- Housing: individually housed in stainless steel, wire mesh bottom cages
- Diet: fresh certified Agway rodent feed provided ad libitum, feed was withheld the night before dosing
- Water: fresh potable water was provided ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS- Temperature (°C): 17 to 26 degrees Celsius, within protocol limits
- Humidity (%): 40 to 70%, within protocol limits
- Air changes (per hr): no less than ten air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

air

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

4 h

Concentrations:

11.94 mg/L

No. of animals per sex per dose:

5 female, 5 male

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Final body weight records of the ten animals at termination (14 days) showed weight gains within expected limits of that expected in all ten animals. The animals were observed frequently on the day of exposure and daily thereafter. Survivors were weighed and necropsied at the end of the exposure period

Statistics:

No statistical test was performed.

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 11.94 mg/L air

Based on:

test mat.

Exp. duration:

8 h

Remarks on result:

other: No effects at 11.94 mg/L;

Mortality:

There were no mortalities and all animals gained weight throughout the study.

Clinical signs:

other: Clinical signs were limited to two animals; in one there was a slight nasal discharge that lasted for 2 days post treatment and in the other alopecia was seen which lasted for 8 days.

Body weight:

all animals gained weight throughout the study.

Gross pathology:

At necropsy lesions were noted on the lungs of 4 male and two female animals and consisted of foci (red) on some lobes of the lung.

Other findings:

There were no other observations.

Interpretation of results:

other: not classified

Conclusions:

The rat 4 hour inhalational LC50 for Stoddard solvent is >11.94 mg/l.

Executive summary:

Five rats of each sex were exposed (whole body) to a nominal concentration of 11.94 mg/L aerosol/vapour of Stoddard solvent.The vapour was generated through a nebuliser under pressure using breathing air. Samples were taken to determine aerosol exposure levels, vapour exposure levels and particle size determinations. There were no mortalities and all animals gained weight throughout the study. Clinical signs were limited to two animals; in one there was a slight nasal discharge that lasted for 2 days post treatment and in the other alopecia was seen which lasted for 8 days. The test material is not classified according to EU criteria based on no upper limit for the LC50.

Reference 4

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Specific details on test material used for the study:

C8-C13 Mixed aliphatic and aromatics (8052-41-3)

Species:

rat

Strain:

other: Albino Rats

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
Age at study initiation: young adults (eight to twelve weeks old)
- Weight at study initiation: approximately 200 to 350 grams pre-fasting- Fasting period before study: animals were not fed the night before dosing
- Housing: individually housed in stainless steel, wire mesh bottom cages
- Diet: fresh certified Agway rodent feed provided ad libitum, feed was withheld the night before dosing
- Water: fresh potable water was provided ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS- Temperature (°C): 17 to 26 degrees Celsius, within protocol limits
- Humidity (%): 40 to 70%, within protocol limits
- Air changes (per hr): no less than ten air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

air

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

4 h

Concentrations:

12.19 mg/L

No. of animals per sex per dose:

5 female, 5 male

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Final body weight records of the ten animals at termination (14 days) showed weight gains within expected limits of that expected in all ten animals. The animals were observed frequently on the day of exposure and daily thereafter. Survivors were weighed and necropsied at the end of the exposure period

Statistics:

No statistical test was performed.

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 12.19 mg/L air

Based on:

test mat.

Exp. duration:

8 h

Remarks on result:

other: No effects at 12.19 mg/L;

Mortality:

No test animals died during exposure or the post-exposure observation period.

Clinical signs:

other: All animals exhibited decreased activity during the third and fourth hour of exposure and on the second and third days following exposure. All animals had a rough coat and yellowish hair colour for the 14 days following exposure.

Body weight:

No significant changes in body weights were noticed, for any test animal, throughout the study.

Gross pathology:

The pathology report indicated that no significant histological alternations were seen.

Other findings:

There were no other observations.

Interpretation of results:

other: not classified

Conclusions:

The rat 4 hour inhalational LC50 for Stoddard solvent is >12.19 mg/l.
All animals survived the study. Physical examination, gross port-mortem and histopathological results were considered insignificant.

Executive summary:

The rat 4 hour inhalational LC50 for Stoddard solvent is >12.19 mg/l. All animals survived the study. Physical examination, gross port-mortem and histopathological results were considered insignificant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

5 500 mg/m³ air

Quality of whole database:

The 4 hour rat inhalational LC50 for Stoddard solvent is >5.5 mg/L (5500 mg/m3) .No deaths, languid behavior and squinted eyes; 3/5 females exhibited no weight gain during 8 day observation.
Based on zero mortality and absence of significant toxicity, body weight observations, and gross post-mortem and histopathological results, in the lungs, it is concluded that Stoddard solvent does not have acute toxic effects under the conditions of this study.

Acute toxicity: via dermal route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

Reliability score 2 on the basis of the weight of evidence found during review of public documents existing relating to toxicological data

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Principles of method if other than guideline:

Four New Zealand White rabbits of each sex were exposed for 24 h with a bandage containing doses of 2.0 or 3.0 g/kg body weight of white spirit (Stoddard solvent) (14.5% aromatics). The exposed area, which measured about 10% of the body surface, was shaved before exposure and the skin of two animals in each dose group was abraded.
The rabbits were observed for a period of 14 days.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Specific details on test material used for the study:

C9-C12 Mixed aliphatics and aromatics (8052-41-3) Boiling Point Range 160-199 °C

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

5 male/female rabbits
TEST ANIMALS- Source: Alpine Laboratory Rabbits- Age at study initiation: Young adult
- Weight at study initiation: 1.9-2.40 kg at time of dosing
- Housing: Individually
- Diet (e.g. ad libitum): Purina rabbit chow, ad libitum
- Water (e.g. ad libitum): ad libitum- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 68 - 74 °F
- Humidity (%): 31 - 70% relative humidity
- Photoperiod (hrs dark / hrs light): 12/12 hour, light/dark cycle

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Four New Zealand White rabbits of each sex were exposed for 24 h with a bandage containing doses of 2.0 or 3.0 g/kg body weight of white spirit (Stoddard solvent) (14.5% aromatics). The exposed area, which measured about 10% of the body surface, was shaved before exposure and the skin of two animals in each dose group was abraded.

Duration of exposure:

24 hours

Doses:

2000 mg/kg and 3000 mg/kg

No. of animals per sex per dose:

4 male/female rabbits

Control animals:

yes

Details on study design:

Four New Zealand White rabbits of each sex were exposed for 24 h with a bandage containing doses of 2.0 or 3.0 g/kg body weight of white spirit (Stoddard solvent) (14.5% aromatics). The exposed area, which measured about 10% of the body surface, was shaved before exposure and the skin of two animals in each dose group was abraded.
All animals exhibited loss of appetite and hypoactivity on the first day after exposure. At the lowest dose level thickening and redness of the skin developed. One low-dose female with skin abrasion died three days after exposure

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no signs of systemic or organ toxicity were noted.

Mortality:

All ten animals survived to termination of the study.

Clinical signs:

other: Dermal irritation that lasted till termination of the study.

Gross pathology:

No visible lesions, with the exception of the dermal effects.

Interpretation of results:

other: not classified

Conclusions:

The LD50 for Stoddard solvent is >3000 mg/kg. Based on these findings, Stoddard solvent does not warrant classification as an acute dermal 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:

Four New Zealand White rabbits of each sex were exposed for 24 h with a bandage containing doses of 2.0 or 3.0 g/kg body weight of white spirit (Stoddard solvent) (14.5% aromatics). The exposed area, which measured about 10% of the body surface, was shaved before exposure and the skin of two animals in each dose group was abraded.

All animals exhibited loss of appetite and hypoactivity on the first day after exposure. At the lowest dose level thickening and redness of the skin developed. One low-dose female with skin abrasion died three days after exposure

Reference 2

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

Reliability score 2 on the basis of the weight of evidence found during review of public documents existing relating to toxicological data

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Specific details on test material used for the study:

C8-C13 Mixed aliphatics and aromatics (8052-41-3) Boiling Point Range 158-204 °C

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

5 male/female rabbits
TEST ANIMALS- Source: Western Oregon Rabbitry, Philomath, Oregon
- Age at study initiation: young adults
- Weight at study initiation: 2.0 to 3.5 kilograms at time of dosing
- Fasting period before study: no data provided- Housing: house separately in stainless steel, wire mesh bottom cages
- Diet: fresh certified Agway Rabbit Feed was provided ad libitum- Water: fresh potable water was provided ad libitum
- Acclimation period: 18 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 21 °C , within protocol limits
- Humidity (%): 40 to 60%, within protocol limits
- Air changes (per hr): no less than 10 air changes per hour
- Photoperiod: 12 hours light/12 hours darkIN-LIFE DATES:

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE- Area of exposure: dorsal area- % coverage: 10%
- Type of wrap if used: occlusive wrap
REMOVAL OF TEST SUBSTANCE- Washing (if done): no washing
TEST MATERIAL- Amount(s) applied (volume or weight with unit): 3160 mg/kg
- Concentration (if solution): undiluted
- Constant volume or concentration used: yes
- For solids, paste formed: not applicable

Duration of exposure:

24 hours

Doses:

3160 mg/kg

No. of animals per sex per dose:

5 male/female rabbits

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were made hourly for the first four hours immediately following dosing, and twice daily for the remainder of the study. Animal body weights were recorded at animal acquisition, day of dosing, and at day 7 and 14 after dosing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy observations

Statistics:

The mean and standard deviation for body weight data was calculated.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 160 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Based on lack of mortality and systemic effects

Mortality:

None of the animals died during exposure or post-exposure observation.

Clinical signs:

other: All of the animals exhibited one or more of the following clinical signs during the observation period: dermal irritation (erythema, edema, eschar, fissuring and/or dried skin) and/or abnormal stools.

Gross pathology:

At necropsy, dermal irritation at the test site was the only abnormal observation.

Interpretation of results:

other: not classified

Conclusions:

The LD50 for Stoddard solvent is >3160 mg/kg. Based on these findings, Stoddard solvent does not warrant classification as an acute dermal 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:

In an acute dermal toxicity study, groups of young adult New Zealand White rabbits, five males and five females, were dermally exposed to undiluted Stoddard solvent for 24 hours to 10% of their body surface area at a dose of 3160 mg/kg. Animals were then observed for 14 days. There were no mortalities and all animals gained weight during the study. All of the animals exhibited one or more of the following clinical signs during the observation period: dermal irritation (erythema, edema, eschar, fissuring and/or dried skin) and/or abnormal stools. Apart from skin irritation, there were no other abnormalities noted at necropsy. The dermal LD50 was determined to be greater than 3160 mg/kg in both males and females.

Reference 3

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

Reliability score 2 on the basis of the weight of evidence found during review of public documents existing relating to toxicological data

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Specific details on test material used for the study:

C8-C13 Mixed aliphatics and aromatics (8052-41-3)

Species:

rabbit

Strain:

other: Albino Rabbits

Sex:

male/female

Details on test animals or test system and environmental conditions:

5 male/female rabbits

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE- Area of exposure: dorsal area- % coverage: 10%
- Type of wrap if used: occlusive wrap
REMOVAL OF TEST SUBSTANCE- Washing (if done): no washing
TEST MATERIAL- Amount(s) applied (volume or weight with unit): 200 and 3160 mg/kg
- Concentration (if solution): undiluted
- Constant volume or concentration used: yes
- For solids, paste formed: not applicable

Duration of exposure:

24 hours

Doses:

200 and 3160 mg/kg

No. of animals per sex per dose:

5 male/female rabbits

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were made hourly for the first four hours immediately following dosing, and twice daily for the remainder of the study. Animal body weights were recorded at animal acquisition, day of dosing, and at day 7 and 14 after dosing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy observations

Statistics:

The mean and standard deviation for body weight data was calculated.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 160 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Based on lack of mortality and systemic effects

Mortality:

None of the animals died during exposure or post-exposure observation.

Clinical signs:

other: All of the animals exhibited one or more of the following clinical signs during the observation period: dermal irritation (erythema, edema, eschar, fissuring and/or dried skin) and/or abnormal stools.

Gross pathology:

At necropsy, dermal irritation at the test site was the only abnormal observation.

Interpretation of results:

other: not classified

Conclusions:

The LD50 for Stoddard solvent is >3160 mg/kg. Based on these findings, Stoddard solvent does not warrant classification as an acute dermal 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:

In an acute dermal toxicity study, groups of young adult Albino Rabbits, five males and five females, were dermally exposed to undiluted Stoddard solvent for 24 hours to 10% of their body surface area at a dose of 3160 mg/kg. Animals were then observed for 14 days. There were no mortalities and all animals gained weight during the study. All of the animals exhibited one or more of the following clinical signs during the observation period: dermal irritation (erythema, edema, eschar, fissuring and/or dried skin) and/or abnormal stools. Apart from skin irritation, there were no other abnormalities noted at necropsy. The dermal LD50 was determined to be greater than 3160 mg/kg in both males and females.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

3 000 mg/kg bw

Quality of whole database:

The LD50 for Stoddard solvent is >3000 mg/kg. Based on these findings, Stoddard solvent does not warrant classification as an acute dermal 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.

Additional information

Acute oral toxicity:

The oral LD50 of 18.3% talc in saline was >5000 mg/kg. A single oral dose of 5000 mg/kg of talc prepared as an 18.3% (w/v) suspension in saline was administered to 10 male rats. All animals survived, and there were no signs of toxicity.

 

Acute dermal toxicity:

 

The LD50 for Stoddard solvent is >3000 mg/kg. Based on these findings, Stoddard solvent does not warrant classification as an acute dermal 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.

 

Acute inhalation toxicity:

 

The 4 hour rat inhalational LC50 for Stoddard solvent is >5.5 mg/L (5500 mg/m3) .No deaths, languid behavior and squinted eyes; 3/5 females exhibited no weight gain during 8 day observation. Based on zero mortality and absence of significant toxicity, body weight observations, and gross post-mortem and histopathological results, in the lungs, it is concluded that Stoddard solvent does not have acute toxic effects under the conditions of this study.

Justification for classification or non-classification

Based on the hazard assessment of Stoddard solvent, in section 2.1 and 2.2. in IUCLID 6., available data for the substance and following the “Guidance on Information Requirement and Chemical Safety Assessment R.8. Characterisation of dose [concentration]- response for human health”, according to the EU’s list of dangerous substances (OJEC No L200/130.7.99) and according to the criteria described in Directive 67/548 and in the CLP Regulation:

 

Directive 67/548

Very Toxic (T+) R28: Very toxic if swallowed R27: Very toxic in contact with skin R26: Very toxic by inhalation R39/26 R39/27 R39/28: Dangerous of very serious irreversible effects Toxic (T):  R25: Toxic if swallowed R24: Toxic in contact with skin R23: Toxic by inhalation R39/23 R39/24 R39/25: Danger of very serious irreversible effects Harmful (Xn): R22: Harmful if swallowed R21: Harmful in contact with skin R20: Harmful by inhalation R65: Harmful may cause lung damage if swallowed R21/22 Harmful; Harmful in contact with skin and if swallowed. R68/20 R68/21 R68/22: Possible risk of irreversible effects Other toxicological properties R67: Vapours may cause drowsiness and dizziness

CLP

H300 Acute Tox. 2 Fatal if swallowed H310 Acute Tox. 1 Fatal in contact with skin H330 Acute Tox. 2 Fatal if inhaled H370 STOT SE 1 H301 Acute Tox. 3 Toxic if swallowed H311 Acute Tox. 3 Toxic in contact with skin H331 Acute Tox. 3 Toxic if inhaled H370 STOT SE 1 H302 Acute Tox. 4 Harmful if swallowed H312 Acute Tox. 4 Harmful in contact with skin H332 Acute Tox. 4 Harmful if inhaled H304 Asp. Tox. 1 H371 STOT SE 2 (May cause damage to organs (or state all organsaffected if known) (state route of exposure if it is conclusively proventhat no other routes of exposure cause the hazard) Other toxicological properties H336 STOT SE 3 May cause drowsiness or dizziness

 

 

It is concluded that the substance Stoddard solvent does not meet the criteria to be classified for human health hazards for Acute dose toxicity.