Asphalt, sulfonated, sodium salt

Endpoint summary

Description of key information

ACUTE ORAL TOXICITY: SAS has been tested for acute toxicity via the oral route and exhibits a low order of toxicity. Two acute studies on two separate commercial products containing approximately 85% SAS have been conducted according to the Environmental Protection Agency requirements, 40 CFR 158-135. The LD50 for these two commercial products was estimated to be greater than 5000 mg/kg of body weight (equivalent to 4,250 mg SAS/kg bw) in both male and female rats.

ACUTE DERMAL TOXICITY: Acute dermal toxicity studies were not available for SAS.  

ACUTE INHALATION TOXICITY: SAS has been tested for acute toxicity via the inhalation route. In the key acute inhalation toxicity study, conducted according to OECD TG 403 and in compliance with GLP, the reported LC50 value was greater than 5.3 mg/L air (WIL, 2014).

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:

1985-09-18 to 1985-10-16

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

according to guideline

Guideline:

other: EPA requirements, 40 CFR 158.135

Deviations:

no

Principles of method if other than guideline:

Method References: Acute oral toxicity study in rats-EPA Assessment Guidelines, Subdivision F: Hazard Evaluation: Human and Domestic Animals, Series 81-1 (November 1982) and Revised Acute Toxicity Testing Guidelines, Acute Exposure Oral Toxicity, October 1984. Good Laboratory Practice Standards, Federal Register, November 29, 1983.

GLP compliance:

yes

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: Charles River Breeding Laboratories, Inc., Kingston, NY
- Age at study initiation: young adult
- Weight at study initiation: Initial body weights of the males ranged from 252.4 to 299.0 g, and the initial body weights of the females ranged from 227.6 to 264.7 g
- Fasting period before study: Food was withheld overnight before test substance administration, but water was available.
- Housing: Animals were maintained individually in elevated wire-mesh cages.
- Diet (e.g. ad libitum): ad libitum except during fasting period
- Water (e.g. ad libitum): ad libitum
- Acclimation period: ~1 week


ENVIRONMENTAL CONDITIONS
- Temperature (deg. C): Animal quarters were temperature-controlled. No further information was provided.
- Humidity (%): Animal quarters were humidity-monitored. No further information was provided.
- Air changes (per hr): N/A
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 1985-10-02 To: 1985-10-16

Route of administration:

oral: gavage

Vehicle:

other: Polar Distilled Water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: N/A
- Amount of vehicle (if gavage): dosage factor was 20 mL/kg
- Justification for choice of vehicle: N/A
- Lot/batch no. (if required): 51267
- Purity: N/A


MAXIMUM DOSE VOLUME APPLIED: N/A


DOSAGE PREPARATION (if unusual):The required amount of test substance was weighed on an appropriate balance and placed into pre-calibrated glass beakers. Distilled water was added to each beaker to bring the mixture to the desired volume. The mixtures were stirred on a Tekmar Tissue Miser for approximately 2-3 minutes and then on a magnetic stirrer for approximately 3-4 minutes. All mixtures were stirred while dosing. The test substance was assumed to be 100 % pure for purposes of dosage calculations.


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Dose level was selected based on a range-finding study.

Doses:

5000 mg/kg

No. of animals per sex per dose:

5 per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Each animal was observed for signs of toxic and pharmacologic effects at 1, 2 and 4 hours after administration and once daily thereafter to 14 days. Mortality/moribundity was recorded twice daily. Individual body weights were recorded immediately prior to treatment, at 7 days and at termination.
- Necropsy of survivors performed: yes; observations were recorded.
- Other examinations performed: N/A

Statistics:

N/A

Preliminary study:

Materials and Methods:
-One rat/sex was dosed at levels of 1000, 2000, 3000, 4000 and 5000 mg/kg bw (initial body weights of males ranged from 205.7 to 221.8 g, and the initial body weights of females ranged from 203.0 to 236.1 g).
-Each animal was observed for signs of toxic and pharmacologic effects at 1, 2, 4, 24 and 48 hours after administration. Mortality/moribundity was recorded twice daily. Individual body weights were recorded immediately prior to treatment and at termination. At termination, all rats were sacrificed and observations were recorded.
Results:
-No animals were found dead.
-Clinical signs were limited to instances of soft feces and/or a rough coat in all groups at one or more intervals. All animals gained weight from initiation to termination.
- Gross pathology findings noted were limited to pale adrenals in Groups 1-3 (1000 mg/kg, 2000 mg/kg, and 3000 mg/kg) and Group 5 (5000 mg/kg) males and in Group 2 (2000 mg/kg) and Groups 4-5 (4000 mg/kg and 5000 mg/kg) females, and dark adrenals were noted in the Group 4 (4000 mg/kg) males.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks:

No animals died in the study.

Remarks on result:

other: equivalent to an LD50 of >4250 mg SAS/kg bw

Mortality:

No animals were found dead.

Clinical signs:

other: -Clinical signs noted consisted of soft feces in three males and all females at one hour post dose, in all animals at two and four hours, and a rough coat in all animals on Day 1. All animals appeared normal from Day 2 through termination.

Gross pathology:

No observable gross pathology was noted in any of the animals upon necropsy.

Other findings:

N/A

N/A

Interpretation of results:

GHS criteria not met

Conclusions:

Based upon the results of this study, the LD50 was estimated to be greater than 5000 mg/kg of body weight in both female and male rats.

Executive summary:

N/A

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985-10-04 to 1985-10-18

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

according to guideline

Guideline:

other: EPA requirements, 40 CFR 158.135

Deviations:

no

Principles of method if other than guideline:

Method References: Acute oral toxicity study in rats-EPA Assessment Guidelines, Subdivision F: Hazard Evaluation: Human and Domestic Animals, Series 81-1 (November 1982) and Revised Acute Toxicity Testing Guidelines, Acute Exposure Oral Toxicity, October 1984. Good Laboratory Practice Standards, Federal Register, November 29, 1983.

GLP compliance:

yes

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: Charles River Breeding Laboratories, Inc., Kingston, NY
- Age at study initiation: young adult
- Weight at study initiation: Initial body weights of the males ranged from 290.6 to 300.8 g, and the initial body weights of the females ranged from 237.1 to 258.8 g.
- Fasting period before study: Food was withheld overnight before test substance administration, but water was available.
- Housing: Animals were maintained individually in elevated wire-mesh cages.
- Diet (e.g. ad libitum): ad libitum except during fasting period
- Water (e.g. ad libitum): ad libitum
- Acclimation period: ~1 week


ENVIRONMENTAL CONDITIONS
- Temperature (deg. C): Animal quarters were temperature-controlled. No further information was provided.
- Humidity (%): Animal quarters were humidity-monitored. No further information was provided.
- Air changes (per hr): N/A
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 1985-10-04 To: 1985-10-18

Route of administration:

oral: gavage

Vehicle:

other: Polar Distilled water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: N/A
- Amount of vehicle (if gavage): Dosage factor was 20 mL/kg.
- Justification for choice of vehicle: N/A
- Lot/batch no. (if required): 51267
- Purity: N/A


MAXIMUM DOSE VOLUME APPLIED: N/A


DOSAGE PREPARATION (if unusual): The test substance was first ground with a mortar and pestle and then the required amount of test substance was weighed on an appropriate electronic balance and placed into pre-calibrated glass beakers. A small amount of distilled water (2-4 mL) was added and mixed into paste. The remaining required amount of distilled water was then added to each beaker to bring the mixture to the desired volume. The mixtures were stirred on a Tekmar Tissue Miser and then stirred on magnetic stirrer for approximately five minutes. All mixtures were stirred while dosing. The test substance was assumed to be 100 % pure for purposes of dosage calculations.


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Dose level was chosen based on a range-finding study.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 rats per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Each animal was observed for signs of toxic and pharmacologic effects at 1, 2 and 4 hours after administration and once daily thereafter to 14 days. Mortality/moribundity was recorded twice daily. Individual body weights were recorded immediately prior to treatment, at 7 days and at termination.
- Necropsy of survivors performed: yes; observations were recorded.
- Other examinations performed: N/A

Statistics:

N/A

Preliminary study:

Materials and Methods:
-One rat/sex was dosed at levels of 1000, 2000, 3000, 4000 and 5000 mg/kg bw (initial body weights of males ranged from 209.0 to 233.8 g, and the initial body weights of females ranged from 222.4 to 232.1 g).
-Each animal was observed for signs of toxic and pharmacologic effects at 1, 2, 4, 24 and 48 hours after administration. Mortality/moribundity was recorded twice daily. Individual body weights were recorded immediately prior to treatment and at termination. At termination, all rats were sacrificed and observations were recorded.
Results:
-No animals were found dead.
-Clinical signs were limited to instances of soft feces and/or a rough coat in all groups. All rats appeared normal at termination. All animals gained weight from initiation to termination.
- Gross pathology findings noted were limited to bright red lungs in the Group 4 (4000 mg/kg) females and pale adrenals in the Group 5 (5000 mg/kg) females.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks:

No deaths occurred in the study.

Remarks on result:

other: equivalent to an LD50 of >4250 mg SAS/kg bw

Mortality:

No animals were found dead.

Clinical signs:

other: Clinical signs were noted among all animals and consisted of soft feces, a rough coat and/or red stains on the nose and/or eyes at one or more intervals during the study. All animals appeared normal from Day 3 through termination. All animals gained weigh

Gross pathology:

No observable gross pathology was noted in any of the animals upon necropsy.

Other findings:

N/A

N/A

Interpretation of results:

GHS criteria not met

Conclusions:

Based upon the results of this study, the LD50 was estimated to be greater than 5000 mg/kg of body weight in both male and female rats.

Executive summary:

N/A

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 February 2014 to 25 April 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Version / remarks:

2009

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1300 (Acute inhalation toxicity)

Version / remarks:

1998

Deviations:

no

GLP compliance:

yes

Test type:

traditional method

Limit test:

yes

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
- Stability under test conditions: not specified
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: not specified
- Preliminary purification step (if any): not specified

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, USA
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation: 9 weeks old
- Weight at study initiation: 317 - 346 g males, 225 - 248 g for females.
- Fasting period before study: none
- Housing: All animals were housed individually in suspended wire-mesh cages.
- Diet: A certified feed with appropriate analysis performed by the manufacturer, ad libitum. No contaminants were present in animal feed.
- Water: Reverse osmosis-treated water supplying the facility, ad libitum. No contaminants were present in water.
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): 10 / hour
- Photoperiod (hrs dark / hrs light): 12/ 12

Route of administration:

inhalation: dust

Type of inhalation exposure:

nose only

Vehicle:

air

Mass median aerodynamic diameter (MMAD):

3.4 µm

Geometric standard deviation (GSD):

2.85

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: The exposure was conducted using a 7.9 - L stainless steel, convensional nose-only exposure system with synthetic rubber grommets in exposure ports to engage the animal holding tubes.
- Exposure chamber volume: 7.9 L
- Method of holding animals in test chamber: Animals were restrained in nose-only exposure holding tubes during exposure.
- Source and rate of air: Airflow rates through the system were determined from the aerosol generation and the dilution airflow and provided a minimum of 12 air changes per hour through the exposure system. Airflow through the exposure system was provided using a dry, breathing quality , in-house, compressed air source. Exposure atmosphere environmental conditions were recorded at approximately 60-minute intervals during the exposure. Dry compressed air was supplied to the micronizing and inlet ports of the jet mill using 2 regulators. The resulting aerosol from the jet mill was delivered to a 4.8L glass chromatography jar and then to a "T"-fitting at the inlet of the nose-only exposure system through 22-mm corrugated respiratory tubing.
- Method of conditioning air: At the "T-fitting, humidified dilution air was added using a Coilhose Pneumatics regulator. The flow of dilution air was controlled using a rotameter-type flowmeter. Humidified dilution air was produced by passing dry compressed air through a muffler-type bubbler submerged in a 2-L Erlenmeyer flask filled with DI water.
- System of generating particulates/aerosols: A dust aerosol atmosphere of the test substance was generated. The test substance was delivered using an auher-type feeder which fed test substance at a constant rate to a jet mill air micronizer operating as a particle size reduction and dispersion device. The AccuRate feeder was equipped with a 3/8-inch solid core auger. The feeder and jet mill were equipped with Syntron magnetic vibrators.
- Method of particle size determination: Four aerosol particle size measurements were conducted during exposure using a 7-stage cascade impactor. Pre-weighed, 25 mm glass-fiber filters were used as the collection substances. Samples were collected at 1.8 L/minute for 0.25 minutes. The filters were re-weighed and the particle size was calculated based on the impactor stage cut-offs.
- Treatment of exhaust air: Exhaust atmosphere was filtered using a Solberg filter prior to entering the in-house exhaust system which included activated charcoal- and HEPA-filtration.
- Temperature, humidity, pressure in air chamber: A temperature and relative humidity transmitter probe was used with a display unit to monitor temperature and percent relative humidity. Oxigen content was measured during the pre-exposure method development phase using a Drager PAC III equipped with a calibrated oxygeb sensor.

TEST ATMOSPHERE
- Brief description of analytical method used: Actual exposure concentrations were determined using standard gravimetric methods. Samples were collected on pre-weighed, 25-mm glass fiber filters held in a closed-faced filter holder positioned in the animal exposure port of the nose-only exposure system. A measured volume of the exposure atmosphere was pulled through the filter to quantitatively collect aerosol particles. Following sample collection, the filters were re-weighed and the concentration calculated as the filter weight difference divided by the sample volume. Samples were collected at approximately 1L/ minute for 0.5 minutes.
- Samples taken from breathing zone: yes


TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: Particle size distribution was calculated based on the impactor stage cut-offs.
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): The aerosol size was expressed as the mass median aerodynamic diameter (MMAD) and the geometric standard deviation (GSD). Three of the particle size measurements were used to calculate the mean particle size for the exposure. The second sample was excluded due to a sampling error in which a large bolus of test material was inadvertently drawn into the impactor during sampling.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: inhalation exposure as a dust aerosol at a concentration of 5.3 mg/L

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

Target exposure concentration: 5 mg/L
Actual exposure concentration: 5.3 mg/L
Nominal concentration: 18.2 mg/L

No. of animals per sex per dose:

10 males and 10 females

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Each animal was observed for mortality at the approximate midpoint of exposure. Thereafter, all recovery animals were observed for mortality and moribundity twice daily during the study period. Body weights were obtained prior to exposure on study day 0 for all animals and on post-exposure days 3, 7, and 14 for recovery animals.
- Necropsy of survivors performed: yes. Necropsies were conducted on 5 animals/sex after exposure (primary necropsy) and on 5 animals/sex after a 14-day non-exposure recovery period (recovery necropsy).
- Other examinations performed: clinical signs, body weight,organ weights, histopathology (lungs)

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.3 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Mortality:

None of the animals died during the exposure or during the 14-day study period.

Clinical signs:

other: Partial exposure of the left or right eye was observed for 3 females and 2 females, respectively, immediately after exposure. Partial closure of the left eye was observed for 1 female at the 2-hour post-exposure observation period. Brown material on the f

Body weight:

All recovery animals surpassed their initial body weight by study day 14 and were considered normal.

Gross pathology:

Mottled lungs or brown discolouration of the lungs were noted in all of the test animals in the primary and recovery necropsies. This correlated with the presence of brown pigment within the lungs. Brown matting of the skin and dark red contents of the stomach were noted in males and females from the study day 0 primary necropsy. This was considered to be related to test substance exposure due to the high insidence of observation.

Other findings:

- Organ weights: Mean lung weights and most individual animal lung weights for animals from the study day 0 primary necropsy were within the WIL Research historical control data range. Lung weights of the test substance-exposed males and females at the study day 14 recovery necropsy were higher than the range of the WIL Research historical control data, including both the group mean values and many individual animal values.
- Histopathology: Microscopic findings considered to be associated with test substance exposure were noted in the lungs of males and females from the primary and recovery necropsies. Brown granular consistent with particulate matter pigment was present within the lungs of all animals from the primary and recovery necropsies. This finding was of a similar severity in animals from the primary and recovery necropsies, but was present in different locations of the lung tissue. The particulate matter was present free within the air spaces, as well as within the alveolar macrophages and was scattered throughout the section including within large bronchioles and bronchi. In animals from the recovery necropsy, the particulate matter was predominantly within alveolar macrophages and located within small bronchioles or alveoli. This pattern of distribution would be expected with normal functioning of alveolar macrophages in clearing particulate matter from the lung. Epithelial degeneration was observed within the bronchioles of animals from the primary necropsy. This change consisted of loss of cilia and attenuation or rounding of cells with blebbing of the apical cytoplasm and/or shedding of cells into the bronchiolar lumen. This change was not observed in animals from the recovery necropsy, indicating reversibility. Several components of acute inflammation were observed within the lungs of animals from the primary necropsy, including neutrophilic infiltrate within the interstitium, edema, and hemorrhage. These changes were also observed in some animals from the recovery necropsy but were seen at a lower incidence and severity. Atelectasis was present within the lungs of all animals but was more severe in animals from the primary necropsy.

Interpretation of results:

GHS criteria not met

Conclusions:

In the acute inhalation toxicity study, conducted according to OECD TG 403 and in compliance with GLP, the reported LC50 value was greater than 5.3 mg/L air. Exposure resulted in mottling or brown discoloration of the lungs, which persisted after a 14-day non-exposure (recovery) period. Exposure also resulted in brown matting of the skin and dark red contents in the stomach, which resolved during the recovery period. Higher lung weights were noted after the 14-day non-dosing recovery period.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

5 300 mg/m³ air

Additional information

Acute studies on two products containing approximately 85% SAS demonstrated no toxicity concern via the oral route of exposure (LD50> 4,250 mg SAS/kg body weight). Therefore, it would appear that oral exposure to 100% SAS will also exhibit a low order of toxicity. An acute inhalation toxicity study did not show systemic toxicity; the LC50 value was greater than 5.3 mg/L air. No acute dermal toxicity studies were available for sulfonated asphalt sodium salt.

ACUTE ORAL TOXICITY: Two acute studies on two separate commercial products containing approximately 85% SAS have been conducted according to the Environmental Protection Agency requirements, 40 CFR 158-135. The LD50 for these two commercial products was estimated to be greater than 5000 mg/kg of body weight in both male and female rats.

Following oral gavage administration of 5000 mg/kg bw of test material to 5 male and 5 female rats, no mortality occurred during the 14 -day observation period in both studies. Soft feces and rough coat were observed in male and female animals in the two studies. In addition, red stains on the nose and/or eyes were noted in animals of the second study. All animals appeared normal from day 2 or 3. The expected body weight gain was noted in all the animals.

ACUTE DERMAL TOXICITY: Acute dermal toxicity studies were not available for SAS.

ACUTE INHALATION TOXICITY: In the key acute inhalation toxicity study, conducted according to OECD TG 403 and in compliance with GLP, the reported LC50 value was greater than 5.3 mg/L air (WIL, 2014).

Following a 4 -hour nose-only inhalation exposure of 10 male and 10 female rats to 5.3 mg/L of a dust aerosol of the test substance, no mortality occurred during the 14-day observation period. The only significant clinical observation was partial closure of the eyes at 2 hour post-exposure observation. All other animals appeared normal throughout the study period. Slight body weight loss was noted in 1 male and 1 female during study days 0 to 3. No other changes in body weight were noted for the rest of the animals. Necropsies were conducted on 5 animals/ sex after exposure (primary necropsy) and on 5 animals/ sex after a 14 -day non-exposure recovery period (recovery necropsy). The lungs were weighed at each necropsy and examined microscopically. Mottled lungs or brown discolouration of the lungs were noted in all of the test substance-exposed animals at the primary and recovery necropsies. Microscopically, this correlated with the presence of brown pigment within the lungs of all animals from the primary and recovery necropsies, but in different locations of the lung tissue. In animals from the primary necropsy, the particulate matter was present free within the air spaces, as well as within the alveolar macrophages, and was scattered throughout the section, including within large bronchioles and bronchi. In animals from the recovery necropsy, the particulate matter was predominantly within alveolar macrophages and located within small bronchioles or alveoli. The pigment was granular and was considered to deposition of the test substance. Epithelial degeneration was observed within the bronchioles of animals from the primary necropsy. This change was not observed in animals from the recovery necropsy, indicating reversibility. Acute inflammation including neutrophilic infiltrate within the interstitum, oedema and haemorrhage was observed within the lungs of animals from the primary necropsy. A statistically significantly lower area fraction of particulate matter was found in the lungs of animals examined after the recovery period than in the lungs of animals examined in the primary necropsy.

Justification for classification or non-classification

Acute oral toxicity: The available SAS data do not support a classification based on LD50 of > 4,250 mg SAS/kg of body weight in both male and female rats of two separate commercial products containing approximately 85% SAS (Hazelton Laboratories, 1985a, b). Based on the results, no classification is proposed under EU DSD or CLP/GHS.

Acute dermal toxicity: Reason for no classification: data lacking.

Acute inhalation toxicity: The available SAS data do not support a classification based on LC50 value of > 5.3 mg/L in both male and female rats.