Sodium dodecylbenzenesulfonate

Acute Toxicity: inhalation

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Groups of six male 8-week old rats were restrained in perforated, stainless steel cylinders with conical nose pieces. Exposure was nose-only to an aerosol atmosphere for 4 hours. After exposure, rats were returned to their cages and observed for clinical signs for 14 days. Mean measured concentrations in the test chambers were 65, 120, 260, and 310 mg/m3. Chamber temperature ranged between 25-26oC.

GLP compliance:

not specified

Test type:

other: Approximate lethal concentration (ALC)

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium dodecylbenzenesulfonate

EC Number:

246-680-4

EC Name:

Sodium dodecylbenzenesulfonate

Cas Number:

25155-30-0

Molecular formula:

C18H29NaO3S

IUPAC Name:

sodium dodecylbenzenesulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: particulates

Details on test material:

LAS (CAS #25155-30-0); dodecylbenzene sulfonic acid, sodium salt; activity 98%

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Spague-Dawley,
- Age at study initiation: 8-week old
- Housing: stainless steel cylinders with conical nose pieces.
- Acclimation period: approximately one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25 to 26
- Humidity (%): 40 to 70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

other: Exposure was nose-only to an aerosol atmosphere for 4 hours.

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
-Exposure was nose-only to an aerosol atmosphere for 4 hours.
- After exposure, rats were returned to their cages and observed for clinical signs or 14 days.
-Mean measured concentrations in the test chambers were 65, 120, 260, and 310 mg/m3.
-Chamber temperature ranged between 25-26oC.

TEST ATMOSPHERE
-Animals were given high exposures to respirable-sized particles (MMAD at 310 mg/m3 = 2.5 microns).
-Spray products containing LAS are designed to produce large particle sizes.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

ca. 4 h

Concentrations:

65, 120, 260, and 310 mg/m3.

No. of animals per sex per dose:

6 male 8-week old rats

Control animals:

yes

Details on study design:

-Groups of six male 8-week old rats were restrained in perforated, stainless steel cylinders with conical nose pieces.
-Exposure was nose-only to an aerosol atmosphere for 4 hours.
-After exposure, rats were returned to their cages and observed for clinical signs for 14 days.
-Mean measured concentrations in the test chambers were 65, 120, 260, and 310 mg/m3.
-Chamber temperature ranged between 25-26oC.
-Animals were given high exposures to respirable-sized particles (MMAD at 310 mg/m3 = 2.5 microns).
-Spray products containing LAS are designed to produce large particle sizes.
-These large particles are needed for efficient delivery of the spray to the surface being cleaned.

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LC50

Effect level:

310 mg/m³ air

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: Approximate lethal concentration (ALC).The ALC is defined as the lowest atmospheric concentration generated that caused death in 1 or more rats either on the day of exposure or within 14 days post exposure.

Effect levels 2

Sex:

male

Dose descriptor:

other: NOEC

Effect level:

260 mg/m³ air

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: Based on No mortality occurred at concentrations up to 260 mg/m3.

Mortality:

At 310 mg/m3, one rat died during exposure and 2 rats died one day post exposure.
No mortality occurred at concentrations up to 260 mg/m3.

Clinical signs:

other: Particle sizes are much larger than the respirable particle sizes used in testing and therefore would not be able to reach far into the lungs where effects could occur.

Body weight:

During the recovery period, rats exhibited dose dependent weight loss 1 day post exposure followed by normal weight gains.

Gross pathology:

none

Any other information on results incl. tables

The ALC is defined as the lowest atmospheric concentration generated that caused death in one or more rates either on the day of exposure or within 14 days post exposure. No mortality occurred at concentrations up to 260 mg/m3. At 310 mg/m3 one rat died during exposure and two rats died one day post exposure. The test material is considered moderately toxic by inhalation. However, it is important to note that this laboratory exposure is not representative of the possible LAS exposure during actual use. In this study, animals were given high exposures to respirable-sized particles (MMAD at 310 mg/m3 = 2.5 microns). Spray products containing LAS are designed to produce large particle sizes. These large particles are needed for efficient delivery of the spray to the surfaces being cleaned. This results in particle sizes that are much larger than the respirable particle sizes used in testing and therefore would not be able to reach far into the lungs where effects would occur. Given this lack of relevance to real-world exposure potential, this use of this study beyond establishing the relative toxicity of the chemical is limited.

 

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Remarks:

Particle sizes are much larger than the respirable particle sizes used in testing and therefore would not be able to reach far into the lungs where effects could occur. Criteria used for interpretation of results: EU

Conclusions:

Based on this study, exposure of 6 male rats to Sodium dodecylbenzenesulfonate the LC50 was 310 mg/m3 (particulate). At 310 mg/m3 one rat died during exposure and two rats died one day post exposure. No mortality occurred at concentrations up to 260 mg/m3.(NOEC). Therefore, the health effects of Sodium dodecylbenzenesulfonate need to be considered in the assessment of Dodecylbenzenesulfonic acid.
This results in particle sizes that are much larger than the respirable particle sizes used in testing and, therefore, would not be able to reach far into the lungs where effects could occur. Given this lack of relevance to real-world exposure potential, the use of this study for risk assessment purposes is limited.
Given this lack of relevance to real-world exposure potential, the use of this acute inhalation study for risk assessment purposes is limited. Due to the irritant nature of LAS, it is expected that high LAS aerosol concentrations may be irritating to the upper respiratory tract.

Executive summary:

Based on this study, exposure of 6 male rats to Sodium dodecylbenzenesulfonate  the LC50 was310 mg/m3(particulate).At 310 mg/m3 one rat died during exposure and two rats died one day post exposure. No mortality occurred at concentrations up to 260 mg/m3.(NOEC).Therefore, the health effects of Sodium dodecylbenzenesulfonate need to be considered in the assessment of Dodecylbenzenesulfonic acid.

However, it is important to note that this laboratory exposure is not representative of the possible LAS exposure during actual use. In this study, animals were given high exposures to respirable-sized particles (MMAD at 310 mg/m3 = 2.5 microns). Spray products containing LAS are designed to produce large particle sizes. These large particles are needed for efficient delivery of the spray to the surfaces being cleaned. This results in particle sizes that are much larger than the respirable particle sizes used in testing and therefore would not be able to reach far into the lungs where effects would occur. Given this lack of relevance to real-world exposure potential, this use of this study beyond establishing the relative toxicity of the chemical is limited.