Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

Administrative data

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

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:
yes
Test type:
other: Approximate lethal concentration (ALC)
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium dodecylbenzenesulfonate
EC Number:
246-680-4
EC Name:
Sodium dodecylbenzenesulfonate
Cas Number:
25155-30-0
Molecular formula:
C18H30NaO3S
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%
Sodium dodecylbenzenesulfonate (CAS# 25155-30-0 , EC Number; 246-680-4 ) is a very close analogue of Calcium dodecylbenzenesulfonate (CAS No 26264-06-2, EC Number; 247-557-8) ) and read-across is valid.

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 levelsopen allclose all
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.
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.

 

Categories Display