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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Study period:
9/13/1983-12/02/1983
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Test substance identity is uncertain and not representative of LAS; study lacks proper analytical information.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Water control not included. 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.
GLP compliance:
no
Test type:
other: Approximate lethal concentration (ALC)
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
aerosol dispenser: not specified
Details on test material:
- Name of test material (as cited in study report): Sodium Dodecylbenzene Sulfonate
- Physical state: liquid
- Analytical purity: 98%
- Impurities (identity and concentrations): 1% sodium xylene sulfonate, 0.5% sodium sulfate, 0.5% free oil
- Composition of test material, percentage of components: 26.8% Sodium dodecylbenzenesulfonate, 70% water
- Stability under test conditions: stable
- Other: Industry has used the term “sodium dodecylbenzenesulfonate” for everything from pure C12 LAS (homologue) to the normal detergent range substance (LAS) to even (at least in the literature) branched alkylbenzene sulfonate (ABS). The terms “Slurry 1260” or Sulfonium 1260” are not found either in the 2008 LAS SIDS dossier or in an internet search of synonyms for LAS. The test substance is noted to contain sodium xylene sulfonate (SXS), which is not formed in the production of LAS and thus must have been added to the sample. This is further evidence that the sample is not representative of LAS.

Test animals

Species:
rat
Strain:
other: CD (SD) BR
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Kingston, NY
- Age at study initiation: 8 weeks
- Weight at study initiation: 222-273 g
- Housing: Singly in 5" x 11" x 7" steel-mesh cages
- Diet (e.g. ad libitum): Purina Certified Rodent Chow #5002 ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25-26 degrees C
- Humidity (%): 29-54%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: conical nose pieces
- Method of holding animals in test chamber: perforated stainless steel cylinders
- System of generating particulates/aerosols: Test material was pumped into a nebulizer. The aerosol stream went through a cyclone elutriator.


TEST ATMOSPHERE
- Brief description of analytical method used: Particle concentrations was taken about every 30 min, by drawing atmosphere through pre-weighed glass fiber filters. Atmospheric concentration was deterimined by weighing the filters after sampling. MMAD was determined by a Sierra Cascade Impactor.


VEHICLE
- Composition of vehicle (if applicable): distilled water
- Concentration of test material in vehicle (if applicable): 1.5-12% active ingredient


TEST ATMOSPHERE (if not tabulated)
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 2.5 microns
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
4 h
Concentrations:
65, 120, 260, and 310 mg/m3
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
other: Acute Lethal Concentration
Effect level:
310 mg/m³ air
Based on:
not specified
Exp. duration:
4 h
Mortality:
At 310 mg/m3, one rat died during exposure and 2 rats died one day post exposure.
Clinical signs:
Clear to red nasal discharge in all rats. Rats showed a diminishing response to having their cages tapped in the 260 and 310 mg/m3 groups. 1 rat in the 310 mg/m3 group had red nasal discharge 2 days post exposure.
Body weight:
Slight to severe weight loss 1 day post exposure.

Any other information on results incl. tables

An assumption that the test article aerosolized (a mix of water and the test substance and other components) was a homologous mixture and that this mixture was stable for the entire dosing period. Typically one would conduct analytical measurements of the active material from the sampled air from the test chamber (and not rely on a calculated value). Instead the study assumes that the particles samples from the test chamber contained the active ingredient based on the mathematical calculation from dilution in water. If for some reason the particles were not a homologous mix, then one could be over or under estimating the air concentration of active material.

Applicant's summary and conclusion

Interpretation of results:
moderately toxic
Remarks:
Criteria used for interpretation of results: other: Approximate lethal concentration (ALC)
Conclusions:
No mortality occurred at concentrations up to 260 mg/m3. At 310 mg/m3, one rat died during exposure and 2 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. Given this lack of relevance to real-world exposure potential, the use of this study for risk assessment purposes is limited.
Executive summary:

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