Registration Dossier

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:
data from handbook or collection of data

Data source

Reference
Reference Type:
review article or handbook
Title:
Environmental and human safety of major surfactants. Volume 1. Anionic surfactants. Part 4. Alpha olefin sulfonates
Author:
Little, A.D.
Year:
1993
Bibliographic source:
National Technical Service (NTIS) report No. PB94-102423

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
limited documentation in review article
GLP compliance:
not specified
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
aerosol dispenser: not specified
Remarks:
migrated information: aerosol
Details on test material:
- Name of test material (as cited in study report): C14-C16 AOS
- Analytical purity: no data

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
not specified
Vehicle:
other: no data
Details on inhalation exposure:
TEST ATMOSPHERE (if not tabulated)
- Information on particle size for either treatment was unavailable


Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
1 h
Concentrations:
- 90% active of powdered aerosol of C14-C16 AOS flake at a concentration of 229mg/L
- 17% active of powdered aerosol of spray dried formulation of C14-C16 AOS at a concentration of 221mg/L
No. of animals per sex per dose:
10 rats, no sex specified
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes, immediately after exposure 5 rats from each group and from the remaining animals after a 14 day observation period
- Other examinations performed: gross pathological changes

Results and discussion

Effect levelsopen allclose all
Sex:
not specified
Dose descriptor:
LC50
Effect level:
> 52 mg/L air
Based on:
act. ingr.
Exp. duration:
4 h
Remarks on result:
other: converted from 1h to 4h exposure based on Haber's law and guidance of CLP regulation
Sex:
not specified
Dose descriptor:
LC50
Effect level:
> 206 mg/L air
Based on:
act. ingr.
Exp. duration:
1 h
Remarks on result:
other: recalculated to active ingredient
Sex:
not specified
Dose descriptor:
LC50
Effect level:
> 229 mg/L air
Based on:
test mat.
Exp. duration:
1 h
Mortality:
no mortalities reported
Clinical signs:
other: indistinguishable from controls
Body weight:
indistinguishable from controls
Gross pathology:
Mild petechial hemorrhage of the lungs was noted in two animals exposed to the AOS flake and one animal exposed to the spray-dried formulation

Any other information on results incl. tables

When administered as an aerosol with 90% active ingredient to rats for 1h the LC50 for C14 -C16 AOS is >229mg/L. Based on Haber's law this can be converted to an LC50 of >52mg/L for a 4h exposure to neat substance (see "Guidance on the Application of the CLP Criteria" p.194).

According to DSD and CLP the test substance does not have to be classified for inhalation toxicity.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
EU Directive 67/548/EEC: not classified
Regulation (EC) No 1272/2008: not classified