Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Assume guideline study, no information on GLP. No information is available on the method.

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
1982

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: no information
Principles of method if other than guideline:
No information on method, as found in a secondary source reported to the U.S. Environmental Protection Agency. It is assumed that the method was according to a current guideline.
GLP compliance:
no
Test type:
other:
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Dodecenylsuccinic anhydride
EC Number:
246-917-1
EC Name:
Dodecenylsuccinic anhydride
Cas Number:
25377-73-5
IUPAC Name:
3-dodec-1-en-1-yldihydrofuran-2,5-dione
Test material form:
aerosol dispenser: not specified
Remarks:
migrated information: aerosol
Details on test material:
This material is associated with the CAS RN of the n-dodecenyl succinic anhydride, double-bond location unspecified. It is a larger set of n-dodecenyl succinic anhydrides to which the registered substance (with the double bond in the 2-carbon location from the succinic anhydride functional group) belongs.

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
The administered aerosol consisted of 90% dodecenyl succinic anhydride and 10% ethyl alcohol. No further information provided.

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
not specified
Vehicle:
not specified
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
4 h
Concentrations:
nominal chamber concentration - 5300 mg/m3, time-weighted measured concentration - 1220 mg/m3. The geometric mean particle size was 1.3 microns.
No. of animals per sex per dose:
No information
Control animals:
not specified
Details on study design:
This appears to be an acute inhalation assay, of 4 hours duration, with an observation period of 14 days. Survival is reported on day 15.
Statistics:
No information

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
5 300 mg/m³ air (nominal)
Based on:
not specified
Exp. duration:
15 d
Remarks on result:
other: equivalent to 5.3 mg/l as a mist
Mortality:
2/5 female rats died by the 2nd day post-exposure, and 2/5 male rats died by the 5th day post-exposure.
Clinical signs:
other: No information
Body weight:
No information
Gross pathology:
No information

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information The criteria for classification as Acute Toxicity Category 4 is ≤ 5.0 mg/L. Criteria used for interpretation of results: EU
Conclusions:
N-Dodecenyl succinic anhydride (nDDSA), as an aerosol, was tested in a four hour acute inhalation toxicity assay in rats. The LD50 was > 5.3 mg/L. This data suggests that nDDSA is not classified according to Regulation EC No. 1272/2008. Data can be read-across among members of the C8-12 Alkenyl Succinic Anhydrides Category, based on common functional groups, similar bread-down products and potency patterns among carbon-chain length. This is adequate to fulfill the information requirements, to be the basis for classification and labelling decisions, and for risk assessment.