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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.