2-Octen-1-ylsuccinic anhydride, mixture of cis and trans

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

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:

publication

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

Test material information

Constituent 1

Reference substance name:

Dodecenylsuccinic anhydride

EC Number:

246-917-1

EC Name:

Dodecenylsuccinic anhydride

Cas Number:

25377-73-5

Molecular formula:

C16H26O3

IUPAC Name:

3-dodec-1-en-1-yldihydrofuran-2,5-dione

Constituent 2

Reference substance name:

dodecenyl succinic anhydride

IUPAC Name:

dodecenyl succinic anhydride

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) 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:

GHS criteria not met

Conclusions:

A category member, 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.