2,3-epoxypropyltrimethylammonium chloride

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

other: EU Risk Assessment

Adequacy of study:

other information

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Although the EU risk assessment report is secondary literature, all data and risk assessment for the human, health and the environment have been evaluated and reviewed by Finland prior to publication. The risk assessment report has been submitted to final approval and published in the Official Journal of the European Union C157/10 dated on 21.06.2008. Thus, it is considered the information reported are reliable with the restrictions that reliability of the data presented has not been assessed again.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

publication

Title:

European Union Risk Assessment 2,3-epoxypropyltrimethylammonium chloride CAS RN 3033-77-0 Einecs No: 221-221-0

Author:

EC

Year:

2008

Bibliographic source:

Risk Assessment. Final approved version. Rapporteur: Finland (FIN). European communities. Printed in Italy. 147pp

Materials and methods

Principles of method if other than guideline:

No details

GLP compliance:

not specified

Test type:

other: no data

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,3-epoxypropyltrimethylammonium chloride

EC Number:

221-221-0

EC Name:

2,3-epoxypropyltrimethylammonium chloride

Cas Number:

3033-77-0

Molecular formula:

C6H14NO.Cl

IUPAC Name:

N,N,N-trimethyl(oxiran-2-yl)methanaminium chloride

Details on test material:

No detail

Test animals

Species:

rat

Strain:

not specified

Sex:

female

Details on test animals or test system and environmental conditions:

No detail

Administration / exposure

Route of administration:

other: assumption of an exposure to EPTAC aerosol

Type of inhalation exposure:

not specified

Vehicle:

not specified

Details on inhalation exposure:

no detail

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

7 h

Concentrations:

Nominal concentration: 8.17 mg/L

No. of animals per sex per dose:

assumed 4 female rats

Control animals:

not specified

Details on study design:

no detail

Statistics:

no data

Results and discussion

Preliminary study:

no data

Effect levels

Sex:

female

Dose descriptor:

LC50

Effect level:

8.17 mg/L air (nominal)

Based on:

test mat.

Remarks on result:

other: for a 7 hours inhalation exposure

Mortality:

no mortality occured at 8.17 mg/L EPTAC

Clinical signs:

other: the only observed effect was irritation to the eyes.

Body weight:

no data

Gross pathology:

no data

Other findings:

no other findings

Any other information on results incl. tables

no other information

Applicant's summary and conclusion

Interpretation of results:

other: not conclusive

Conclusions:

Due to the study quality, no definite conclusion can be drawn for the acute toxicity via inhalation route.

Executive summary:

According to a test performed by Dow (1984) a 7-hour inhalation exposure at a nominal concentration of 8.17 mg/L 2,3-Epoxypropyltrimetylammonium Chloride (EPTAC) caused no lethality or systemic effects in 4 female rats. The only observed effect was irritation to the eyes. No properly conducted test to obtain a 4-hr LC₅₀value is available. It can be hypothesized that the 4-hr LC₅₀value is above 5 mg/L, which is the limit classification for an acute inhalation of dust or mist. However, due to the study quality, no definite conclusion can be drawn for the acute toxicity via inhalation route.