3,3'-methylenebis[5-methyloxazolidine]

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Remarks:

Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Hannover, Germany

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Grotan® OX

IUPAC Name:

Grotan® OX

Details on test material:

- Name of test material (as cited in study report): Grotan® OX
- Substance type: Reaction product from paraformaldehyde and 2 hydroxypropylamine (ratio of 3:2)
- Physical state: Liquid
- Lot/batch No.: Ch B 9190

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

approx. 6-7 weeks of age at delivery, were purchased from Charles River Deutschland, Sulzfeld, Germany.

Administration / exposure

Route of administration:

inhalation: mixture of vapour and aerosol / mist

Type of inhalation exposure:

nose only

Vehicle:

clean air

Analytical verification of test atmosphere concentrations:

yes

Concentrations:

500 and 1000 mg/m3

No. of animals per sex per dose:

3m + 3f

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 1 000 mg/m³ air (nominal)

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

1 male died at 1000 mg/m3

Clinical signs:

other: All animals of group 2 (500 mg/m3) showed slight clinical signs like coat soiled, salivation, red stains around mouth directly after the end of exposure. During the next 4 hours only a soiled coat was observed. All animals of this group turned back to nor

Body weight:

Body weight was slightly decreased until day 3 in the male group 2 (500 mg/m3). In females of group 3 (1000 mg/m3) the body weight was markedly decreased until day 7 and returned to normal afterwards.

Gross pathology:

No findings were observed in males and females of the mid dose group (group 2).
In group 3 (1000 mg/m3) all animals showed findings in the lung (e.g. red areas, spongy consistency, partly dark red, and glassy areas). In one male of group 3 (1000 mg/m3), red areas in the thymus were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute inhalation toxicity of MBO following nose only exposure according to the OECD Guideline 436 the LD was >1000 mg/m3 in Wistar rats.
Based on the present study and according to the OECD Guideline 436, the test item will be classified under Category 4 of the Globally Harmonized System of Classification and Labelling of Chemicals (2003). The LC50 cut-off therefore is 2000 mg/m3 (2 mg/L).

Executive summary:

Six male and six female Wistar (WU) rats, approximately 9 weeks old at the day of exposure, purchased from Charles River Deutschland, Sulzfeld, Germany, were exposed for 4 hours to MBO at concentrations of 531 (group 2) or 1173 mg/m 3 (group 3). The temperature was 21.3° C and the relative humidity was between 61.2 (group 2) and 63.1 % (group3) during the exposure period.