Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June 11 - July 5, 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Physical Description: Colourless to yellow liquid
Solubility: Soluble in water.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
nose only
Vehicle:
air
Details on inhalation exposure:
Air Supply: Filtered air was supplied by an air compressor (Powerex Model: SES05) to the spray atomization nozzle. Additional compressed mixing air supplied from the air compressor was introduced into the chamber to help uniformly distribute the test atmosphere by creating a vortex at the chamber inlet. Compressed airflow was measured with a Mass Flowmeter. Chamber airflow was monitored throughout the exposure period and recorded periodically
Duration of exposure:
< 4 h
Concentrations:
After establishing the desired generation procedures during pre-test trials, twenty healthy rats were selected for test and equally distributed (5 per sex/group) into two exposure levels. Exposure levels of 1.0 and 5.0 mg/L were selected for testing.
No. of animals per sex per dose:
10 Males and 10 Females. The females assigned to test were nulliparous and non-pregnant.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 1.04 - < 5.12 mg/L air
Based on:
test mat.
Exp. duration:
4 h

Any other information on results incl. tables

1.04 mg/L

The gravimetric and nominal chamber concentrations were 1.04 and 10.95 mg/L respectively. The mass median aerodynamic diameter was calculated to be 1.94 μm based on graphic analysis of the particle size distribution as measured with an ACFM Andersen Ambient Particle Sizing Sampler.

All animals survived exposure to the test atmosphere. Following exposure, all rats exhibited abnormal respiration. In addition, two males and one female showed signs of abdominal distention and/or ano-genital staining and reduced fecal volume. Ocular and nasal discharge and facial staining were also noted for this female. All five males and four female recovered from the above symptoms by Day 6. Although all rats lost body weight by Day 1 and/or through Day 3, all animals showed a weight gain over the course of the 14 day study. Apart from irregular respiration persisting through Day 14, the fifth female recovered from all other symptoms by Day 12 and showed improved health through weight gain by study termination (Day 14). No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.

5.12 mg/L

The gravimetric and nominal chamber concentrations were 5.12 and 99.61 mg/L respectively. The mass median aerodynamic diameter was calculated to be 2.36 μm based on graphic analysis of the particle size distribution as measured with an ACFM Andersen Ambient Particle Sizing Sampler.

Following exposure to the test atmosphere, all rats exhibited clinical signs including abnormal respiration, hypoactivity, nasal and ocular discharge, ano-genital staining, tremors and/or an unthrifty appearance. One female was found dead on Day 1, three males and a second female died on Day 2 and a third female died by Day 3. The fifth male showed signs of opacity in one eye, a

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
Migrated information
Conclusions:
Under the conditions of this study, the single exposure acute inhalation LC50 of the test substance is between 1.04 mg/L and 5.12 mg/L in male and female rats. Based on the results of this study, Formaldehyde, reaction product with ethylenediamine is assigned EC classification of risk phrase R-20 Harmful and meets the requirements of GHS Toxicity Category 4.