Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study performed without analytical measurements.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Vapour generated by an air-stream was passed through a inhalation chamber in which rats were exposed (whole body exposure) to the vapour stream for 4 hours. Observation was for 14 days post exposure.
GLP compliance:
no
Test type:
fixed concentration procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Araldite MY 720, TK 10884, batch-no. L-80028

Test animals

Species:
rat
Strain:
other: Charles River albino rats
Sex:
male/female
Details on test animals and environmental conditions:
Younf male and female rats (average weight 209 gm) were checked for health before entering the test. Animals were housed individually , and food and water was supplied ad libitum.

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
Exposure was in a 70l plexiglass chamber in which all rats were exposed by whole-body-exposure.
Cold air (-40°C) was passed through the test substance at a flow rate of 4.9 l/min, at a pressure of 29.92 inches of Hg at 25°C.
The average nominal vspour conc. was 30 mg/m3 air . This was the highest technically achievable concentration.
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
>= 4 h
Concentrations:
30 mg/m3 air (average)
No. of animals per sex per dose:
5 ales and 5 females
Control animals:
yes
Statistics:
no statistics was applied

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 30 mg/m³ air (nominal)
Exp. duration:
4 h
Remarks on result:
other: whole body exposure
Mortality:
no mortality occurred during the exposure and during the 14-day observation period.
Clinical signs:
no substance-related clinical signs were recorded.
Body weight:
body weight development was equal to that of the air control group.
Gross pathology:
Compared to the control group, a slight discoloration of the liver of all treated animals was observed.
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
relatively harmless
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
under the conditions of the test (30 mg/ MY720 per m3 air, for 4 hours) no signs of toxicity were recorded during the 14-day observation period.
The concentration used was the highest technically achievable concentration with this compound.
The LC50 is > 30 mg/m3 air as no mortality occurred and no adverse effects were noted.
Executive summary:

under the conditions of the test (30 mg/ MY720 per m3 air, for 4 hours) no signs of toxicity were recorded during the 14-day observation period. The concentration used was the highest technically achievable concentration with this compound. The LC50 is > 30 mg/m3 air as no mortality occurred and no adverse effects were noted.