Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 433 draft (Acute Inhalation Toxicity: Fixed Concentration Procedure) (not officially approved)
GLP compliance:
yes
Test type:
fixed concentration procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
As per IUCLID5 Sections 1.1. - 1.4.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Sprague-Dawley rats 6 to 8 weeks of age were acquired from Charles River UK Limited, Margate, Kent. the animals were housed in polyproylene cages and allowed free access to feed (Labsure LAD 1) and tap water. The animal holding room temperature was 18 - 24 degrees C and the relatuve humidity was 35 - 65% during the study.

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
The rats were exposed continously by whole body in inhalation chambers for 4 hr to the test atmosphere containing vapor and droplets of the test substance. A vapor generator was used to supply test substance to the inhalation chamber. 1,6-Hexanediol Diglycidylether (HDDGE) was supplied to the vapor generator by means of a syringe driven by a syringe pump. Clean dried air at approximately 50 C was supplied under pressure to the vapor generator at a flow rate of approximately 25 liters per minute. The animals were exposed to this vapor of HDDGE for 4 hr and then returned to eteir cages. Test substance concentration was monitored by withdrawing five samples from the inhalation chamber followed by GC analysis.
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
0.035 mg/L
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
Five animals of each sex were exposed to a concentration of 1,6-Hexanediol Diglycidylether (HDDGE) of approximately 35 mg/m3 (3.7 ppm) for 4 hr. The control group was exposed to air only. The animals were observed continously during exposure for clinical signs and at least twice daily during the 14-day observation period. Body weights were taken daily and feed and water consumption calculated on a daily basis. Following sacrifice, the animals were subjected to a detailed macroscopic examination. The lungs were removed, dissected free of surronding tissue and weighted.
Statistics:
No data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
other: NOEC
Effect level:
0.035 mg/L air (analytical)
Exp. duration:
4 h
Mortality:
There were no deaths during the study.
Clinical signs:
other: No abnormalities.
Body weight:
No adverse effects of exposure.
Gross pathology:
No abnormalities that were considered to be of toxicological significance.

Any other information on results incl. tables

Sample

Time

Concentration in air (mg/L)

2.1

2.2

2.3

2.4

2.5

0h : 30m

1h : 00m

2h : 00m

3h : 00m

3h : 45m

0.042

0.036

0.027

0.026

0.044

Mean

0.035

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The highest attainable concentration of HDDGE, 0.035 mg/l of air (3.7 ppm), was not toxic to rats after a single, 4-hour, whole-body exposure.
Executive summary:

1,6-Hexanediol Diglycidylether (HDDGE) was accessed for acute inhalation toxicity potential by an O.E.C.D. 433 Testing Guideline study conducted with GLP compliance. The animals were exposed by whole body inhalation to primarily vapor phase HDDGE. The highest attainable concentration of HDDGE, 0.035 mg/l of air (3.7 ppm), induced no mortalities and was not toxic to rats after a single, 4-hour, whole-body exposure.