Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (limited documentation, no analytical determination of test atmosphere)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
adopted in 1981
Deviations:
yes
Remarks:
(limited documentation, no analytical determination of test atmosphere)
Principles of method if other than guideline:
Inhalation Hazard Test: Groups of 3 rats per sex are sequentially exposed to an atmosphere enriched with vapours of the volatile components of the test substance at 20 C° for 8 h.
GLP compliance:
no
Test type:
other: inhalation hazard test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Name of test substance (as cited in study report): 3-Methylpentanodiol-1,5
- Analytical purity: 99.5%
- Physical state: liquid
- Density: 0.973 g/mL

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: test group: 186 g; control group: 199 g
no additional details reported

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
Rats were exposed sequentially to the vapours generated by bubbling 200 L/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder for 8 h at 20 °C. The exposure was subsequently repeated in the same manner. No analytical determination of the atmosphere concentrations was performed. The nominal concentration was claculated as quotient of the amount of test substance weight loss during exposure, and the amount of air used during exposure. Group-wise documentation of clinical signs was performed over a 8 day study period.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
8 h
Concentrations:
0.07 mg/L (calculated as quotient of the amount of test substance weight loss and the amount of air used during the exposure)
No. of animals per sex per dose:
- Test group: 6
- Control group: 3
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of weighing: before exposure and at before sacrifice
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC0
Effect level:
0.07 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
8 h
Remarks on result:
other: No mortality and no clinical signs were observed when test animals were exposed to a test atmosphere presumably saturated with vapours of test substance at 20 °C.
Mortality:
No mortality was observed during the study.
Clinical signs:
other:
Body weight:
Test groups:
- day 0: 199 g (males), 173 g (females)
- day 7: 232 g (males), 187 g (females)

Control group:
- day 0: 205 g (males), 193 g (females)
- day 7: 237 g (males), 213 g (females)
Gross pathology:
No abnormalities detected.

Applicant's summary and conclusion

Conclusions:
No reliable conclusion can be made concerning classification for acute inhalative toxicity. However, because no mortality / clinical signs of toxicity was observed after 8 h exposure, and because of its very low vapour pressure, it can be conjectured that the test substance is unlikely to be toxic after acute inhalation (vapours).