Alcohols, C8-10-iso-, C9-rich

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:

other: Acceptable, well-documented study report equivalent or similar to OECD guideline 403: pre-GLP.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1968

Report date:

1968

Reference 2

Reference Type:

publication

Title:

Unnamed

Year:

1973

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

fixed concentration procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Substance type: Commercial product
-Molecular weight: 144.25

Test animals

Species:

other: mice, rats, guinea pigs

Strain:

not specified

Sex:

male

Details on test animals or test system and environmental conditions:

No data provided.

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Plexiglas chamber
- Exposure chamber volume: 1000 L
- Source and rate of air: Infusion pump
- System of generating particulates/aerosols: Positive pressure spray nozzle
- Airflow: 63 lpm

Analytical verification of test atmosphere concentrations:

no

Remarks:

Nominal concentraion calculated

Duration of exposure:

ca. 6 h

Concentrations:

Nominal concentration of 21.7 mg/l

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: Daily for 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Statistics:

No data analyzed.

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LC50

Effect level:

> 21.7 mg/L air (nominal)

Exp. duration:

6 h

Mortality:

2 rats and 1 mouse succumbed within 14 hours of the termination of the study

Clinical signs:

other: All animals became restlessness upon administration of the test material. Dyspnea was noted in several mice. Shallow respiration, closed eyes, and lowered heads were noted in the rats after 20 minutes of exposure and persisted for the duration of the ex

Body weight:

Not measured

Gross pathology:

The lungs in one rat were adhered to the rib cage and the diaphragm was darker red in color than normal and contained extremely dark red-purple firm areas. One lobe had a firm consistency and was light purple in color. The lungs of the second rat were red with several dark purple areas. Both rats had dark purple livers and dark kidney medullae. The only abnormalities seen in the mouse was a dark medulla and dark kidney pelvis.

Other findings:

Gross necropsies performed at the termination of the observation period revealed no abnormalities in 4 mice and 2 guinea pigs. Abnormalities seen in the lungs were tan-gray spots, tan-gray area, white spots, areas of consolidation, gray-purple areas, dark red areas, and an irregular surface. Abnormalities were also noted in the livers of the animals and consisted of areas of discoloration.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute inhalation LC50 for isononanol is >21.7 mg/l.

Executive summary:

Isononanol was administered via a vapor inhalation to 10 each of mice, rats, and guinea pigs at the nominal concentration of 21.7 mg/l for 6 hours.   During the exposure, signs of irritation observed included transient restlessness followed by extreme inactivity, eye irritation, and shallow respiration.  Swelling of the rims of the eyes, hyperemia of the ears, and a red-brown encrustation around the nose were noted when the animals were returned to group housing.  In addition, three rats and two mice were in a state of collapse.  Two rats and one mouse succumbed within 14 hours of the termination of the study.  Gross necropsy findings included discolored lungs and livers in the animals.   At the end of the study, the LC50 was >21.7 mg/l for each species.