Heptanal

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: 2d Test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

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:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Heptanal

EC Number:

203-898-4

EC Name:

Heptanal

Cas Number:

111-71-7

Molecular formula:

C7H14O

IUPAC Name:

heptanal

Details on test material:

- Name of test material (as cited in study report): heptanal
- Substance type: aldehyde
- Physical state: no data
- Analytical purity: 98-99 %
- Purity test date: no data
- Lot/batch No.: 810319
- Expiration date of the lot/batch: no data
- Stability under test conditions: the test substance was judged to be stable for the duration of the study.
- Storage condition of test material: in the dark at ambient temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Shell Toxicology Laboratory (Tunstall)
- Age at study initiation: 10 weeks
- Weight at study initiation: males 251-328 g; females 180 - 220 g
- Fasting period before study: no data
- Housing: individually
- Diet : ad libitum (PRD, Labsure Animal Foods Ltd.)
- Water : ad libitum (filtered but untreated water from the public supply)
- Acclimation period: Rats were bred in the Shell Toxicology Laboratory.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 20
- Humidity (%): 58-70
- Air changes (per hr): no data
- Photoperiod : 12 hrs dark / 12 hrs light


IN-LIFE DATES: no data

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: two tubular glass chambers
- Exposure chamber volume: 7 l
- Method of holding animals in test chamber: no data
- Source and rate of air: The test atmosphere was supplied at a minimal flow rate of 10 litres per minute
- Method of conditioning air: no data
- System of generating particulates/aerosols: the test atmosphere was generated by passing 3 to 4 l min -1 of nitrogen through a wick type saturator maintained at 78°C in a thermostated water bath. The vapou/air mixture was diluted with air at a flow rate of approximately 16 l min -1 before delivery to two identical, glass inhalation chambers each of volume 7 litres.
- Treatment of exhaust air: no data
- Temperature, humidity, pressure in air chamber: no data


TEST ATMOSPHERE
- Brief description of analytical method used: The concentration of the heptanal in the test atmosphere was measured continuously throughout the exposure by means of a Miran infra-red gas analyser. The latter was calibrated by injecting known volumes of heptanal into a closed loop circulating system also of known volume including the analyser gas cell.
- Samples taken from breathing zone: no

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

18.4 mg/l

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for toxic signs at frequent intervals throughout the exposure. Afterwards animals were observed daily for toxic signs over the following 14 days. Body weights were recorded initially and after 7 and 14 days.
- Necropsy of survivors performed: no
- Other examinations performed: no data

Statistics:

Studen's t test was used to compare body weight between treated and control animals.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC0

Effect level:

> 18.4 mg/L air

Exp. duration:

4 h

Remarks on result:

other: Exposure concentration was near saturated

Mortality:

The one male rat that died within 5 minutes of the cessation of exposure was examined histopathologically. Since no other rats died or showed any macroscopic abnormalities at necropsy, it was concluded that the single death was not directly related to exposure.

Clinical signs:

other: Signs of intoxication that persited throughout the exposure period included rapid respiration, eye and nasal irritation, salivation and a general state of agitation. The female rats recovered within 48 hours, however some of the signs persisted in the mal

Body weight:

Body weights of the exposed group of animals increased normally during the observation period and mean body weights of the test and control groups were not significantly different (Studen's t test)

Gross pathology:

No data

Other findings:

No data

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: EU and CLP classification

Conclusions:

Under the conditions of this test, no mortality was directly related to the exposure.

Executive summary:

In an acute inhalation toxicity study (Shell, 1982), a group of 5 male and 5 female rats was exposed for 4 hours to a mean concentration of 18.4 mg/l of heptanal a near saturated atmosphere. Signs of intoxication that persited throughout the exposure period included rapid respiration, eye and nasal irritation, salivation and a general state of agitation. The female rats recovered within 48 hours, however some of the signs persisted in the male rats for the whole of the 14 day post exposure period. Body weights of the exposed group of animals increased normally during the observation period and mean body weights of the test and control groups were not significantly different (Studen's t test). The one male rat that died within 5 minutes of the cessation of exposure was examined histopathologically. Since no other rats died or showed any macroscopic abnormalities at necropsy, it was concluded that the single death was not directly related to exposure. Then, the acute 4 h inhalation LC50 (and LC0) of heptanal in Wistar rats is greater than 18.4 mg/l a concentration which is near saturated.