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Administrative data

Description of key information

Inhalation: LC50 > 18.6 mg/l for female and male rats (similar to OECD Guideline 403).
Oral: LD50 > 5000 mg/kg bw (similar to OECD Guideline 401).
Dermal: no reliable study is available.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This acute oral study is classified as reliable with restriction considering that the report is very succinct.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Fasting period before study: no data
- Housing:no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum):no data
- Acclimation period: no data


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


IN-LIFE DATES: no data
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
No data
Doses:
5 g/kg
No. of animals per sex per dose:
10 (no information on sex)
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data
- Other examinations performed: no data
Statistics:
No statistics were performed.
Preliminary study:
Not concerned.
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Sex:
not specified
Dose descriptor:
LD0
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortality was observed.
Clinical signs:
other: Lethargy and piloerection were reported.
Gross pathology:
no data
Other findings:
None
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: EU and CLP classifications
Conclusions:
Under the conditions of this test, Heptanal did not induce any mortality among the animals at the tested dose level of 5000 mg/kg.
Executive summary:

In an acute oral toxicity study, 10 rats were given a single oral dose of heptanal at a dose level of 5000 mg/kg bw and observed for 14 days. No death occurred during the course of the study. Lethargy and piloerection were the only clinical signs reported. LD0 = 5000 mg /kg bw in rats.

Under the conditions of this test, heptanal is therefore not classified according to EU and GHS classifications.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
5 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
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
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
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
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.
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
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating conc.
Value:
18.6 mg/m³ air

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute oral toxicity:

In an acute toxicity study (Moreno, 1974), rats were administered a single oral dose of heptanal at 5000 mg/kg bw and observed for 14 days. No deaths were reported. Lethargy and piloerection were the only signs reported. The oral LD50 value was greater than 5000 mg/kg bw.

Acute inhalation toxicity:

Several data are available for this endpoint.

In the key study (Blair, 1982), a group of 5 male and 5 female rats were exposed for 4h to near saturated atmosphere of heptanal. Since no deaths occurred, the acute 4 h inhalation LC50 of heptanal in Wistar rats is greater than 18.4 mg/l, a concentration which is near saturated.

In the Hoffman supporting study (1989), 3 male and 3 female rats were exposed to heptanal vapor for a single four hour inhalation exposure at a measured concentration of 4.7 mg/l. Signs indicating irritation of the respiratory tract were observed during the exposure, but reversed quickly after the exposure ended. No mortality, signs of toxicity, or body weight changes were observed during a one week observation period. In another supporting study (Eschbach, 1981), four hour inhalation exposures of rats to measured aerosol concentrations of 0.23 and 0.52 mg/l did not produce mortality. Both concentrations caused body weight losses in all animals which did not recover until the second week post-exposure. Signs of respiratory and eye irritation of approximately equal incidence were observed in both groups. Eye effects included corneal opacities which increased or persisted during the 14 day post-exposure period.

In conclusion, heptanal has a low acute systemic toxicity following single exposure by inhalation.

Acute dermal toxicity:

No reliable data.

Justification for classification or non-classification

Based on these data, Heptanal is not classified for acute toxicity according to EU regulation (EC) No 1272/2008 (CLP), respectively.

Acute oral: not classified (LD50 > 5000 mg/kg; no mortality was observed)

Acute inhalation: not classified but data are inconclusive (LC50 > 18.4 mg/l; no death due to test material administration was observed; 18.4 mg/l is the satured concentration therefore no other study with higher concentration is possible).

Acute dermal: not classified because data lacking.

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