Heptan-1-ol

Endpoint summary

Description of key information

There are an acute oral and dermal toxicity study performed in rats and rabbits, respectively (R. Truhaut, 1974). An acute inhalation study in rats was perfomed. The studies designs were comparable to respective guideline studies.
LD50 oral (rats) : approx 5500 mg/kg
LD50 dermal (rabbits) >2000 mg/kg
LC0 (rats)=7.4 mg/m3

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)

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Strain= wistar
Weight =males (approx. 250g) and females (approx. 200g)

Route of administration:

oral: gavage

Vehicle:

olive oil

Doses:

2500, 3500, 4100, 6150, 8200, 10250, 12300 mg/kg

No. of animals per sex per dose:

10 animals/sex/group

Control animals:

no

Details on study design:

After administration of the test item, the animals were submitted to a 2-weeks observation period and the mortality rate and clinical signs were recorded. Post-mortem examination was performed.

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 6 200 mg/kg bw

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 5 500 mg/kg bw

Mortality:

Generally death appeared during the first 48 hours after dosing. No animals were found dead after the sixth days of dosing.
2500 mg/kg: no death.
3500 mg/kg : 1/10 males dead and 1/10 females dead,
4100 mg/kg: 2/10 males dead and 3/10 females dead,
6150 mg/kg : 6/10 females dead
8200 mg/kg: 3/10 females dead and 7/10 females dead,
10250 mg/kg: 8/10 males dead
12300 mg/kg: 9/10 males dead and 10/10 females dead.

Clinical signs:

other: Lung edema were observed in death animals at post-mortem examination.

Gross pathology:

Symptoms of acute lung edema were observed in the dead animals.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: Directive EC No. 1272/2008

Conclusions:

The oral LD50 of Heptanol was 6200 +/- 700 mg/kg for males rats and 5500 +/- 500 mg/kg for the females.

Executive summary:

The acute oral toxicity study was evaluated in rats for n-heptanol-1. The acute toxicity was considered low for each of the males and the females. During the necropsy examinaqtion, signs of irritation were recorded for the lung parenchyma for the male rat. Indeed, acute edema of the lung was recorded for the animals found dead few hours after test item administration, this was substantiated by inflamation of the lung alveolar and hemosiderin deposits.In the males rats, congestion and inflammation of the lung were associated with lesions in the lungs but the incidence was not dose-related. In the females rats, kidney dilatation was observed at the highest dose-levels. No other effects were observed on the sampled organs.

Endpoint conclusion

Dose descriptor:

LD50

Value:

5 500 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Dose descriptor:

discriminating conc.

Value:

7.4 mg/m³ air

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: guideline comparable to OECD 402

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Principles of method if other than guideline:

Draize et al., J pharmacol exp thera, 19477, 82, 377-390.

GLP compliance:

no

Test type:

other: Draize et al 1944

Limit test:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Rabbits were shaved on both the left and right side and also on the back, The skin exposure surface was therefore estimated between 200 cm2 to 350-400 cm2.

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

exposure surface= 250 to 350-400 cm2.

Duration of exposure:

2 weeks

Doses:

40 ml (1.3 g/kg) and 50 ml (2.7 g/kg)

No. of animals per sex per dose:

6 animals/dose

Control animals:

no

Details on study design:

50 ml of test item was administered on the skin surface. Animals were shaved on the back and the left and right sides. The dose-levels of 25 ml (20.5 g) , 40 ml ( 32.8g) and 50 ml (41.0g) were administrated by the cutaneous route. Half of the animals were sacrificed 2 weeks after the fisrt exposure and and the other half 6 weeks after. Major organs were sampled for histopathlogical examination.

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

25 ml (20.5 g equivalent 7.32 g/kg): no absorption, no mortality
40 ml(32.8g equivalent 11.7 g/kg): 1.3 g/kg interna dose: 2/6 dead animals
50 ml (41g equivalent 14.6 g/kg) : 2.7 g/kg internal dose: 4/6 dead animals.

Clinical signs:

other: At the absorbed dose-levels of 1.3 and 2.7 g/kg,tThe skin presented severe escars and sometimes suppurative lesions.

Gross pathology:

The results from histopathological examination revealed no alteration of the lung, the heart, liver, kidney, testes, pancreas and spleen. The brain presented spongiosis which was more severe in animals after 6 weeks exposure. The skin presented severe lesions of the derm with deep inflamatory infiltation.

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The LD50 of n-heptanol 1 is higher than 2000 mg/kg

Executive summary:

The acute dermal toxicity of n-heptanol was evaluated in rabbits according to a comparable draize method. The test item was applied to the skin of rabbits (6 animals/dose) at the dose-levels of 20.5, 32.8 and 41.0 g/ animal for 24 hours. Animals were then observed during 14 days for mortality, clinical signs, effects on body weight. Half of the rats were necropsied after 2 weeks and the other half after 6 weeks. 2/6 animals died at the dose-level of 32.8 g/animal (approx 11.7 g/kg) and 4/6 animals died at 2.7 g/animal (equivalent 14.6 g/kg). Lesions of the skin (caustic) and the brain were recorded at histopathological examination.

The LD 50 by dermal route was higher than 2 g/kg.

Endpoint conclusion

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Additional information

Acute oral toxicity (R, Truhaut, 1974)

The acute oral toxicity study was evaluated in rats for n-heptanol-1. The acute toxicity was considered low for each of the males and the females. During the necropsy examinaqtion, signs of irritation were recorded for the lung parenchyma for the male rat. Indeed, acute edema of the lung was recorded for the animals found dead few hours after test item administration, this was substantiated by inflamation of the lung alveolar and hemosiderin deposits. In the males rats, congestion and inflammation of the lung were associated with lesions in the lungs but the incidence was not dose-related. In the females rats, kidney dilatation was observed at the highest dose-levels. No other effects were observed on the sampled organs.

Acute inhalation toxicity (R. Truhaut, 1974)

The test item, n-heptanol-1 was exposed by inhalatation to 10 males and 10 females rats at the maximum saturated concentration via asingle whole body inhlation exposure during 4 hours. Animals were submitted to a 2 week observation period.

No mortality was recorded in any animal. No signs of narcosis were observed nor abnormal behaviour. The histopathological examination of the sample organs (brain, lung, heart, liver, pancreas, bladder, kidneys, ovaries and testes) has revealed no treatement related changes. At the maximum vapour saturated concentration, no mortality was recorded after a single exposure during 4 hours. The LC0 was estimated at 7.4 mg/m3.

Acute dermal toxicity (R. Truhaut, 1974)

The acute dermal toxicity of n-heptanol was evaluated in rabbits . The test item was applied to the skin of rabbits (6 animals/dose) at the dose-levels of 20.5, 32.8 and 41.0 g/ animal for 24 hours. Animals were then observed during 14 days for mortality, clinical signs, effects on body weight. Half of the rats were necropsied after 2 weeks and the other half after 6 weeks. 2/6 animals died at the dose-level of 32.8 g/animal (approx 11.7 g/kg) and 4/6 animals died at 2.7 g/animal (equivalent 14.6 g/kg). Lesions of the skin (caustic) and the brain were recorded at histopathological examination.

The LD 50 by dermal route was higher than 2 g/kg.

Justification for classification or non-classification

According to REGULATION (EC) No 1272-2008:

Acute oral toxicity:

LD 50 > 5500 mg/kg. Not classified

Acute inhalation toxicity:

No mortality was recorded at the maximum saturated dose. The approximated calculated LC0 was set at 7.4 mg/m3 (7455 mg/l). No classification is warranted based on the available data.

Acute dermal toxicity:

No classification is warranted based on the available data. LD50>2000 mg/kg.