Nonanal

Endpoint summary

Description of key information

Acute oral toxicity weight of evidence approach was used.  One study performed on the target substance gave an LD50 of 5000 mg/kg bw.  Further studies on the analogue substance, decanal, gave an LD50 >33320 mg/kg bw in rats and 41750 mg/kg bw in mice.
Acute dermal toxicity weight of evidence approach was used.  One study performed on the target substance gave an LD50 of 5000 mg/kg bw.  Further studies on the analogue substances Octanal and Decanal gave LD50s of 6.85 mL/kg bw and 5.04 mL/kg bw respectively.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

No data

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Abstract only.

Qualifier:

according to guideline

Guideline:

other: Paragraph 191.1(f)(1) of the Final Order, Enforcement Regulations, United States Federal Register. Vol. 26, No. 155, p. 7336, 1961-08-12

GLP compliance:

no

Remarks:

Study predates GLP

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: Sherman-Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Fasting period before study: 24 hours
- Diet: Available ad libitum
- Water: Available ad libitum
- Acclimation period: 1 week

Route of administration:

oral: gavage

Vehicle:

not specified

Doses:

5000 mg/kg

No. of animals per sex per dose:

5 animals/sex

Control animals:

no

Details on study design:

Animals were observed for 14 days.

Statistics:

None

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities were observed.

Clinical signs:

other: Diuresis was noted soon after dosing followed by lethargy and dullness. Recovery was complete 24-48 hours after dosing.

Interpretation of results:

GHS criteria not met

Conclusions:

The test material was assessed for acute oral toxicity using rats exposed to the test material by oral gavage. The acute oral LD50 for the test material was >5000 mg/kg bw.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

No data

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study provides insufficient experimental detail and is therefore used as a weight of evidence.

Qualifier:

no guideline followed

Principles of method if other than guideline:

Groups of mice fed test material and observed for 14 d.

GLP compliance:

no

Remarks:

Study predates GLP

Test type:

standard acute method

Limit test:

no

Species:

mouse

Strain:

not specified

Sex:

male/female

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
- Housing: In cages
- Diet: Ad libitum
- Water: Ad libitum
- 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

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

No data

No. of animals per sex per dose:

5 male, 5 female per dose

Control animals:

no

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: clinical signs

Statistics:

LD₅₀ values were computed by the method of Litchfield & Wilcoxon (1949).

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 41 750 mg/kg bw

Based on:

test mat.

Mortality:

No

Clinical signs:

other: Excitation, diarrhoea, wet fur on stomach and posterior

Gross pathology:

No data

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral toxicity of the test substance was assessed in mice. The results determined that the acute oral LD₅₀ of decanal to mice was > 41,750 mg/kg bw.

Reference 3

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

No data

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study provides insufficient experimental detail and is therefore used as a weight of evidence.

Qualifier:

no guideline followed

Principles of method if other than guideline:

Groups of rats fed test material and observed for 14 d.

GLP compliance:

no

Remarks:

Study predates GLP

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Osborne-Mendel

Sex:

male/female

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: approx. 18 hr
- Housing: In cages
- Diet: Ad libitum (except fasting period)
- Water: Ad libitum
- 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

Route of administration:

oral: feed

Vehicle:

unchanged (no vehicle)

Doses:

No data

No. of animals per sex per dose:

5 male, 5 female per dose

Control animals:

no

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: clinical signs

Statistics:

LD₅₀ values were computed by the method of Litchfield & Wilcoxon (1949).

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 33 320 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Highest dose administered

Mortality:

No

Clinical signs:

other: Excitation, diarrhoea, wet fur on stomach and posterior

Gross pathology:

No data

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral toxicity of the test substance was assessed in rats. The results determined that the acute oral LD₅₀ of decanal to rats was >33320 mg/kg bw (the highest dose administered).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

No data

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Documentation insufficient for assessment

Qualifier:

according to guideline

Guideline:

other: Sedion 191.10 of the Final Order. Enforcement Regulations. United States Federal Register, Vol. 26, No. 155, p 7336 1961-08-12

GLP compliance:

no

Remarks:

study predates GLP

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

- Name of test material (as cited in study report): Aldehdyde C-9, EAO 71-14
- Substance type: No data
- Physical state: No data
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No.: No data
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: No data
- Other: Tested as supplied

Species:

rabbit

Strain:

other: Albino (probably New Zealand White)

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

Type of coverage:

not specified

Vehicle:

not specified

Details on dermal exposure:

TEST SITE
- Area of exposure: No data
- % coverage: No data
- Type of wrap if used: No data
- 3 rabbits' skin left intact; 3 rabbits' skin abraded.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data
- Time after start of exposure: No data

TEST MATERIAL
- Volume or weight applied: No data

Duration of exposure:

Single exposure

Doses:

5 g/kg bw

No. of animals per sex per dose:

6 animals (sex not specified) per single dose.

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: No data
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: No data

Statistics:

None

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

1/6 (1 rabbit from abraded group died on day 4)

Clinical signs:

other: Severe oedema and burns

Gross pathology:

No data

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance was assessed for acute dermal toxicity in albino rabbits. The LD50 was > 5000 mg/kg body weight.

Reference 2

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

No data

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study provides insufficient experimental detail and is therefore used as a weight of evidence.

Qualifier:

no guideline followed

Principles of method if other than guideline:

1 day cuff method of Draize et al.

GLP compliance:

no

Remarks:

study predates GLP

Test type:

standard acute method

Limit test:

no

Species:

rabbit

Strain:

New Zealand White

Sex:

male

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: 2.5 to 3.5 kg
- 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

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Fur removed from entire trunk by clipping
- Animals immobilised during 24 hr contact period

Duration of exposure:

24 hr contact period

Doses:

Maximum dose 20 mL/kg

No. of animals per sex per dose:

4

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 d

Statistics:

Based on the mortality during the 14 d period, the most probable LD₅₀ value and its fiducial range was estimated using the method of Thompson using the Tables of Wiel. The limits, where appropriate, were calculated as ± 1.96 standard deviations.

Sex:

male

Dose descriptor:

LD50

Effect level:

5.04 mL/kg bw

Based on:

test mat.

95% CL:

>= 3.78 - <= 6.82

Conclusions:

The test substance was assessed for acute dermal toxicity in albino rabbits. The LD50 was 5.04 mL/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Additional information

Acute oral toxicity

A weight of evidence approach was used for the assessment of the acute oral toxicity of the target substance. One study indicated the LD₅₀ of Nonanal was > 5000 mg/kg bw, however the study was of low reliability. Therefore data for two structural analogues, Octanal and Decanal were also presented. Further studies on the analogue substance, decanal, gave an LD50 >33320 mg/kg bw in rats and 41750 mg/kg bw in mice.The aldehydes are generally considered to be of low acute oral toxicity. 

Acute inhalation toxicity

Due to the low vapour pressure of this substance, and the lack of systemic toxicity found in acute oral or dermal toxicity studies, inhalation toxicity can be disregarded. Additionally, data from Smyth et al. (1962) are presented for structurally-related aldehydes, Octanal and Decanal, indicates no toxicity for this substance. No mortality was observed for either substance up to exposures of 8 hrs to test material saturated in air.

 

Acute dermal toxicity

A weight of evidence approach was used for the assessment of the acute dermal toxicity of the target substance. One study indicated the LD₅₀ of Nonanal was > 5000 mg/kg bw, however the study was of low reliability. Therefore data for two structural analogues, Octanal and Decanal were also presented, with LD50s of 6.85 mL/kg bw and 5.04 mL/kg bw respectively. All available information supports the conclusion that the aldehydes, including Nonanal, are not acutely toxic via the dermal route.

Justification for selection of acute toxicity – oral endpoint
Study on substance itself

Justification for selection of acute toxicity – dermal endpoint
Study on substance itself

Justification for classification or non-classification

Based on the oral LD50 values of >5000 mg/kg bodyweight and dermal LD50 values of > 5000 mg/kg bodyweight, there is no need to classify Nonanal for acute to toxicity in accordance with the criteria outlined in Annex VI of 67/548/EEC (DSD) and Annex I of 1272/2008/EC (CLP).