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Description of key information

For assessment of the acute oral toxicity of the target substance, a weight of evidence approach was used.   Two studies on rats, and one on the mouse, gave an LD50 of 3.73 mL/kg, >33320 mg/kg and 41750 mg/kg respectively.  A further study on the analogue substance Nonanal, gave an LD50 of 5000 mg/kg.
For assessment of the acute oral toxicity of the target substance, a weight of evidence approach was also used. One study on the target substance gave an LD50 of 5.04 mg/kg. A further study on the analogue substance, Nonanal, gave an LD50 of > 5000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

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: Documentation insufficient for assessment.
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
Specific details on test material used for the study:
- Name of test material (as cited in study report): Aldehyde C-10 decyl (decanal)
- 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
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:
Excitation, diarrhoea, wet fur on stomach and posterior
Body weight:
No data
Gross pathology:
No data
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was assessed for acute oral toxicity using rats in a standard acute toxicity method. The acute oral LD₅₀ of the test substance to rats was >33320 mg/kg bw (the highest dose administered).
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: Documentation insufficient for assessment.
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
Specific details on test material used for the study:
- Name of test material (as cited in study report): Aldehyde C-10 decyl (decanal)
- 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
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:
Excitation, diarrhoea, wet fur on stomach and posterior
Body weight:
No data
Gross pathology:
No data
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was assessed for acute oral toxicity using mice in a standard acute toxicity method. The acute oral LD₅₀ of the test substance to mice was > 41.750 mg/kg bodyweight.
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: Documentation insufficient for assessment.
Qualifier:
no guideline followed
Principles of method if other than guideline:
Rats fed test material and observed for 14 d.
GLP compliance:
no
Remarks:
Study predates GLP
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): 1-Decanal (mixed isomers)
- Substance type: Aldehyde
- 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
Species:
rat
Strain:
other: Carwoth-Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: 4 to 5 wk
- Weight at study initiation: 90 to 120 g
- Fasting period before study:
- Housing: No data
- Diet (e.g. ad libitum): Rockland rat diet,
- 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
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
Dosages were arranged in logarithmic series differing by a factor of 2; (exact doses not specified)
No. of animals per sex per dose:
5 male per dose
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
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:
3.73 mL/kg bw
Based on:
test mat.
95% CL:
>= 2.43 - <= 5.74
Mortality:
No data
Clinical signs:
No data
Body weight:
No data
Gross pathology:
No data
Other findings:
No data
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was assessed for acute oral toxicity using rats in a standard acute toxicity method. The LD₅₀ of the test material in male rats was 3.73 mL/kg bodyweight.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
33 320 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint:
acute toxicity: inhalation
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:
no guideline followed
Principles of method if other than guideline:
Rats exposed to test substance in air for up to 8 hr and subsequently observed for 14 d.
GLP compliance:
no
Remarks:
study predates GLP
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): 1-Decanal (mixed isomers)
- Substance type: Aldehyde
- 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
Species:
rat
Strain:
other: Albino
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 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
Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE
- For exposure duration ≥ 0.25 hr, Vapour/air mixture was generated by passing 2.5 L of dried air at room temperature through a fritted glass disc immersed to a depth of 1 inch (2.54 cm) in approx. 50 mL of test chemical contained in a gas-washing bottle.
- For exposure duration ≤ 10 mins, static technique used, whereby 50 g to 100 g of substance were spread over a shallow tray 200 square inches (1290 cm²) is placed in a 120 L sealed chamber for ≥ 24 hr. Rats were then rapidly introduced by means of a drawer-type cage designed to minimise vapour loss.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
>= 0.033 - <= 8 h
Remarks on duration:
2 min, 5 min, 10 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, 8 hr
Concentrations:
1 concentration; doses dependent on exposure time
No. of animals per sex per dose:
6
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: clinical signs, body weight,organ weights, histopathology, other: No data
Sex:
male/female
Remarks on result:
other: No mortality was observed up to the highest exposure of 8 hr duration
Mortality:
0/6
Clinical signs:
other: No data
Body weight:
No data
Gross pathology:
No data
Conclusions:
The test substance was assessed for acute inhalation toxicity using exposure of rats to the test substance for up to 8 hours. No mortality was observed in the longest exposure period of 8 hours.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via dermal route

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Referenceopen allclose all

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:
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
Specific details on test material used for the study:
- Name of test material (as cited in study report): 1-Decanal (mixed isomers)
- Substance type: Aldehyde
- 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
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
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
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was assessed for acute dermal toxicity using New Zealand white rabbits in a standard acute method. The LD50 was 5.04 mL/kg bodyweight.
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:
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
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
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:
Severe oedema and burns
Body weight:
No data
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 bodyweight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
4 173 mg/kg bw

Additional information

Acute oral toxicity

For assessment of the acute oral toxicity of the target substance, a weight of evidence approach was used. Two studies on rats, and one on the mouse, gave an LD50 of 3.73 mL/kg, >3320 mg/kg and 41750 mg/kg respectively. A further study on the analogue substance Nonanal, gave an LD50 of 5000 mg/kg.

Acute inhalation toxicity

A study is presented that indicates low toxicity via the inhalation route. This is consistent with the low vapour pressure and lack of systemic effects in acute oral and dermal studies.

Acute dermal toxicity

A weight of evidence approach was also used to assess the acute dermal toxicity. A single study on the target substance indicated that the LD₅₀ of decanal was > 5.04 mL/kg bw (4173 mg/kg bw), however the study was of low reliability. Therefore read across data from an analogue substance, Nonanal, was also included, with an LD50 of > 5000 mg/kg bw. The available information supports the conclusion that the aldehydes, including Decanal, are not acutely toxic via the dermal route.


Justification for selection of acute toxicity – oral endpoint
Study on the test substance itself in an appropriate species.

Justification for selection of acute toxicity – dermal endpoint
Study performed on the test substance itself.

Justification for classification or non-classification

Based on the oral LD50 value of 33320 mg/kg and dermal LD50 value of 4173 mg/kg for the target substance and > 5000 mg/kg for the analogue substance, Nonanal, Decanal should not be classified for acute toxicity in accordance with the criteria outline in Annex VI of 67/548/EEC (DSD) and Annex I of 1272/2008/EC (CLP).