Dodecanal

Endpoint summary

Description of key information

The test substance was assessed for acute oral toxicity in rats.  Under the conditions of the test, the test substance had an LD50 of 23100 mg/kg bw.
The test substance was assessed for acute dermal toxicity in rabbits.  The test substance had an LD50 > 2000 mg/kg bw.

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

Study period:

No data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards with acceptable restrictions.

Qualifier:

no guideline followed

Principles of method if other than guideline:

Rats fed three dose levels of test material and observed for 14 d for mortality

GLP compliance:

no

Remarks:

study predates GLP

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

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: 150 g to 208 g
- Fasting period before study: 16 hrs
- Housing: Stock cages prior to dosing, individually in wire-mesh cages after dosing.
- Diet: Standard laboratory diet, ad libitum
- Water: Ad libitum
- Acclimation period: 5 d

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:

10.2 g/kg bw, 15.4 g/kg bw, 23.1 g/kg bw

No. of animals per sex per dose:

2 animals per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Initial and final body weights recorded
- Animals sacrificed after 14 d.
- Necropsy of all animals performed.

Statistics:

LD50s were calculated using the techniques of Weil, Thompson, and Thompson and Weil.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

23 100 mg/kg bw

Based on:

test mat.

Mortality:

Both females in the highest group died, 12-F at 12 d, 11-F at 13 d.

Clinical signs:

other: 10.2 g/kg bw dose: Hypoactivity beginning 30 min following dose administration and which lasted 2 days, ruffed fur beginning 1 h following dose administration and which lasted 1 day. 15.4 g/kg bw dose: Hypoactivity beginning 30 min following dose admini

Gross pathology:

- Necropsy of animals that died revealed haemorrhages of the stomach.
- Haemorrhages were also observed in animal 10-M (23.1 g/kg bw dose level).
- No other gross pathological alterations were noted.

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Conclusions:

The test substance was assessed for acute oral toxicity in rats. Under the conditions of the test, the test substance had an LD50 of 23100 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

23 100 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

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

Study period:

No data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards with acceptable restrictions.

Qualifier:

no guideline followed

Principles of method if other than guideline:

Test material applied to skin of 4 rabbits for 24 hrs at a dose of 2000 mg/kg bw; rabbits then observed for 14 d, necropsied.

GLP compliance:

no

Remarks:

Study predates GLP

Test type:

standard acute method

Limit test:

yes

Species:

rabbit

Strain:

New Zealand White

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: 2.50-3.10 kg
- Fasting period before study: No
- Housing: Individually in hanging rabbit cages
- Diet: Standard laboratory rabbit ration, ad libitum
- Water: Ad libitum
- Acclimation period: ≥ 7 d

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
- Area of exposure: Back
- Type of wrap if used: Plastic

REMOVAL OF TEST SUBSTANCE
- Washing.
- Time after start of exposure: 24 hrs

Duration of exposure:

24 hrs

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

2 male, 2 female per the single dose.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily
- Necropsy of survivors performed.
- Other examinations performed: Clinical signs.

Statistics:

LD₅₀ was calculated.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

0/4

Clinical signs:

other: No behavioural reactions were exhibited by any of the animals.

Gross pathology:

No gross pathological alterations were noted.

Other findings:

- Other observations: Skin reaction; definite red erythema and mild oedema of the skin were noted after 24 hrs of contact. After 6 d, superficial escharosis was evident. By the end of the 14 d observation period, the skin had begun to slough.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance was assessed for acute dermal toxicity in rabbits. The test substance had an LD50 > 2000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Acute oral toxicity

The test substance was assessed for acute oral toxicity in rats. In the high dosage group both females died at 12 and 13 days following administration of the test substance; necropsy revealed haemorrhages of the stomach. Haemorrhages of the stomach were also observed in one male in the 23.1 g/kg bw dose level. No other gross pathological alterations were noted. Clinical signs noted were hypoactivity, ruffed fur, muscular weakness and emaciation. Under the conditions of the test, the test substance had an LD50 of 23100 mg/kg bw.

 

Acute inhalation

No study available.

 

Acute dermal toxicity

The test substance was assessed for acute dermal toxicity in rabbits. There was no mortality during the test and no behavioural reactions were exhibited by any of the animals. No gross pathological alterations were noted. Signs of dermal irritation were noted, however including definite red erythema and mild oedema of the skin after 24 hrs of contact. After 6 d, superficial escharosis was evident. By the end of the 14 d observation period, the skin had begun to slough. The test substance had an LD50 > 2000 mg/kg bw.

Justification for classification or non-classification

Based on the acute oral LD50 values of 23100 mg/kg bodyweight and the acute dermal value of 2000 mg/kg bodyweight the test substance does not need to be classified according to the criteria outlined in Annex VI of 67/548/EEC (DSD) and Annex I of 1272/2008/EC (CLP).