Dodecanal

Acute Toxicity: dermal

Administrative data

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.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

Dodecanal

EC Number:

203-983-6

EC Name:

Dodecanal

Cas Number:

112-54-9

Molecular formula:

C12H24O

IUPAC Name:

dodecanal

Constituent 2

Reference substance name:

RIFM-K1188

IUPAC Name:

RIFM-K1188

Details on test material:

- Name of test material (as cited in study report): RIFM-K-1188
- 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

Test animals

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

Administration / exposure

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.

Results and discussion

Effect levels

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.

Applicant's summary and conclusion

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.