Dimethyl(octyl)amine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

01.04.1980 to 02.08.1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non GLP, not all details on single animla data reported.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Remarks:

but quality assurance certificate

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dimethyl(octyl)amine

EC Number:

230-939-3

EC Name:

Dimethyl(octyl)amine

Cas Number:

7378-99-6

Molecular formula:

C10H23N

IUPAC Name:

dimethyl(octyl)amine

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): ADMA C8
- Physical state: clear liquid, specific gravity 0.76

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Nicholas Helf, Ace animals
- Age at study initiation: appr. 8 weeks
- Weight at study initiation: 2.3 to 2.8 kg
- Housing: Wire mesh cages 2 animals per cage
- Diet (e.g. ad libitum): fresh purina rabbit chow ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least one week
9 males, 7 females
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 21 deg. C


N-LIFE DATES: From: To:

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 200 cm2 (20% of body area)
- Type of wrap if used: guze patches wrapped with inpervious material.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): whiped (not washed) after 24 h exposure
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3.0 to 74 ml
- Constant volume or concentration used: no

Duration of exposure:

24 h

Doses:

1.0, 4.0, 16.0 and 20.0 g/kg bw

No. of animals per sex per dose:

4 animals per dose. Sexes were not equally distributed.

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days (or other?) 14 days
- Frequency of observations and weighing:
Dermal examinations at 24 h (Draize scoring), daily observations for signs of toxicity, behavior and mortality
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight at the start and the end of the study. All animals in the high dose group were examined for gross pathological changes as well as all animals that died durign the study.

Statistics:

Lichtfield Wilcoxon method for LD50 determination, 1949

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 4 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 1.500 to 10000 mg/kg bw

Mortality:

Dose Mortality
1 g/kg 0/4
4 g/kg 2/4
16 g/kg 4/4
20 g/kg 4/4

Clinical signs:

other: Skin reactions: Severe erythema and moderate oedema in all dose levels. the most common clinical sign was lethargy. Animals dying before day 14 had respiratory, cardiac and skin abnormalities.

Gross pathology:

Edematousl lungs i dilated heart n all animals of the high dose group, lun congestion and dilated heart in 4 animals of the 16 g/kg group. lung congestion in the two animals of the 4 g/kg bw group that died during the study.

Applicant's summary and conclusion

Interpretation of results:

sligthly toxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50, dermal rabbit was determined to be 4000 mg/kg bw. No deaths occurred at a dose level of 1000 mg/kg bw. Pronounced skin reactions, severe erythema and moderate edema were observed in all animals. Deaths occurred during the exposure period (day 0). According to the criteria of Regulation EC No. 1272/2008 and amendments the substance should not be classified for acute skin toxicity based on the results of this study.

Executive summary:

Groups of 4 rabbits received dermal doses of 1, 4, 16 or 20g of test material per kg of body weights for a 24 h occlusive exposure period. Test material was wiped from the skin after the dosing period. The animals were observed for 14 days. The LD50 was determined to be 4000 mg/kg bw. Deaths occurred during the exposure period. According to the criteria of Regulation EC No. 1272/2008 and amendments the substance should not be classified for acute skin toxicity.