Dimethyl(octyl)amine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

04/01/1980-08/02/1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

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)

Version / remarks:

Study conducted before OECD 402 was in existence. The LD 50 was calculated according to the method of Litchfield
J.T. Jr. & F. Wilcoxon (J. Pharm. & Exp. Therap. 96:99, 1949), or Horn, H.J.
Biometrics 12:311, 1956.

Principles of method if other than guideline:

Study conducted before OECD 402 was in existence.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

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

Details on test material:

Name: AD 1
Chemical Name: N, N-Dimethyloctylamine
CAS No.: 7378-99-6
Batch No.: 13602808
Expiry Date: not applicable
Physical State at Room Temperature: liquid
Colour: clear
Volatility: volatile
Density: 0.765
Molecular Weight: 157.3
Active Components: > 95%
Structure Formula of
Active Component: C8H17-N-(CH3)2
Storage Conditions: at room temperature

Specific details on test material used for the study:

ADMA C8
Clear liquid, specific gravity 0.76 g/L

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

New Zealand White rabbits, approximately 8 weeks old when received, were equilibrated for at least one week in this laboratory. Apparently healthy rabbits were selected for the test. The animals were identified by cage tags noting the test material, starting date, animal number and sex. In addition, odd numbered animals in each cage were identified with an indelible ear mark. The animals were housed 2/cage in suspended wire mesh cages (30 11 x 18" x 1811). Fresh Purina rabbit chow and water were freely available. The animal room reserved exclusively for rabbits on acute tests, was maintained at 20 - 21 0 C and was kept clean in accordance with the standards of AAALAC of which this laboratory is an approved member.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The test material was applied once dermally to the prepared site under gauze patches. The patches were secured with adhesive tape and the trunks were wrapped with impervious material.

Duration of exposure:

The test material was kept in contact with the skin for 24 hours, at which time the wrappings were removed. An estimate of the amount of material remaining was recorded.

Doses:

20,000 mg/kg - group 1
16,000 mg/kg - group 2
4,000 mg/kg - group 3
1,000 mg/kg - group 4

No. of animals per sex per dose:

2 male/ 2 female - group 1
4 female - group 2
4 male - group 3
4 male - group 4

Control animals:

no

Details on study design:

A limit test was performed in which group one of two male and two female rabbits received a single dermal administration of the test article at a dose of 20,000 mg/kg body weight. Following dosing, all 4 rats died within 90 minutes therefore 3 additional groups of four rabbits were dosed at log intervals in an attempt to determine the LD 50. Doses were selected in an attempt to achieve at least two "partial kills"and if possible a "zero kill" and/or a "100% kill".
Dermal reactions were scored at 24 hours by the Draize scoring system. The rabbits were observed daily for14 days for signs of toxicity, pharmacological effects and mortality. Body weights were recorded
pretest and in the survivors at 14 days. If there were deaths duri ng the study, all animals in the high dose group were examined for gross pathol ogy. In the lower dose levels, only animals which died during the study were examined for gross pathology.

Statistics:

The LD 50, if possible, was calculated according to the method of Litchfield J.T. Jr. & F. Wilcoxon (J. Pharm. & Exp. Therap. 96:99, 1949), or Horn, H.J. Biometrics 12:311, 1956.

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

approximate LD50

Effect level:

4 000 mg/kg bw

Based on:

test mat.

Mortality:

0/4, 2/4, 4/4 and 4/4 animals died using this test substance at dose levels of 1,000, 4,000, 16,000 and 20,000 mg/kg of body weight respectively.

Clinical signs:

other: Skin reactions were pronounced; erythema was generally severe while edema was mostly moderate. The most common toxic sign was lethargy.

Gross pathology:

Animals dying before Day 14 had respiratory, cardiac and skin abnormalities.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The test article, when administered by dermal to male New Zealand White rabbits, has an estimated acute dermal LD50 of 4,000 mg/kg bw

Executive summary:

The test article, N,N-dimethyloctan-1-amine, was administered once dermally to the prepared site under gauze patches of male/female New Zealand White rabbits at varying test item concentrations. has an estimated acute dermal LD50 of 4,000 mg/kg bw.

0/4, 2/4, 4/4 and 4/4 animals died using this test substance at dose levels of 1,000, 4,000, 16,000 and 20,000 mg/kg of body weight respectively.

Skin reactions were pronounced; erythema was generally severe while edema was mostly moderate. The most common toxic sign was lethargy. Several surviving animals lost considerable amounts of weight.

Animals dying before Day 14 had respiratory, cardiac and skin abnormalities. The estimated acute dermal LD50 was determined to be 4,000 mg/kg bw.