2-octadecyl-1H-thioxantheno[2,1,9-def]isoquinoline-1,3(2H)-dione

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Data is from United States Environmental Protection Agency

Data source

Reference

Reference Type:

secondary source

Title:

Acute dermal toxicity study of 1-Hexadecanamine, N,N-dimethyl- in Rabbit

Author:

Calandra, J. C.

Year:

2016

Bibliographic source:

US EPA (United States Environmental Protection Agency), High Production Volume Information System (HPVIS), 2016.

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: as below

Principles of method if other than guideline:

Acute dermal toxicity study of 1-Hexadecanamine, N,N-dimethyl- in Rabbit

GLP compliance:

not specified

Test type:

other: No data

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Hexadecyldimethylamine

EC Number:

203-997-2

EC Name:

Hexadecyldimethylamine

Cas Number:

112-69-6

IUPAC Name:

N,N-dimethylhexadecan-1-amine

Constituent 2

Reference substance name:

1-Hexadecanamine, N,N-dimethyl-

IUPAC Name:

1-Hexadecanamine, N,N-dimethyl-

Details on test material:

- Name of test material (as cited in study report): 1-Hexadecanamine, N,N-dimethyl-
- Molecular formula (if other than submission substance): C18H39N
- Molecular weight (if other than submission substance): 269.513 g/mole
- Substance type: Organic

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

not specified

Details on test animals or test system and environmental conditions:

- Weight at study initiation: averaging 2.5 kg/bw

Administration / exposure

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

The test substance was administered undiluted. The hair on the backs of young, adult rabbits was clipped twenty-four hours prior to test substance administration. The test substance was applied to the back of each rabbit and gently, but thoroughly, rubbed into the exposure site and the site occluded with impervious plastic sheeting for 24 hours. Rabbits were observed for signs of toxicity for 14 days following removal of the plastic sheeting and excess test substance.

Duration of exposure:

once

Doses:

2200, 3300 and 4400 mg/kg bw

No. of animals per sex per dose:

Total: 12
2200 mg/kg bw: 4 rabbits
3300 mg/kg bw: 4 rabbits
4400 mg/kg bw: 4 rabbits

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data available
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: No data available

Statistics:

The method of Litchfield and Wilcoxon was used to determine the range-finding acute percutaneous mean lethal dose together with the LD0.01 and LD99.99

Results and discussion

Preliminary study:

No data available

Effect levels

Sex:

not specified

Dose descriptor:

LD50

Effect level:

2 359.5 mg/kg bw

Based on:

test mat.

95% CL:

1 705 - 3 355

Remarks on result:

other: No 50 % mortality observe d

Mortality:

When treated with 4400 mg/kg bw, Between 24 and 48 hours post dose, rabbit became extremely weak, lethargic and in a moribund state. These rabbits died within the next few hours.

When treated with 2200 and 3300 mg/kg bw, rabbits survived until study termination eventually showed signs of recovery.

Clinical signs:

other: No signs of toxicity were observed in the rabbits during the first six hours following test substance administration. Rabbits in all dose groups showed signs of generalized weakness and lassitude, and did not eat or drink 24 hours post dose. Signs of slig

Gross pathology:

No significant gross pathological changes were observed in treated rabbits.

Other findings:

No data available

Any other information on results incl. tables

Dose group	Number of deaths
2200 mg/kg bw	2/4
3300 mg/kg bw	3/4
4400 mg/kg bw	4/4

Applicant's summary and conclusion

Interpretation of results:

not classified

Conclusions:

LD50 was considered to be 2359.5 mg/kg bw (95% confidence limits = 1705 to 3355 mg/kg bw) when New Zealand White rabbits were treated with 1-Hexadecanamine, N, N-dimethyl- dermally.

Executive summary:

In a acute dermal toxicity study,New Zealand White rabbits were treated with 1-Hexadecanamine, N, N-dimethyl- dermally and observed for 14 days. At 4400 mg/kg bw., between 24 and 48 hours post dose, rabbit became extremely weak, lethargic and in a moribund state. These rabbits died within the next few hours. At 2200 and 3300 mg/kg bw, rabbits survived until study termination eventually showed signs of recovery. No signs of toxicity were observed in the rabbits during the first six hours following test substance administration. Rabbits in all dose groups showed signs of generalized weakness and lassitude, and did not eat or drink 24 hours post dose. Signs of slight transient erythema, and appeared dried, leathery and wrinkly were also observed in treated rabbits. At 2200 and 3300 mg/kg bw, hair loss and considerable decrease in body weight was observed in treated rabbits. No significant gross pathological changes were observed in treated rabbits. Therefore,LD50 was considered to be2359.5 mg/kg bw (95% confidence limits = 1705 to 3355 mg/kg bw) when New Zealand White rabbits were treated with 1-Hexadecanamine, N, N-dimethyl- dermally.