N,N'-bis(1,3-dimethylbutylidene)-2,2'-iminobis(ethylamine)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

Not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted in accordance with generally accepted scientific principles, with incomplete reporting or methodological deficiencies. This reference does not provide a full report with regard to the methods used in this study. Most basic key information is reported.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Modified I.R.L.G. Guidelines Method

Deviations:

not specified

Principles of method if other than guideline:

A single limit dose was applied to the abraded skin of male and female rabbits under a semi-occlusive dressing for 24 hours. The animals were observed for 14 days.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N,N'-bis(1,3-dimethylbutylidene)-2,2'-iminobis(ethylamine)

EC Number:

234-205-3

EC Name:

N,N'-bis(1,3-dimethylbutylidene)-2,2'-iminobis(ethylamine)

Cas Number:

10595-60-5

Molecular formula:

C16H33N3

IUPAC Name:

N-(1,3-dimethylbutylidene)-N'-{2-[(1,3-dimethylbutylidene)amino]ethyl}ethane-1,2-diamine

Test material form:

other: watery liquid

Details on test material:

- Physical details: light amber, watery liquid with a highly noticeable odour.
- Storage conditions: ambient room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Diet (e.g. ad libitum): ad libitum Wayne diet
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 240 cm² dorsal area, abraded
- Type of wrap if used: porous gauze dressing covered by a semi-occlusive wrapping of polyethylene sheeting.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): excess fluid is removed to prevent ingestion.
- Time after start of exposure: following removal of the semi-occlusive dressing after 24 hours.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.0 mL/kg

RESTRAINTS
Rabbits were restrained in a hood for the 24 hour contact period due to a danger of inhaling vapours from the test material.

Duration of exposure:

24 hours

Doses:

2.0 mL/kg

No. of animals per sex per dose:

2 animals per sex per dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and bodyweight

Statistics:

LD50 is calculated by probit transformation based on 14 days’ observation.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 mL/kg bw

Based on:

test mat.

Mortality:

There was no mortality seen.

Clinical signs:

other: The dosed animals had severe erythema within 1 hour and severe eschar and necrosis as a result of the 24 hour application. Scabbing and ulceration of the skin was seen by day 7. Hyperactivity was seen in the animals immediately after dosing. At 24 hours,

Gross pathology:

Kidney and lung pathology was evident at necropsy.
-One male animal had rounded, swollen and yellow kidneys; one female exhibited flattened, swollen and tan kidneys. One male and one female had kidneys with pitted surfaces.
-One male had a dark red upper right lobe of the lung; the other male had dark red lower lobes. One female showed brownish red lower lobes of the lungs.

Applicant's summary and conclusion

Conclusions:

Under the conditions of this study the LD50 was determined to be >2.0 mL/kg, dosed undiluted.

Executive summary:

The acute dermal toxicity of the test material was investigated in accordance with a modified I.R.L.G. Guidelines method.

A single limit dose of 2.0 mL/kg was applied to the abraded skin of 2 male and 2 female albino rabbits under a semi-occlusive dressing for 24 hours. The animals were observed for 14 days.

No mortality was seen though severe skin reactions were seen in all dosed animals. Kidney and lung pathology was evident at necropsy.

Under the conditions of this study the LD50 was determined to be >2.0 mL/kg, dosed undiluted.