Amines, N-C12-18-alkyltrimethylenedi-

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was performed pre-GLP and not according to standard protocol but comparable with OECD402. The animals were exposed to the test substance was under occlusion and the area of expsoure was 30%. Necropsy is only performed on the that died during the observation period. The substance is corrosive to skin and eyes but in this part of the study nothing is mentioned about skin damage.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Principles of method if other than guideline:

The test aniamls were exposed under occlusion and the test ietm covered 30% of the body surface.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Amines, N-C12-18-alkyltrimethylenedi-

EC Number:

268-957-9

EC Name:

Amines, N-C12-18-alkyltrimethylenedi-

Cas Number:

68155-37-3

Molecular formula:

R-NH-(CH2)3-NH2

IUPAC Name:

N-C12-18-alkyl-propane-1,3-diamine

Details on test material:

Duomeen C (N-coco-1 , 3 diaminopropane) no further data provided

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: H . A . R . E . - Rabbits for Research, Hewitt, N.J., US (H.A.R.E. - Rabbits i s a USDA approved supplier. )
- Age at study initiation: no data
- Weight at study initiation: no data
- Fasting period before study: not applicable
- Housing: individually in wire mesh bottom cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum if 5 days

ENVIRONMENTAL CONDITIONS
no data

IN-LIFE DATES:
no data

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: back and flanks
- % coverage: 30
- Type of wrap if used: The occlusive binder consisted of a layer of plastic wrap, a protective cloth and stockinette binder, all securely held in place with masking tape. The occlusive binder is applied to maintain contact and minimize evaporation of the applied test article .

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The exposure sites were then gently wiped with clean gauze to remove as much nonabsorbed test article as possible.
- Time after start of exposure: After an exposure period of 24 hours.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2g/kg
- Concentration (if solution): -
- Constant volume or concentration used: yes

Duration of exposure:

24h

Doses:

2g/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weights were recorded on the initial day of testing and at study termination or day of death.
- Necropsy of survivors performed: no

Statistics:

E . L . Crow, Biometrika, 43, 423-435 (1956)

Results and discussion

Preliminary study:

not peformed

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

One animal died during the 14 day observation period on day 13

Clinical signs:

other: not reported

Gross pathology:

not reported

Other findings:

not reported

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Remarks:

Migrated information

Conclusions:

One animal died on day 13. The LD50 for duomeen C is therefore > 2000 mg/kg bw

Executive summary:

The acute dermal toxicity Duomeen C was tested in New Zealand White Rabbits according to a study design similar to OECD 402. The back and flanks of 5 male and 5 female rabbits were clipped, constituting about 30% of the total body surface. Just prior of the application test substance, the skin surface was abraded in 3 of the males and 2 of the females. The animals received 2000 mg/kg undiluted test material, which was left under occlusion for 24 hours. After the 24 hours exposures, the sites were gently wiped with clean gauze to remove non-absorbed material. One animal died during the 15-day observation period on day 13. Consequently, LD50 was determined to be > 2000 mg/kg bw.