Amines, N-(C16-18 and C18-unsatd. alkyl)trimethylenedi-, diacetates

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

significant methodological deficiencies

Remarks:

No substance identification; only "EC 63". No QA / GLP. Deviations from the current OECD402 guideline; 2 animals were used per sex per dose group in stead of 5. Half of the animals had abraded skin.

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)

Deviations:

yes

Remarks:

: Only 2 animals per sex per dose group were used, 4 animals in total, in stead of 5. Half of the animals had abraded skin.

Principles of method if other than guideline:

See deviations

GLP compliance:

no

Test type:

standard acute method

Test material

Test material information

1

Reference substance name:

N-C16-18-alkyl-(evennumbered) C18 unsaturated) propane-1,3-diamine

EC Number:

629-719-3

Cas Number:

1219010-04-4

Molecular formula:

CnH2n+1-NH-C3H6-NH2 and CnH2n-NH-C3H6-NH2

IUPAC Name:

N-C16-18-alkyl-(evennumbered) C18 unsaturated) propane-1,3-diamine

Details on test material:

Chemical registery number : 1219010-04-4
Chemical name : N-C16-18 (even numbered) and C18 (unsaturated) alkyl propane-1,3-diamine

Based on the qualitative and quantitative information on the composition, the sample used are representative of the boundary composition shared and agreed by each registrant.

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.13-3.00 Kg
- Fasting period before study: no data
- Housing: animals were caged individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 18
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: No data

Administration / exposure

Type of coverage:

occlusive

Vehicle:

propylene glycol

Details on dermal exposure:

TEST SITE
- Area of exposure: trunk of the animals
- % coverage: 10
- Type of wrap if used: The treated area was covered with a thin layer of cellulose sheet and wrapped in polyethylene foil .

REMOVAL OF TEST SUBSTANCE
- Washing (if done): test substance was removed from the skin with water and the animals were wiped dry with towels.
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.0 (control), 0.7, 1.4 and 2.0 g/kg body weight.
- Concentration (if solution): no data
- Constant volume or concentration used: yes; 9 ml/kg body

VEHICLE
- Amount(s) applied (volume or weight with unit): 9 ml/kg body
- Concentration (if solution): no data
- Lot/batch no. (if required): no data
- Purity: no data

Duration of exposure:

24h

Doses:

0.0 (control), 0.7, 1.4 and 2.0 g/kg body weight.

No. of animals per sex per dose:

2

Control animals:

yes, concurrent vehicle

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations and weighing at the start of the study and after week 1 and 2
- Necropsy of survivors performed: yes
- Other examinations performed: examinations were carried out for possible changes in blood composition and for macroscopic appear of severak organs, water and food consumption were measured.

Results and discussion

Effect levels

Key result

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality occured.

Clinical signs:

other: No clinical signs were observed.

Gross pathology:

Gross examination at autopsy did not reveal any treatment-related changes.

Other findings:

Haematological data were comparable for all groups.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

From the present results it is concluded that the product EC 63 is practically non-toxic in the case of one single dermal application. LD50 > 2000 mg/kg bw

Executive summary:

There is no substance identification; only "EC 63".

No QA / GLP.