1,2-Propanediamine, N1-(2-aminoethyl)-3-(4-ethoxyphenyl)-, hydrochloride (1:2), (2S)-

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from January to February 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

24 February 1987

Deviations:

yes

Remarks:

- 3 instead of 5 animals/sex used

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(S)-1-(4-Ethoxybenzyl)-3-azapentane-1,5-diaminedihydrochloride

EC Number:

606-947-1

Cas Number:

221640-21-7

Molecular formula:

C13 H23 N3 O . 2 Cl H

IUPAC Name:

(S)-1-(4-Ethoxybenzyl)-3-azapentane-1,5-diaminedihydrochloride

Test material form:

solid

Test animals

Species:

rat

Strain:

other: HAN: WIST (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Schering AG, Germany
- Mean weight at study initiation: 104-106 g (males) or 98-105 g (females)
- Housing: 1 animal per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23
- rel. Humidity (%): 50 - 58
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: 900 mg NaCl ad 100 ml bidist. water

Details on dermal exposure:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): I - VI: 98 - 106 + 0.05 mL vehicle
- Constant volume or concentration used: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.05 mL 0.9% NaCl solution

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:´weighing: on day 1, 8, and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All treated animals survived

Clinical signs:

other: no clinical findings

Gross pathology:

Autopsy revealed no compound-related findings.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

A single dermal administration of the test substance to male and female rats at the limit-dose 2000 mg/kg was tolerated without mortalities, compound-related clinical findings, effects on body weight gain and gross pathological findings. According to OECD TG 402 the dermal LD50 of the test substance is therefore > 2000 mg/kg body weight.

Executive summary:

In an acute dermal toxicity study similar to OECD TG 402 (adopted 24 February 1987), groups of young adult Wistar rats (3/sex) were dermally exposed to Triamine Dihydrochloride in physiological saline for 24 hours at a dose 2000 mg/kg bw. Animals then were observed for 14 days.

Dermal LD50 Combined = > 2000 mg/kg bw

No mortality occurred during the limit test.

The test item is of low Toxicity based on the combined LD50 value of > 2000 mg/kg bw.

There were no treatment related clinical signs, necropsy findings or changes in body weight.