3-{2-[2-(3-azaniumylpropoxy)ethoxy]ethoxy}propan-1-aminium di[(2Z)-3-carboxyprop-2-enoate]

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,3'-oxybis(ethyleneoxy)bis(propylamine)

EC Number:

224-207-2

EC Name:

3,3'-oxybis(ethyleneoxy)bis(propylamine)

Cas Number:

4246-51-9

Molecular formula:

C10H24N2O3

IUPAC Name:

3,3'-[oxybis(ethane-2,1-diyloxy)]dipropan-1-amine

Test material form:

liquid

Specific details on test material used for the study:

- Name of test material (as cited in study report): 4,7,10-Trioxatridecan-1,13-diamin
- Physical state/appearance: yellowish liquid
- Purity: min 95%
- Impurities: 4,7-Dioxanonan-9-ol-1-amin
- Expiration date of the lot/batch: July 1985

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, FRG
- Weight at study initiation: mean males: 259 g; mean females: 218 g
- Housing: single housing (type DK-III, Becker & Co., Castrop-Rauxel, FRG)
- Diet: Kliba-Labordiaet (Klingentalmuehle AG, Kaiseraugst, CH) ad libitum
- Water: tap water ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: ca. 50 cm² of shaved dorsal/dorsolateral skin
- Type of wrap if used: semiocclusive

REMOVAL OF TEST SUBSTANCE
- Washing: with warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: 2.15 mL/kg
- Concentration: undiluted

Duration of exposure:

24 hours

Doses:

2150 mg/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: check for mortality/moribund animals twice per day on working days and once per day on weekends/public holidays; clinical observation several times on the day application, afterwards at least once per day on working days; weighing on the day of application and on days 2, 6 and 13
- Necropsy of survivors performed: yes
- Other examinations performed: assessment of local effects (30 - 60 min after removal of semiocclusive coverage and afterwards at least once per week)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 150 mg/kg bw

Based on:

test mat.

Mortality:

One male animal died 2 days after application of the test substance.

Clinical signs:

other: Clinical signs included dyspnoea, apathy, aggressiveness, staggering, poor general state.

Gross pathology:

Animal that died: lungs: severe edema
Sacrificed animals: no abnormalities in organs observed

Other findings:

Local skin effects: 1 male animal moderate, 1 male animal superficial erosions with crust formation; other animals: profound necrosis.

Any other information on results incl. tables

Mortality:

Dose (mg/kg)		2150
Males
Dead animals/total animals after	1 h	0/5
	1 d	0/5
	2 d	1/5
	7 d	1/5
	14 d	1/5
Females
Dead animals/total animals after	1 h	0/5
	1 d	0/5
	2 d	0/5
	7 d	0/5
	14 d	0/5

 

Mean body weights (g):

	Dose (mg/kg)	Weight day
		0	2	6	13
Males	2150	259	241	263	292
Females	2150	218	241	211	231

 

Symptoms (cageside observations):

Dose (mg/kg)	2150
Males
Dyspnoea	2D-5D
Apathy	2D-5D
Agressiveness	8D-9D
Staggering	2D-5D
Poor general state	2D-5D
Females
Dyspnoea	2D-6D
Apathy	2D-5D
Agressiveness	6D-9D
Staggering	2D-6D
Poor general state	2D-6D

D: Day

 

Local effects

Dose (mg/kg)	2150
Males
Profound necrosis	1D-14D
Edema	1D-14D
Females
Profound necrosis	1D-14D
Edema	1D-14D

D: Day

Applicant's summary and conclusion

Interpretation of results:

other: slightly toxic

Remarks:

Migrated information

Conclusions:

Under the conditions of the study, the LD50 for acute dermal toxicity in the rat has been determined to be 2150 mg/kg/bw.

Executive summary:

Under the conditions of the study, the LD50 for acute dermal toxicity in the rat has been determined to be 2150 mg/kg/bw.