N-(3-aminopropyl)iminodiethanol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study performed according to the OECD guideline 402 and GLP compliant

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-(3-Aminopropyl)diethanolamine

IUPAC Name:

N-(3-Aminopropyl)diethanolamine

Constituent 2

Reference substance name:

N-(3-aminopropyl)iminodiethanol

EC Number:

225-642-0

EC Name:

N-(3-aminopropyl)iminodiethanol

Cas Number:

4985-85-7

Molecular formula:

C7H18N2O2

IUPAC Name:

2-[(3-aminopropyl)(2-hydroxyethyl)amino]ethan-1-ol

Constituent 3

Reference substance name:

APDEA

IUPAC Name:

APDEA

Test material form:

liquid: viscous

Details on test material:

- Name of test material (as cited in study report): APDEA-
- Physical state: Clear slightly yellow liquid
- Analytical purity: 90.7%
- Impurities (identity and concentrations): no data
- Purity test date: no data
- Lot/batch No.: TG70L02N
- Expiration date of the lot/batch: December 2, 20 Il
- Stability under test conditions: Test substance was expected ta be stable for the duration of testing.
- Storage condition of test material: no data

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories, Inc. on May 20, 2011.
- Age at study initiation: 9 weeks
- Weight at study initiation: 233-249 grams and females 172-184 grams
- Fasting period before study: no
- Housing: singly housed in suspended stainless steel caging with mesh floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23°C
- Humidity (%): 45-78% The humidity was above the targeted upper limit for four days during the study. A portable dehumidifier was used to lower the humidity levels during this time. This slightly increased humidity does not affect the integrity of this study.
- Air changes (per hr): 12 to 14
- 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: 2 inches x 3 inches
- % coverage: approximately 10% of the body surface
- Type of wrap if used: 3-inch Durapore tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gently cleaning of any residual test substance.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000mg/kg
- Constant volume or concentration used: yes

VEHICLE
none

Duration of exposure:

24h

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 males and 5 females

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: during the first severa! hours after application and at !east once daily thereafter for 14 days.
- Frequency of weighing: prior to test substance application (initial) and again on Days 7 and 14 (termination).
- Necropsy of survivors performed: yes
- Other examinations performed: gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavior pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea, and coma.
Gross necropsies were performed on all animals. Tissues and organs of the thoracic and abdominal cavities were examined.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality

Mortality:

All animals survived exposure to the test substance during the study.

Clinical signs:

other: Dermal irritation was noted at the dose site of all animals between Days 1 and 14.

Gross pathology:

No gross abnorrnalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.

Any other information on results incl. tables

 

INDIVIDUAL CAGE-SIDE OBSERVATIONS

Animal number	Findings	Day of occurence
Males
3201	Active and healthy	0(1-4.5 hrs), 8-14
	Erythema at dose site	1-4
	Desquamation at dose site	5-7
3202	Active and healthy	0(1-4.5 hrs), 4-14
	Erythema at dose site	1-3
3203	Active and healthy	0(1-4.5 hrs), 7-14
	Erythema at dose site	1-3
	Desquamation at dose site	3-5
	Small areas of eschar at dose site	5-6
3204	Active and healthy	0(1-4.5 hrs)
	Blanching	1-4
	Erythema at dose site	1-5
	Areas of dark discoloration at dose site	1-5
	Small areas of eschar at dose site	5-7
	Eschar at dose site	8-14
3205	Active and healthy	0(1-4.5 hrs), 14
	Blanching	1-4
	Erythema at dose site	1-5
	Areas of dark discoloration at dose site	1-5
	Small areas of eschar at dose site	5-13

 

Animal number	Findings	Day of occurence
3206	Active and healthy	0 (1-4.5 hrs), 14
Females
	Erythema at dose site	1-5
	Areas of dark discoloration at dose site	1-6
	Small areas of eschar at dose site	5-13
3207	Active and healthy	0(1-4.5 hrs)
	Erythema at dose site	1-3
	Desquamation at dose site	4-12
	Small areas of eschar at dose site	5-14
3208	Active and healthy	0(1-4.5 hrs), 12-14
	Erythema at dose site	1-4
	Areas of dark discoloration at dose site	1-6
	Desquamation at dose site	5
	Small areas of eschar at dose site	5-11
3209	Active and healthy	0(l-4.5hrs), 14
	Areas of dark disco1oration at dose site	1-4
	Erythema at dose site	1-1 1
	Desquamation at dose site	5-7
	Small areas of eschar at dose site	5-13
3210	Active and healthy	0(1-4.5 hrs)
	Erythema at dose site	1-4
	Blanching	1-4
	Areas of dark discoloration at dose site	1-6
	Small areas of eschar at dose site	5-6, 14
	Eschar at dose site	7-13

 

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study, the single dose acute dermal LD0 of N-(3-Aminopropyl)diethanolamine is greater than 2,000 mg/kg of body weight in male and female rats.

Executive summary:

An acute dermal toxicity test was conducted with rats to determine the potential for N-(3-Aminopropyl)diethanolamine

to produce toxicity from a single topical application.

Two thousand milligrams of the test substance per kilogram of body weight was applied to the skin of ten healthy rats for 24 hours. The animals were observed for mortality, signs of gross toxicity, and behavioral changes at least once daily lor 14 days. Body weights were recorded prior to application and again on Days 7 and 14 (termination). Necropsies were performed on all animals at terminal sacrifice. All animals survived exposure to the test substance during the study. Dermal irritation was noted at the dose site of all animals between Days 1 and 14. Although two females lost weight through Day 7, all animals gained body weight over the 14-day observation period. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.

Under the conditions of this study, the single dose acute dermal LD0 of N-(3-Aminopropyl)diethanolamine

is greater than 2,000 mg/kg of body weight in male and female rats.