2-[(3-aminopropyl)methylamino]ethanol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2006-10-09 to 2007-01-17

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-[(3-aminopropyl)methylamino]ethanol

EC Number:

255-615-9

EC Name:

2-[(3-aminopropyl)methylamino]ethanol

Cas Number:

41999-70-6

Molecular formula:

C6H16N2O

IUPAC Name:

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

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: E-015/2005-1
- Expiration date of the lot/batch: no data
- Purity test date: 2005-10-24
- Purity: 99.01 wt% (GC)

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Solubility and stability of the test substance in the solvent/vehicle: no data

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan and Robinson Services
- Age at study initiation: 10-18 weeks at start of dosing
- Weight at study initiation: 1.9 to 3.5 kg (± 20% of the mean initial weight) at the outset (Day 1) of the study.
- Housing: Animals were group housed by sex upon receipt and individually housed upon assignment to study in compliance with USDA guidelines. Calvert is a USDA registered and fully AAALAC accredited facility. The room in which the animals were kept was documented in the study records. No other species were kept in the same room.
- Diet (e.g. ad libitum): All animals had access to PMI Certified Hi-Fiber Rabbit Diet #5325 as per Calvert SOP.
- Water (e.g. ad libitum): Tap water was available ad libitum, to each animal via an automatic watering device.
- Acclimation period: a minimum of 5 days prior to dosing.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 23°C
- Humidity (%): 23 to 94%
- Photoperiod (hrs dark / hrs light): 12 hours lighU12 hours dark

Administration / exposure

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal area of the trunk
- Type of wrap if used: The test article was applied on an intact skin site for each animal, covered with a gauze patch/dental dam, wrapped with an elastic bandage and secured with non-irritating tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After exposure the site was unwrapped and wiped with water or mineral oil and gauze to prevent ingestion.
- Time after start of exposure: twenty-four (±0.5) hours.

TEST MATERIAL
- Concentration (if solution): 2 ml/kg

Duration of exposure:

The test article was applied once and remains in contact with the skin site for twenty-four (±0.5) hours.

Doses:

400, 1000 and 2000 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:
Mortality/morbidity: once daily;
Clinical observations: Clinical observations were recorded daily through Day 15.
Body weight: Animals were weighed prior to dosing on Day 1 and on Days 8 and 15.
- Necropsy of survivors performed: yes,
All animals were euthanized by CO2 asphyxiation.
The necropsy included examination of the external body surface, all orifices, the cranial, thoracic and abdominal cavities and their contents

Statistics:

The design of this study is such that statistical analysis was not necessary.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 1 000 - < 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Mortality was not observed in any of the animals at 400 or 1000 mg/kg. One animal was found dead on Day 3 in the 2000 mg/kg group. Based on the clinical signs observed in the remaining animals at 2000 mg/kg they were euthanized on Day 3.

Clinical signs:

Clinical signs observed at 2000 mg/kg were of abnormal gait and stance, decreased activity, decreased body tone and red discolored fur. Clinical signs of abnormal gait and stance were observed during the study at the 400 and 1000 mg/kg dose levels with the addition of poor grooming at 400 mg/kg. No other clinical signs were observed throughout the study. Erythema, edema, necrosis, sloughing and flaking of the skin at the application site were observed during the study at all levels.

Body weight:

No biological effect on body weight was observed in surviving animals at 400 mg/kg. A reduced body weight gain was observed in animals at 1000 mg/kg between Days 1 and 15.

Gross pathology:

No visible lesions were observed in any of the animals dosed with the test article at 400 or 1000 mg/kg at terminal necropsy. Pale stomach, pale stomach lining, pale kidneys and red liquid in the bladders were observed at necropsy of the animals at 2000 mg/kg.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The dermal LD50 of the test substance was estimated to be greater than 1000 mg/kg but less than 2000 mg/kg (2 ml/kg). Based on the CLP criteria, the test substance is classified as acute dermal toxicant category 4.