(2-hydroxyethyl)ammonium nitrate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable non-GLP study, comparable to guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

not applicable

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-hydroxyethylammonium chloride

EC Number:

217-900-6

EC Name:

2-hydroxyethylammonium chloride

Cas Number:

2002-24-6

IUPAC Name:

2-hydroxyethanaminium chloride

Details on test material:

- Name of test material: Härter 421 flüssig; Äthanolaminhydrochlorid 45 % (German)
- Physical state: liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: purchased from a breeder (Hagemann)
- Age at study initiation: young adult
- Weight at study initiation (group mean values): 208 g (males), 178 g (females)
- Diet: Herilan MRH-Haltung (H. Eggersmann KG, Germany)

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: back (21 cm²)
- Type of wrap if used: linen

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied: 1000, 4000 mg/kg bw
- Constant concentration used: yes, 100 % (volume was adjusted)

Duration of exposure:

24 hours

Doses:

1000, 4000 mg/kg bw

No. of animals per sex per dose:

3 rats

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs were recorded daily (with few exceptions), body weights were recorded after 1, 4, 6, 8, 11 and 13 day(s)
- Necropsy of survivors performed: yes

Statistics:

No statistical analysis was performed.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 4 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

other: There were no signs of systemic toxicity. Transient local signs of slight primary skin irritation were noted after 24 hours. No signs of skin irritation were seen from day 4 until the end of the observation period.

Gross pathology:

No macroscopic findings were noted at scheduled necropsy.