O-ethylhydroxylamine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions (no data on substance purity)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

only 4 test animals used, occlusive dressing

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

O-ethylhydroxylamine

EC Number:

402-030-3

EC Name:

O-ethylhydroxylamine

Cas Number:

624-86-2

Molecular formula:

C2 H7 N O

IUPAC Name:

O-ethylhydroxylamine

Details on test material:

Name of test substance (as cited in report): ethoxyamine, 50% aqueous solution

Test animals

Species:

rat

Strain:

other: Alderly Park SPF albino rats

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: not specified
- Weight at study initiation: 299-344 g for males and 203-226 g for females
- Acclimation period: not specified


ENVIRONMENTAL CONDITIONS: no data

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE: Back
- Area of exposure: not specified
- % coverage: not specified
- Type of wrap if used: not specified


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


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): not specified
- Concentration (if solution): undiluted
- Constant volume or concentration used: differences in dose levels were achieved by altering the volume applied

Duration of exposure:

24 hours

Doses:

0.05; 0.4; 2 ml/kg bw (density 0.8827 g/ml) => 44.1; 353.1; 1765.4 mg/kg bw
- normalised to percentage (50%) of Substance H109360: 22.05, 176.6 and 882.7 mg/kg bw

No. of animals per sex per dose:

2

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations: The animals were examined for signs of systemic toxicity and skin irritation daily up to day 8 and on day 15
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathology

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 176.6 - < 882.7 mg/kg bw

Based on:

act. ingr.

Remarks on result:

other: No mortality at 22.05 and 176.6 mg/kg bw. All animals of the 882.7 mg/kg bw dose group died

Mortality:

At the dose levels of 22.05 and 176.6 mg/kg bw none of the animals died. All animals of the 882.6 mg/kg bw dose group died on day 1 of the study.

Clinical signs:

Clinical signs observed at the dose levels of 22.05 or 176.6 mg/kg bw included; tip-toe gait, stains around the nose, chromodacryorrhea, signs of urinary incontinence and upward curvature of the spine. These findings were discussed by the authors to be most probably due to the bandage as they were only seen on day 1 and/or day 2. The only sign of skin irritation observed was small scattered scabs.

Gross pathology:

No macroscopic findings were detected at necropsy

Applicant's summary and conclusion

Interpretation of results:

toxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study, the test substance H109360 (O-ethylhydroxylamine) is considered to be toxic after a single dermal application of > 176.6 mg/kg bw for 24 hours in both sexes.