O-ethylhydroxylamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline with acceptable restritions (Due marked systemic toxicity leading to death, a full assessment of irritation potential was not possible); no data on analytical purity, occlusive treatment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

(occlusive treatment, no data on analytical purity)

GLP compliance:

yes

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:

- CTL reference number: Y05460/002/001
- Name of test substance as cited in document: Substance H109360
- Identification of test sample as stated in report: 50% (w/v) aqueous solution (approx. 46.4% ethoxyamine and approx. 5% ethanol)
- Appearance: clear aqueous solution
- Lot #: EFI-100
- Analytical purity: not specified

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Mellor Rabbits, Chadderton Heights, Chadderton, Nr Oldham, Greater Manchester, UK .
- Age at study initiation: no data
- Weight at study initiation: 2669-3245g
- Housing: singly in satinised aluminium sheet cages
- Diet: Labsure CRB Rabbit Diet provided ad libitum
- Water: via an automatic system provided ad libitum
- Acclimation period: 6 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16
- Humidity (%): 40-60
- Air changes (per hr): 20-30
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated sites of the same animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 ml

Duration of treatment / exposure:

4 hours

Observation period:

30 minutes, 1, 2, and 3 days after removal of the dressings. Day 4 (only one animal)

Number of animals:

6 females (The skin of only two animals was scored fore changes at the scheduled time points)

Details on study design:

TEST SITE
- Body part: flank
- Area of shaved test site: 70 mm x 130 mm
- Area of exposure: 25 mm x 25 mm
- % coverage: approximate size 350 mm x 135 mm
- Type of wrap if used: impermeable polyethylene tape


REMOVAL OF TEST SUBSTANCE
- Washing: yes; using clean swabs of absorbent cotton wool soaked in clean warm water and was then dried gently with clean tissue paper
- Time after start of exposure: 4 hours after removal dressing


SCORING SYSTEM: The Draize scale (Draize 1959)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 2 animals

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: no effect

Remarks on result:

other: none

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 2 animals

Time point:

other: 24, 48 and 72 hours

Score:

0.2

Max. score:

4

Reversibility:

fully reversible within: 24 h

Remarks on result:

other: Marked systemic toxicity prevented a full assessment of irritation potential. One animal was found dead and three animals were killed in extremis one day after removal of the dressing.

Other effects:

All six animals were cyanotic at removal of the dressing and at the approximate 30 minute observation. One animal was found dead and three animals were killed in extremis one day after removal of the dressing. The signs of toxicity observed were cyanosis, decreased breathing rate and decreased activity. Marked systemic toxicity prevented a full assessment of irritation potential. However, signs of no more than slight irritation were observed following a single four-hour application of the test sample of Substance H109360 to rabbit skin.

Any other information on results incl. tables

Only two animals survived the treatment with the test substance right up till day 3 post removal of the test substance.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information