Ethanol, 2,2'-oxybis-, reaction products with ammonia, morpholine derivs. residues

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994-11-01 - 1994-11-04

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Ethanol, 2,2'-oxybis-, reaction products with ammonia, morpholine derivs. residues

EC Number:

272-712-1

EC Name:

Ethanol, 2,2'-oxybis-, reaction products with ammonia, morpholine derivs. residues

Cas Number:

68909-77-3

Molecular formula:

Not applicable (UVCB)

IUPAC Name:

2-(2-hydroxyethoxy)ethan-1-ol; 2-[1-(morpholin-4-yl)ethoxy]ethan-1-amine; 2-{2-[bis(2-hydroxyethyl)amino]ethoxy}ethan-1-ol; 4-{2-[2-(morpholin-4-yl)ethoxy]ethyl}morpholine; morpholin-3-one

Test material form:

liquid

Details on test material:

Name: Ethanol, 2,2'-oxybis-, reaction products with ammonia, morpholine derivs. residues
Physical state: liquid
Appearance: brown liquid

Specific details on test material used for the study:

- Name of test material (as cited in study report): AMINE C-8
- Substance type: dark brown slightly viscous liquid with crystalline sediment
- Physical state: liquid
- Analytical purity: no data
- Composition of test material, percentage of components: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: responsibility of the sponsor
- Storage condition of test material: at room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.23-2.29 kg
- Housing: individually in suspended metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-20 °C
- Humidity (%): 58-65%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1 November 1994 To: 4 November 1994

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): not applicable

Duration of treatment / exposure:

patches were removed after exposure periods of 3 min, 1 h and 4 h.

Observation period:

One hour after removal of the patches, and 24, 48 and 72 h.

Number of animals:

3 animals, with 3 test sites each

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: no data
- Type of wrap if used: gauze patches secured with strips of surgical adhesive tape and wrapped in an elasticated corset.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with cotton wool soaked in distilled water
- Time after start of exposure: 3 min, 1 hour and 4 hour

SCORING SYSTEM: Draize (1977) Primary Irritation Index.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0.2

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: Classification: mild irritant

Remarks:

4 hours exposure

Results 2

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: after 1 hour exposure

Results 3

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: after 3 minutes exposure

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Remarks on result:

other: after 3 minutes, 1 hour and 4 hours of exposure

Results 5

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0.3

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: after 4 hours of exposure

Irritant / corrosive response data:

After 3 min and 1 hour exposure: no erythema/eschar formation and no oedema formation.
After 4 hours exposure: very slight erythema in all three animals and very slight oedema in two animals, but fully reversible within 24-48 hours.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material does not need to be classified as a skin irritant according to the CLP Regulation.