Amines, C16-18 and C18-unsatd. alkyl, ethoxylated

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

1990-02-20 - 1990-03-01

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Adequately performed and reported study following OECD 404 guidelines.

Justification for type of information:

Data has been generated in a category approach. A justification for cross-reading and explanation of the category approach is available in Chapter 13.

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-(octadec-9-enylimino)bisethanol

EC Number:

246-807-3

EC Name:

2,2'-(octadec-9-enylimino)bisethanol

Cas Number:

25307-17-9

Molecular formula:

C22H45NO2

IUPAC Name:

2,2'-[(9Z)-octadec-9-en-1-ylimino]diethanol

Details on test material:

purity: 100%
Appearance: yellow liquid
odour: amine like
Density: approx. 1 g/cm3
pH (at 20 ℃): approx. 11
melting point: approx. -14℃
Flash-point: approx. 218℃
Production data: 21.08.89
Batch: 2

Test animals

Species:

rabbit

Strain:

other: small white Russian, Chbb-SPF

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach
- number of animals: 3
- Marking: ear tattoo
- sex: male
- Age at study initiation: no data
- Weight at study initiation: 2,3-2,4 kg
- Housing: indiidual in steelcage
- Diet (e.g. ad libitum): ad libitum. K4 whole rabbit feed from Ssniff Spezialfutter GmbH, 4770 Soest.
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20℃ ± 1℃
- Humidity (%): 60% ± 5%
- Air changes (per hr): 15 /h
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 20.02.1990 To: 01.03.1990

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0,5 cm3
VEHICLE: no

Duration of treatment / exposure:

3 minutes, 1 hour and 4 hours

Observation period:

4 h exposure: 48 hour (and then terminated)
1 h exposure: 72 hour (and then terminated)
3 minutes exposure: up to 8 days.

Number of animals:

3 animals, one for each exposure period.

Details on study design:

TEST SITE
- Area of exposure: approx. 6 cm2
- Type of wrap if used: elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): careful rinsing with warm water.
- Time after start of exposure: 4 hr, 1 hr and 3 minutes respectively

SCORING SYSTEM:
As liste in OECD guideline

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

48 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

48 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Irritant / corrosive response data:

Exposure of 0,5 ml resulted to necrosis in following exposure duration of 4 hr, 1 hr and 3 minutes respectively

Any other information on results incl. tables

Results:

Animal

exposure

observation time

1 hour

24 hours

48 hours

72 hours

6 days

8 days

E

O

E

O

E

O

E

O

E

O

E

O

1

4 hr

x4

4

*N4

4

*N4

4

2

1 hr

2

2

*N4

4

*N4

4

*N4

4

3

3 min

2

2

*N4

4

*N4

4

*N4

4

*N4 Scp

4

*N4 Scpribl

4

E= erythema; O = Oedema

x = red/brown colouring of the application surface

* = red/brown colouring of the application surface, elevated crust, anemic (white) soft edge around crust.

N = Necrose

Scp = Crust

ri = fissures

bl = bloody

Applicant's summary and conclusion

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Remarks:

Migrated information

Conclusions:

Corrosive following 3 minute application to the skin after 24 hours but not at 1 hour.

Executive summary:

Exposure of the rabbit skin to 0,5 ml of undiluted test substance in acordance to OECD 0404 method, resulted to strong erythem and oedema and after 24 hours necrosis and development of crusts. There was no evidence of corrosion at the 1 hour observation time.