Amines, C20-22-alkyldimethyl

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

09/1989-01/1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: According to the OECD Guideline and it is GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Amines, coco alkyldimethyl

EC Number:

263-020-0

EC Name:

Amines, coco alkyldimethyl

Cas Number:

61788-93-0

IUPAC Name:

61788-93-0

Details on test material:

- Physical state: clear, straw-coloured liquid

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, U.K
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.00-3.00 kg
- Housing: individually housed in suspended metal cages
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): free access
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 13-21
- Humidity (%): 47-69
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light):12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

A volume of 0.5 ml of liquid

Duration of treatment / exposure:

four hours

Observation period:

Approximately one hour, 24, 48 and 72 hours later

Number of animals:

six rabbits

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm


REMOVAL OF TEST SUBSTANCE
- Washing (if done): removed by dislilled water


SCORING SYSTEM:

Erythema and eschar formation:
No erythema:0
Very slight erythema (barely perceptible):1
Well-defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4

Oedema formation:
No oedema: 0
Very slight oedema (barely perceptible):1
Slight oedema (edges of area well-defined by definite raising):2
Moderate oedema (raised approximately 1 millimetre ):3
Severe oedema (raised more than 1 millimetre extending beyong the area of exposure):4

Results and discussion

Any other information on results incl. tables

see executive summary

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material was classified as CORROSIVE to the skin after a four-hour exposure period. Symbol "C" and risk phrase R 34 "CAUSES BURNS".

Executive summary:

A study was performed to assess the irritancy/corrosivity potencial of seventeen test materials to the skin of the New Zealand white rabbit. The method used followed that described in the OECD 404.

The substance was classified as corrosive (R34).