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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
February 16, 1988 to March 02, 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
no GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
CAS 68140-00-1
Lot/batch No.:3
pH ca. 9 (at 20g/L]
amine-like odour
melting point ca. 69-73°C

Test animals

Species:
rabbit
Strain:
other: Small White Russian
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2.2 - 2.7 kg
- Housing: steel cages
- Diet (e.g. ad libitum): K4 diet for rabbit, Ssniff Special Diets, Soet, Germany
- Water (e.g. ad libitum): tap water

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

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of product with 0.5 cm3 water
Duration of treatment / exposure:
4 h
Observation period:
14 days (1, 24, 48, 72 hours, 6, 8, 10, 14 days after removal of wrapping)
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: exposure site covered with 2.5 x 2.5 cm patch. 6 x 6 cm Polyethylene wrapping placed on top and fixed with an elastic band.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing with warm water directly after patch removal.
- Time after start of exposure: 4 h


SCORING SYSTEM: OECD 404 method

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
3.67
Max. score:
8
Reversibility:
fully reversible within: 14 days

Any other information on results incl. tables

Table 1: Skin irritation responses in rabbit exposed to test substance

 Animal N°  1 h        24 h    48 h    72 h      6 d 8 d     10 d    

  14 d

 S  R
 2  1  2  1  2  1  x2  1  Sc SciA 0 0 0  0
2  2  2  3  1  2  1  x2  1  Sc  SciA  SciA 0  0
3  2  3  3  2  3  1  x3  1 Sc SciA  SciA 0  0

R: redness (erythema); S: swelling (oedema); x: spotty skin reaction; Sc: eschar; iA: detaching

Absolute average

4,00 4,00 3,33 3,33 => 14.66/4 =3.67

Assessment according to Appendix VI of Directive 79/831/EC:

Redness (erythema): average = 2.44

Swelling (oedema): average = 1.11

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Under the test conditions, the test substance was moderately irritating to rabbit skin.
Executive summary:

An OECD guideline 404 study was performed to assess the skin irritation potential of Cocamide MEA (CAS 68140 -00 -1) in rabbits. The test substance was applied in water to the shaved skin of three rabbits using an occlusive bandage. After 4 hours, the exposed skin was rinsed and then observed for 14 days. Redness (erythema), swelling (oedema) and eschar formation was apparent in all animals. The effects were reversible within 14 days. The overall irritation index was 3.67 (on a total possible of 8).

The test substance was therefore considered to be moderately irritating to rabbit skin under the conditions of the study.


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