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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 with acceptable restrictions

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:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Marlamid 1218 (CAS 68140-00-1)
- Physical state: solid
- Analytical purity: 100%
- Lot/batch No.: 3
- Other: pH ca. 9 (at 20 g/L), odour: amine-like, 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
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

Resultsopen allclose all
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
Irritation parameter:
erythema score
Basis:
animal: All
Time point:
24 h
Score:
>= 2 - <= 3
Max. score:
3
Reversibility:
fully reversible within: 14 d
Irritation parameter:
erythema score
Basis:
animal: All
Time point:
48 h
Score:
>= 2 - <= 3
Max. score:
3
Reversibility:
fully reversible within: 14 d
Irritation parameter:
erythema score
Basis:
animal: All
Time point:
72 h
Remarks on result:
other: Spotty skin reactions
Irritation parameter:
edema score
Basis:
animal: All
Time point:
24/48/72 h
Score:
>= 1 - <= 3
Max. score:
3
Reversibility:
fully reversible within: 14 d

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 study conditions, the test substance was therefore considered to be moderately irritating to rabbit skin.
Executive summary:

A study was conducted to assess the skin irritation potential of the test substance to rabbits according to OECD Guideline 404. The substance was applied in water to the shaved skin of three rabbits under an occlusive bandage. After 4 h, the exposed skin was rinsed then observed for 14 days. Redness (erythema), swelling (oedema) and eschar formation was apparent in all animals. The effects were reversible within 14 d. The overall irritation index was 3.67 (on a total possible of 8). Under the study conditions, the test substance was therefore considered to be moderately irritating to rabbit skin (Mürmann, 1988).