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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Also in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Genamin CC 100 D

Specific details on test material used for the study:
- Name of test material (as cited in study report): Genamin CC 100 D

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund, conventional breed
- Age at study initiation: about 3 -5 months
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: fully air-conditioned rooms, individual cages.
- Diet (e.g. ad libitum): ad libitum (Altromin 2123, Altromin GmbH (Lage/Lippe))
- Water (e.g. ad libitum): ad libitum (deionised, chlorinated water)
- Acclimation period:
- min. 7 days
- daily observation during acclimation period



ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +-3 °C
- Humidity (%): 50 +-20 %
- Photoperiod (hrs dark / hrs light): 12/12

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 mL

Duration of treatment / exposure:
3 min (3 animals)
1 h (3 animals)
Then test substance was removed cautiously from the skin with warm tap-water
Observation period:
30-60 min
24 / 48 / 72 hrs
7 / 14 / 21 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100 %
0.5mL of the test substance was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plater (specially produced by Beiersdorf AG, Hamburg. The plaster was fixed to the prepared skinarea (ca. 25 cm2) and then covered with a semi-occlusive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with warm tap water
- Time after start of exposure: 3 min (3 animals); 1h(3 animals)


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 (lesion in depth).........4

Oedema
No oedema...................................................................................................................................0
very slight oedema (barely perceptible)..................................................................................1
slight oedema (edges of area well defined by definite raising)............................................2
moderate oedema (raised approximately 1mm)....................................................................3
severe oedema (raised more than 1mm and extending beyond area of exposure.........4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
overall
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
1.9
Max. score:
3
Reversibility:
other: scare formation after 21 days
Remarks on result:
other: exposure 3 minutes
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.7
Max. score:
3
Reversibility:
other: scare formation after 21 days
Remarks on result:
other: exposure 3 minutes
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.7
Max. score:
2
Reversibility:
other: scare formation after 21 days
Remarks on result:
other: exposure 3 minutes
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
other: scare formation after 21 days
Remarks on result:
other: exposure 3 minutes
Irritation parameter:
edema score
Remarks:
overall
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
other: scare formation after 21 days
Remarks on result:
other: exposure 3 minutes
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
other: scare formation after 21 days
Remarks on result:
other: exposure 3 minutes
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
other: scare formation after 21 days
Remarks on result:
other: exposure 3 minutes
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
other: scare formation after 21 days
Remarks on result:
other: exposure 3 minutes
Irritation parameter:
erythema score
Remarks:
overall
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
1.77
Max. score:
3
Reversibility:
other: scare formation after 14 - 21 days
Remarks on result:
other: exposure 60 minutes
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.77
Max. score:
2
Reversibility:
other: scare formation after 21 days
Remarks on result:
other: exposure 60 minutes
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
other: scare formation after 21 days
Remarks on result:
other: exposure 60 minutes
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.67
Max. score:
3
Reversibility:
other: scare formation after 14 days
Remarks on result:
other: exposure 60 minutes
Irritation parameter:
edema score
Remarks:
overall
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
other: scare formation after 14 - 21 days
Remarks on result:
other: exposure 60 minutes
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
other: scare formation after 21 days
Remarks on result:
other: exposure 60 minutes
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.67
Max. score:
3
Reversibility:
other: scare formation after 21 days
Remarks on result:
other: exposure 60 minutes
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
other: scare formation after 14 days
Remarks on result:
other: exposure 60 minutes

Applicant's summary and conclusion

Interpretation of results:
Category 1A (corrosive) based on GHS criteria
Conclusions:
Based on the study report and the criteria laid down in the Directive 83/467/EEC or GHS system, the test substance has to be labelled as corrosive (C) with the designation R35 - causes severe burns, or Skin Corr. 1A, H314, respectively.
Executive summary:

In an OECD 404-compliant study, cocoalkylamines were applied on the skin of 6 rabbits. Severe erythema and moderate edema were observed for three minute exposure and one hour exposure time. After 24 hours following removal of the patches the skin was hardened, lumpy and discolored from light-brown to brown/black. The treated area was sharply confined to the untreated skin and in case of the animals with one hour exposure time circumvented with a white rim. From 7 days after removal of the patches, desquamation of coarse scales occurred and in some cases open wounds and 14 to 21 days after removal of the patches eschar formation was observed. The newly build skin was pergament-like, pink and scarred.

Based on the study report and the criteria laid down in the Directive 83/467/EEC or GHS system, the test substance has to be labelled as corrosive (C) with the designation R35 - causes severe burns, or Skin Corr. 1A, H314, respectively.

3 min-exposure:

Time after removal of the patch 30 - 60 min 24 h 48 h 72 h 7 d 14 d 21 d
Animal 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3
erythema and eschar formation 2 4 1 3 1 1 3 2 1 2 2 2 0 1 0 1 0 0 0 0 0
edema 1 1 1 3 2 3 2 1 2 1 1 1 0 0 0 0 0 0 0 0 0

1h-exposure:

Time after removal of the patch 30 - 60 min 24 h 48 h 72 h 7 d 14 d 21 d
Animal 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3 1 2 3
erythema and eschar formation 2 1 2 2 1 3 2 1 3 1 1 2 2 1 1 1 2 0 0 0 0
edema 1 1 1 2 3 2 1 1 1 0 1 1 0 0 0 0 1 0 0 0 0