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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:
1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to OECD Guideline 404 and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

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 18R 100 D

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Madörin AG, Füllingsdorf, Schweiz
- Age at study initiation: about 3 -5 months
- Weight at study initiation: 2.5 - 3.0 kg
- Housing: in fully air-conditioned rooms, separate cages (arranged in a battery)
- Diet (e.g. ad libitum): Altromin 2123 maintenance diet - rabbits (Altromin GmbH, Lage/Lippe), ad libitum and hay (approx. 15 g daily)
- Water (e.g. ad libitum): deionised, dechlorinated water from automatic water dispenser, ad libitum

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:
other: PEG 400 (Riedel de Haen AG; Ch-B 2322)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg (moistened)

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.4 mL polyethylenegylcol 400 (Riedel de Haen AG; Ch-B 2322)
Duration of treatment / exposure:
4 hrs
Then test substance was removed from the skin with warm tap water
Observation period:
30 - 60 min. after removal of the patches
24, 48 and 72 hrs after removal of the patches
7 days after removal of the patches
Number of animals:
3
Details on study design:
TEST SITE
- 24 hrs prior to application an area of ca. 25 cm2 from the dorsal area of the corpus was removed with an electrical trimmer
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100 %
The moistened substance was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster. 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: 4 hrs


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:
other: 24 / 48h / 72h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 14 - 28 days
Remarks on result:
other: exposure 4 hours
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24h / 48h / 72h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 28 days
Remarks on result:
other: exposure 4 hours
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24h / 48h / 72h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: exposure 4 hours
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24h / 48h / 72h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: exposure 4 hours
Irritation parameter:
edema score
Remarks:
overall
Basis:
mean
Remarks:
all animals
Time point:
other: 24h / 48h / 72h
Score:
1.8
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: exposure 4 hours
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24h / 48h / 72h
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: exposure 4 hours
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean
Time point:
other: 24h / 48h 7 72h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: exposure 4 hours
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean
Time point:
other: 24h / 48h / 72h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: exposure 4 hours
Irritant / corrosive response data:
The irritation reactions exhibited clear tendency for recovery and were fully reversible. No irreversible skin damage was observed at the end of the
observation period.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Testing of Octadecylamine for primary dermal irritation in the rabbit showed that, based on the criteria laid down in the Directive 83/467/EEC, the
substance has to be labelled as irritant (Xi) with the designation R38 - irritates the skin.
Executive summary:

In a GLP compliant OECD TG 404 study, 0.5 g the test material Genamin 18 R 100 D (octadecylamine), a whitish waxy solid (purity approximately 100%), was applied semi-occlusively for 4 hours to the shaved skin of three New Zealand White Rabbits. The substance was moistened with 0.4 ml polyethylene 400. Examination of the treated skin was started approx. 30 minutes after patch removal and continued on days 2, 3 and 4. Additional observations were performed on days 7, 14, 21 and 28. 30-60 minutes up to 7 days after patch-removal, treated skin areas showed pronounced erythema and slight-moderate oedema. Average scores for erythema were 3.0 (24 hours), 3.0 (48 hours) and 3.0 (72 hours). Scores for oedema were 2.7, 1.3 and 1.3 for the same time points. Over time, skin was frequently dried and brittle, crusty and cracked. Additionally, enduration and desquamation was observed. Effects were reversible after 14 days in one rabbit and 21 respectively 28 days in the two other rabbits. Based on the study results, the test material Genamin 18 R 100 D has to be considered as irritating to skin.