Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study according to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

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

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Weight at study initiation: approx. 2.8 kg
- Housing: polystyrene cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3 °C
- Humidity (%): 50 +/- 20
- Air changes (per hr): approx. 12
- Photoperiod (hrs dark / hrs light): 12 hours periodically

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin served as control
Amount / concentration applied:
0.5 mL/patch
Duration of treatment / exposure:
3 min (left flank)
4 h (right flank)
Observation period:
1, 24, and 48h after patch removal (when severe irritant effects were observed the test was immediately terminated and the animals were killed on
humane grounds).
Number of animals:
1
Details on study design:
TEST SITE
- Area of exposure: left and right flank
- % coverage: approx. 6cm²

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
3 min exposure
Time point:
other: 1h
Score:
2
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
3 min exposure
Time point:
other: 1h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
3 min exposure
Time point:
other: 24h
Score:
3
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
3 min exposure
Time point:
other: 24h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
4h exposure
Time point:
other: 1h
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
4h exposure
Time point:
other: 1h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
4h exposure
Time point:
other: 24h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: necrosis
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
4h exposure
Time point:
other: 24h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: necrosis
Irritant / corrosive response data:
The test item caused moderate to severe erythema and edema to the intact skin after a treatment period of 3 minutes and 4h. After 4h treatment the test material procuced epidermal necrosis indivative of corrosivity to the skin.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the study results the test material has to be considered as corrosive to skin.
Executive summary:

In an OECD TG 404 study, 0.5 ml the test material "Noram O" (oleylamine), a light brown, translucient and pasty liquid (purity 97.7%), was applied semi-occlusively for 3 minutes (left flank) and 4 hours (right flank) to the shaved skin of one New Zealand White Rabbit. The substance was applied as delivered by the sponsor onto a 6 cm2gauze pad, which was then applied to the right flank. The skin was examined 1 hour, 24, and 48 hours after removal of the dressing. Following the 3 minute exposure moderate to severe erythema and edema but no necrosis were observed. Following 4 hour exposure average Draize scores after 24 hours were 4.0 for erythema and 4.0 for oedema. At the same time necrosis was noted and the study was terminated for humane reasons.