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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992-01-30 to 1992-02-06
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction products of oleic acid, 2-(2-aminoethylamino)-ethanol, epichlorhydrin and bisulfit
Molecular formula:
not available for UVCB
IUPAC Name:
Reaction products of oleic acid, 2-(2-aminoethylamino)-ethanol, epichlorhydrin and bisulfit
Test material form:
solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.41 - 2.52 kg
- Housing: Housed in suspended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 18 - 22 °C
- Humidity: 46 - 56 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL of the undiluted test material
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours after removal of the patches
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- % coverage: 100
- Type of wrap if used: BLENDERM (surgical adhesive tape) + elastic corset (TUBIGRIP) around the trunk

REMOVAL OF TEST SUBSTANCE
- Washing: Test material was removed by gentle swabbing with cotton wool soaked in diethyl ether
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
One hour after washing, 24, 48 and 72 hours

SCORING SYSTEM:
- Method of calculation: The scoring followed the scale from Draize (1959)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
Very slight to well-defined erythema was noted at all treated skin sites one hour after patch removal and at the 24 and 48-hour observations. Very slight erythema was noted at two treated skin sites at the 72-hour observation.

Slight to moderate oedema was noted at all treated skin sites one hour after patch removal with very slight to moderate oedema at the 24-hour observation. Very slight or slight oedema was noted at two treated skin sites at the 48-hour. Very slight oedema was noted at one treated skin site at the 72-hour observation.

Desquamation was noted at all treated skin sites seven days after treatment.
Other effects:
Not observed

Any other information on results incl. tables

Table: Individual mean scores for dermal irritation

following 4 -hour exposure

Skin reaction Individual Scores - Rabbit Number and Sex (Bodyweight kg)
247 Male
(2.52)		 248 Male
(2.43)		 252 Female
(2.41)
Erythema Formation
Mean score		 1.7 1 0.7
Oedema Formation
Mean score		 2 0.7 0.3

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In a GLP-compliant Acute Dermal Irritation Test according to OECD Guideline 404, the test item was determined to be non-irritating to skin.
Executive summary:

The irritancy potential of the test item was assessed in a GLP-compliant Acute Dermal Irritation Test according to OECD Guideline 404. A quantity of 0.5 mL of the undiluted test material was introduced under a 2.5 cm x 2.5 cm gauze patch and placed in position on the shorn skin. The patch was secured in position with a strip of surgical adhesive tape (approximate size: 2.5 cm x 4.0 cm). To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP). Four hours after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in diethyl ether. Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the scale from Draize (1959). In result, very slight to well-defined erythema was noted at all treated skin sites one hour after patch removal and at the 24 and 48-hour observations. Very slight erythema was noted at two treated skin sites at the 72-hour observation. Slight to moderate oedema was noted at all treated skin sites one hour after patch removal with very slight to moderate oedema at the 24-hour observation. Very slight or slight oedema was noted at two treated skin sites at the 48-hour. Very slight oedema was noted at one treated skin site at the 72-hour observation. Desquamation was noted at all treated skin sites seven days after treatment. The test material produced a primary irritation index of 2.0. No corrosive effects were observed. As the mean score for erythema and oedema for each animal from gradings at 24, 48 and 72 hours after patch removal was below the value of 2.3 and effects were fully reversible within observation period, the test item is regarded to be not a skin irritant. The study is considered to be valid.