Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test method according to OECD 404. GLP study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): OS 2200 (489-95A)
- Physical state: Clear to light yellow liquid.
- Analytical purity: >92%
- Lot/batch No.:38659-14
- Expiration date of the lot/batch: 1 January 1996
- Storage condition of test material: Room temperature in dark under nitrogen

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL.
Duration of treatment / exposure:
4 hours.
Observation period:
11 days because the reactions resolved in all animals within this period.
Number of animals:
3.
Details on study design:
SCORING SYSTEM: Local dermal irritation was assessed using the prescribed numerical 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 (beef redness) to slight eschar formation (injuries in depth) preventing grading of erythema: 4

Oedema formation
No oedema: 0
Very slight oedema (barely perceptible): 2
Moderate oedema (raised approximately 1 mm): 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure: 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: 24, 48 and 72 h.
Score:
2
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: 24, 48 and 72 h.
Score:
1.66
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: 24, 48 and 72 h.
Score:
0.33
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 h.
Score:
1.33
Max. score:
2
Reversibility:
fully reversible within: 11 days
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: 24, 48 and 72 h.
Score:
1.33
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: 24, 48 and 72 h.
Score:
0.66
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: 24, 48 and 72 h.
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 h.
Score:
0.663
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Very slight to well-defined redness with or without very slight to slight swelling was seen in all three animals. This was accompanied by dryness and sloughing of the skin.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance was determined to be not an irritant to the skin.
Executive summary:

A study was performed to assess the skin irritation potential of OS 2200 to the rabbit in accordance with OECD Guideline 404 (GLP study). Three rabbits received a single four hour, semi-occlusive, dermal administration of approximately 0.5 mL of the test substance as supplied and were observed for eleven days (fully reversible). Very slight to well-defined redness with or without very slight to slight swelling was seen in all three animals. This was accompanied by dryness and sloughing of the skin. These reactions resolved in all animals within 11 days of the exposure. The observed mean scores (24 -72h) for each animal were 2, 1.66 and 0.33 for erythema and 1.33, 0.66 and 0 for oedema. The test item was determined to be not irritating to the skin according to CLP Regulation.