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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:
2007-10-25 to 2007-11-09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: E010005910

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperauter in the dark

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Ground to a powder

FORM AS APPLIED IN THE TEST (if different from that of starting material)
Solid powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan UK Limited, Bicester, Oxon, UK
- Age at study initiation: twelve to twenty weeks
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: Suspended cages
- Diet (e.g. ad libitum): Certified rabbit diet ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: >5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 degrees C
- Humidity (%): 30 to 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
3 min, 1 hour, 4 hours
Observation period:
7 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: Surgical adhesive tape and an elasticated corset

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Cotton wool soaked in distilled water
- Time after start of exposure: 3 minutes, 1 hour and 4 hours for one rabbit, and 4 hours for the remaining two

OBSERVATION TIME POINTS
1, 24, 48, and 72 hours after the removal of the test substance

SCORING SYSTEM:
- Method of calculation:
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 eschar formation preventing grading of erythema 4

Oedema Formation
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) 4

Any other skin reactions, if present, were also recorded.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
After 3 min exposure
Time point:
other: 1 hr
Score:
ca. 0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
After 3 min exposure
Time point:
24/48/72 h
Score:
ca. 0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
After 3 min exposure
Time point:
other: 1 hr
Score:
ca. 0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
After 3 min exposure
Time point:
24/48/72 h
Score:
ca. 0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
After 1 hr exposure
Time point:
other: 1 hr
Score:
ca. 0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
After 1 hr exposure
Time point:
24/48/72 h
Score:
ca. 0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1 hr
Score:
ca. 0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
After 1 hr exposure
Time point:
24/48/72 h
Score:
ca. 0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
After 4 hr exposure
Time point:
other: 1 hr
Score:
ca. 2
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
After 4 hr exposure
Time point:
24 h
Score:
ca. 2
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
After 4 hr exposure
Time point:
48 h
Score:
ca. 1
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
After 4 hr exposure
Time point:
72 h
Score:
ca. 1
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
After 4 hr exposure
Time point:
7 d
Score:
ca. 0
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
After 4 hr exposure
Time point:
other: 1 hr
Score:
ca. 1
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
After 4 hr exposure
Time point:
24 h
Score:
ca. 1
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
After 4 hr exposure
Time point:
48 h
Score:
ca. 0
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
After 4 hr exposure
Time point:
72 h
Score:
ca. 0
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
After 4 hr exposure
Time point:
7 d
Score:
ca. 0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
After 4 hr exposure
Time point:
other: 1 hr
Score:
ca. 0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
After 4 hr exposure
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
After 4 hr exposure
Time point:
7 d
Score:
ca. 0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
After 4 hr exposure
Time point:
other: 1 hr
Score:
ca. 0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
After 4 hr exposure
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
After 4 hr exposure
Time point:
7 d
Score:
ca. 0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
After 4 hr exposure
Time point:
other: 1 hr
Score:
ca. 0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
After 4 hr exposure
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
After 4 hr exposure
Time point:
7 d
Score:
ca. 0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
After 4 hr exposure
Time point:
other: 1 hr
Score:
ca. 0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
After 4 hr exposure
Time point:
24/48/72 h
Score:
ca. 0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
After 4 hr exposure
Time point:
7 d
Score:
ca. 0
Irritant / corrosive response data:
No corrosive effects were noted.

Any other information on results incl. tables

Sum of 24 and 72 -hour Readings (S): 4

Primary irritation index (S/6): 4/6 = 0.7

Classification: MILD IRRITANT

Applicant's summary and conclusion

Interpretation of results:
Category 3 (mild irritant) based on GHS criteria
Conclusions:
The test material produced a primary irritation index of 0.7 and was classified as a MILD IRRITANT to rabbit skin according to the Draize classification scheme.