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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
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
similar to OECD 404, non-GLP
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Lot/Batch No: 2619427

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Authorized distributor
- Housing: stainless individual cage
- Diet (e.g. ad libitum): 150g/day of special diet for experimental rabbits
- Water (e.g. ad libitum): automatic ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +- 2
- Humidity (%): 55 +- 25
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes
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
- Lot/batch no. (if required): 2619427
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: 6 square centimeter

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: 4 hours

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0

Any other information on results incl. tables

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 (injuries in depth) ............................ 4

Total possible erythema score 4

Edema formation

No edema .............................................................................................................................. 0

Very slight edema (barely perceptible) .....................................................................................1

Slight edema (edges of area well defined by definite raising) ..................................................... 2

Moderate edema (raised appoximately 1mm) .......................................................................... 3

Severe edema (raised more than 1mm and extending beyond area of exposure) ....................... 4

Total possible edema score 4

Weight table

 Rabbit  Weight (g)
 N° 1  2462
 N° 2  2492
 N° 3  2567

Mean valours of Erithemas and Edemas observed in rabbits after 1, 24, 48 and 72 h of application

   Mean score of Erithema  Mean score of Edema
 Rabbit N° 1  0.67  0.00
 Rabbit N° 2  0.67  0.00
 Rabbit N° 3  0.67  0.00
All   0.67  0.00

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Any of the rabbits treated with the substance has showed an erythema scored or edema score >=2. According to the test conditions the tested substance is not classified as skin irritant.
Executive summary:

3 New Zealand white rabbit were dosed with 0.5g or 0.5ml of solid samples or liquid samples respectively of substance. After 4 hours of exposure period the test material was removed with water or appropiate solvent and after 1, 24, 48 and 72 hours the animals were observed.

The sample is considered not irritating due to neither acute erithemas nor edemas are not seen in the animals after the substance is applied.