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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:
From the 4th June 1991 to the 25th April 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The methodology used in this study was equivalent to the current guideline requirements at the time the study was conducted. Although there are some minor deficiencies in reporting compared to modern requirements, the study is considered suitable as a key study for skin irritation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not applicable
Qualifier:
equivalent or similar to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
not applicable
Principles of method if other than guideline:
The procedures used in this study were designed to meet the requirements of the test for skin irritation described within document L251, sn EEC Commission Directive of 25 April 1984.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Test Item Storage: +4 °C in the dark
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: 4 ºC / Dark
- Stability under test conditions: Assumed stable
- Solubility and stability of the test substance in the solvent/vehicle: N/A
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: N/A

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
-Source: Recognised supplier
-Housing: In grid bottomed metal cages
-Diet: SQC standard rabbit pellets
-Water: main drinking water via automated watering system
-Acclimation period: 5 days

ENVIRONMENTAL CONDITION
-Temperature: 17 -21°C
-Humidity: 46 - 65%
-Air changes (per hour): Air conditioned
Photoperiod (hrs dark/hrs light): 12 hrs dark/12 hrs light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
observation was made after one, 24, 48, and 72 hours and 7 then 14days.
Number of animals:
4
Details on study design:
The day befoe dose the animals were placed in a restraining stocks and the dorsal surface of the trunk was clipped free of fur using an Oster Model A2 clipper with Angra blade.
On the day of doseing the animals were placed in a restraining stocks. 0.5ml aliqout of the test item was placed evenly over a 2.5 cm square of surgical lint. the lint was placed over the dorsal skin of the animal, the test item was held in contact with the skin under a semi-occlusive patch for 4 hour period. After which the patches were removed and skin reaction assesd after 1, 24, 48, and 72 hours and 7 and 14 days.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1h
Score:
2
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
1
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
1
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
7 d
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
7 d
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
14 d
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
14 d
Score:
0
Max. score:
0
Irritant / corrosive response data:
Mild inflamation observed during 7 day period but all effected had dissipated by 14 days.

Any other information on results incl. tables

1 Hour Observation

 

 Rabbit Number

 Erythema

 Oedema

 Comments

 383

2

0

None 

 385

1

0

 None

 388

1

0

 None

 395

2

 None

 

24 Hour Observation

 Rabbit Number

 Erythema

 Oedema

 Comments

 383

0

0

None 

 385

1

0

 None

 388

1

0

 None

 395

2

 None

48 Hour Observation

 Rabbit Number

 Erythema

 Oedema

 Comments

 383

0

0

None 

 385

1

0

 None

 388

1

0

 None

 395

2

 None

72 Hour Observation

 Rabbit Number

 Erythema

 Oedema

 Comments

 383

1

0

None 

 385

3

2

 None

 388

2

1

 None

 395

2

1

 None

 

7 Day Observation

 Rabbit Number

 Erythema

 Oedema

 Comments

 383

0

0

Skin Thinkening

 385

1

0

 Skin Thickening

 388

1

0

 None

 395

0

 None

 

14 Day Observation

 Rabbit Number

 Erythema

 Oedema

 Comments

 383

0

0

None 

 385

0

0

 None

 388

0

0

 None

 395

0

 None

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item was concluded to be non irritant to the skin.
Executive summary:

The skin irritation potential of the test substance was evaluated using a method similar to OECD 404 and in accordance with GLP. In the test, 0.5 ml of the test item was applied to the clipped dorsal skin of 4 albino rabbits under semi-occlusion for a 4 hour period. Mild inflammation on day 7 was observed, which disappeared by day 14. From the result of the study, it was concluded that the test item would not require classification as a skin irritant.