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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 23rd December 1998 to 25th February 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: pale yellow liquid
- Storage condition of test material: The test substance was stored at room temperature in the dark.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: B & K Universal G.J., S.L.
- Age at study initiation: 10-12 weeks old
- Weight at study initiation: 2.5-2.7 kg
- Housing: The rabbits were housed individually in stainless steel cages (48 x 59 x 37 cm) with a grille floor, placed on racks.
- Diet (e.g. ad libitum): standard rabbit diet UAR 112, ad libitum.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-18 ºC
- Humidity (%): 55 ± 10%
- Photoperiod (hrs dark / hrs light): 12-hour light and 12-hour dark cycle per day.

IN-LIFE DATES: From: 21st December 1998 To: 15th January 1999

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
60 minutes, 24, 48 and 72 hours after the end of the exposure period
Number of animals:
Three
Details on study design:
TEST SITE
- Area of exposure: One square test zone, measuring approximately 6 cm2.
- Type of wrap if used: The substance was placed on 2.5 x 2.5 cm squares of surgical gauze and applied to the test area. The patches were held close to the body using strips of adhesive tape. A strip of gauze was wrapped around the trunk of the animal in order to hold the patches in place. The gauze was fixed to the body using additional adhesive tape.

SCORING 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 to slight eschar formation 4


Edema formation:
No edema 0
Very slight edema (barely perceptible) 1
Slight edema 2
Moderate edema 3
Severe edema 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24-72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24-72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24-72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24-72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24-72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24-72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Approximately 60 minutes after the patches were removed, well-defined erythema (grade 2) was observed in all animals. This lesion was accompanied by very slight edema (grade 1) in all of the animals.

After 24 hours, two of the animals presented very slight erythema (grade 1).

However, after 48 hours, only two animals continued to present very slight erythema (grade 1).

After 72 hours, no dermal lesions were observed in any animal.
Other effects:
The behaviour and physical condition of the rabbits were normal throughout the study.

Any other information on results incl. tables

 

Table 1: Primary skin irritation test

 

Animal

Reaction

60 min

24 h

48 h

72 h

1

Erythema

2

1

1

0

Edema

1

0

0

0

2

Erythema

2

1

1

0

Edema

1

0

0

0

3

Erythema

2

0

0

0

Edema

1

0

0

0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is considered to be non-irritant to the skin.
Executive summary:

The degree of skin initation caused by the test substance was detemined after it was applied to shaved rabbit skin, under a semi-occlusive patch, and left for 4 hours. The study was conducted according to EU method B.4 and OECD guideline 404.

Approximately 60 minutes after the patches were removed, well-defined erythema (grade 2) was observed in all of the animals. This lesion was accompanied by very slight edema (grade 1) in all of the animals.

After 24 hours, two of the animals presented very slight erythema (grade 1)

However, after 48 hours, very slight erythema (grade 1) was observed in only two animals.

After 72 hours, no dermal alterations were observed in any of the animals.

The mean etythema and edema scores for the substance, at 24, 48 and 72 hours after application, were 0.44 and 0.00 respectively.

The substance is considered to be non-irritant to the skin.