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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:
June 5, 1997 to July 3, 1997
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: Crl:KBL(NZW)BR
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, KiBlegg
- Age at study initiation: about 14 weeks
- Weight at study initiation: 2.80-2.94 kg
- Housing: The rabbits were kept in an air conditioned room with separate cages (Becker, type K99/30 KU) with plastic grids on mobile racks.
- Diet (e.g. ad libitum): Altromin Standard Diet TPF 2113, pellets ad libitum
- Water (e.g. ad libitum): fresh tap water at least 3 times per week
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 59-70%
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light

IN-LIFE DATES: From: To: June 5, 1997 to July 3, 1997

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 g of the test material was mixed with a few drops of Aqua pro injectione and spread into three patches. The patches were fastened to the left side of the animals backs and kept in place by a self-adhesive fabric.
Duration of treatment / exposure:
4 hours
Observation period:
The rabbits were examined after 1 hour, 24, 48, and 72 hours after the patches were removed, and then daily until day 8.
Number of animals:
3 female rabbits
Details on study design:
TEST SITE
- Area of exposure: dorsal
- Type of wrap if used: Fixomull stretch, Beiersdorf

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1, 24, 48, 72
Score:
0.833
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
0.165
Irritant / corrosive response data:
After an exposure period of four hours, erythema scores 1 and 2 were observed in two animals from day 1 through day 4. In one animal, edema score 1 was observed in the treated area during days 2 and three.

Any other information on results incl. tables

Animal

2

4

6

Erythema

 

 

 

1 hour

2

0

1

24 hours

2

0

1

48 hours

2

0

1

72 hours

1

0

0

Day 5

0

0

0

Day 6

0

0

0

Day 7

0

0

0

Day 8

0

0

0

Edema

 

 

 

1 hour

0

0

0

24 hours

1

0

0

48 hours

1

0

0

72 hours

0

0

0

Day 5

0

0

0

Day 6

0

0

0

Day 7

0

0

0

Day 8

0

0

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The mean etythema and edema scores were below 1 and therefore the substance is not classified as a skin irritant according to EU GHS guidelines.
Executive summary:

This study examined the potential of the test substance to cause irritation to skin. The test substance was placed on the skin of 3 female rabbits for 4 hrs, and covered with a semi-occlusive patch. After 4 hrs, the test substance was removed with warm water. The animals were scored for signs of edema and erythema according to the Draize scale at 1, 24, 48, and 72 hrs and carried out through day 8 to ensure reversibility. A very slight sign of erythema was seen at hour 1, while signs of edema were seen at the 2 hr observation. The primary irritation index was 1.5, based on the cumulative mean scores of edema and erythema and all symptoms were fully reversible. The test substance is therefore not classified as a skin irritant according to EU GHS guidelines.