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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:
2000-01-26 to 2000-02-02
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
July 1992
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
29 Decembre 1992
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Kißlegg, Germany
- Age at study initiation: about 16 weeks
- Weight at study initiation: 3.27 kg (range from 3.20 to 3.36)
- Housing: separately in special rabbit cages (manufacturer: Becker; type K99/30 KU, floor area about 5400 cm², a shelter with an integrated sitting board of about 1820 cm²; overall height: 60 cm;)
- Diet: ad libitum, pellets (Altromin Standard Diet TPF(R) 2113)
- Water: ad libitum, tap water
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22
- Humidity (%): 37 - 64
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
8 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: left side of the animals backs (3 patches of about 6 cm²
- Type of wrap: self-adhesive fabric (Fixomull® stretch, Beiersdorf)

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

OBSERVATION TIME POINTS
1, 24, 48, 72 hours and then daily upt o study day 8

SCORING SYSTEM:
- Method of calculation: according to the DRAIZE-, OECD- and EEC recommendations

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No signs of irritation were observed in any of the 3 animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to the conducted study, the test substance is not regarded as irritant to the skin.
Executive summary:

The test on skin irritation was performed in accordance with OECD TG 404. The test substance (0.5 mL) was spread onto 6 cm² patches (3) and applied to the intact skin of 3 previously shaven New Zealand White rabbits (females) for a 4 hours period under semiocclusive conditions. The first examination of the treated skin sites followed 1 hour after removal of the patches. Thereafter, examinations were performed daily for further 8 days.

Under the conditions of the present study, no signs of toxicity were seen.

Evaluation of each animal:

 

Mean score (24h, 48h, 72h)

Maximum value (24h, 48h, or, 72h)

Animal No.

1

2

3

1

2

3

Erythema

0

0

0

0

0

0

Edema

0

0

0

0

0

0

No signs of irritation were observed in any of the 3 animals. Thus, the test material was not considered as a irritant to the skin.