Registration Dossier

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

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 (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: Crl:KBL(NZW)BR
- Sex: female
- Source: Charles River, Kißlegg, Germany
- Age at study initiation: adult
- Weight at study initiation: 2.1-2.9 kg
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 25
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: moistened with water
Controls:
other: contralateral untreated skin area of test animals served as control
Amount / concentration applied:
Amount: 0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, 72 hours after application
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: approx. 2.5 x 2.5 cm
- Type of wrap if used: gauze patch

REMOVAL OF TEST SUBSTANCE
- Washing: treated skin area carefully washed with water
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to Draize

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
Reversibility:
other: not applicable
Remarks on result:
other: mean score after 72 hours: 0.0
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: mean score after 72 hours: 0.0
Other effects:
No systemic intolerance reactions were observed.

Any other information on results incl. tables

Table 1. Summary of Irritant Effects (Score)

Animal

 

24 h

48 h

72 h

Mean Scores

Response

Reversible

(Days)

1

Erythema (Redness) and Eschar Formation

0

0

0

0.0

-

na

Oedema Formation

0

0

0

0.0

-

na

 

2

Erythema (Redness) and Eschar Formation

0

0

0

0.0

-

na

Oedema Formation

0

0

0

0.0

-

na

 

3

Erythema (Redness) and Eschar Formation

0

0

0

0.0

-

na

Oedema Formation

0

0

0

0.0

-

na

No positive response: Mean scores < 2 = -

Positive response:      Mean scores ≥ 2 = +

na: Not applicable

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Not irritating
Conclusions:
The test material was not irritating to the skin of rabbits according to OECD TG 404. No systemic intolerance reactions were observed.

Classification: not irritating
Executive summary:

In a dermal irritation/corrosion test test material meeting the form described in Section 4.5 of the IUCLID dossier was not irritating to the skin of rabbits according to OECD TG 404. No systemic intolerance reactions were observed.