Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
from November 15 to 22, 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Source study has reliablity 1. Details on the read across are attached in section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK Ltd
- Weight at study initiation: 3.3, 2.7, 3.3 kg
- Housing: one rabbit per cage (Drahtkäfige Typ III - hoch)
- Pellet: Holzgranulat Typ S 8/15 (Firma Sniff, Soest)
- Diet: ca. 100 - 120 g per animal per day of Sniff K 4 (Sniff Spezialdiäten GmbH, Soest/Westfallen)
- Water: ad libitum
- Acclimation period: 1 day

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: ca. 50 %
- Air changes: ca. 10 times per hours
- Photoperiod (hrs dark / hrs light): 12 hours/12 hours (ca. 27 Watt/m2)

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 µl
- pH: 0.5
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: Application of the test item on Hansamed - Wundpflaster "Hypoallergen" Beisedorf n. 2342
- Coverage: Fixomull - Stretch klebevlies, Beisedorf n. 2039)

REMOVAL OF TEST SUBSTANCE
- Washing: yes, with water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize grade

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no skin reaction
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no skin reaction

Any other information on results incl. tables

animal n. weight sex 1hour 24 hours 48 hours 72 hours 7 days 14 days
E O E O E O E O E O E O
T54 3.3 kg female 0 0 0 0 0 0 0 0 0 0 0 0
T41 2.7 kg female 0 0 0 0 0 0 0 0 0 0 0 0
S13 3.3 kg female 0 0 0 0 0 0 0 0 0 0 0 0

 

E = erythema,  O = oedema

Applicant's summary and conclusion

Interpretation of results:
other: not irritant according to the CLP Regulation (EC 1272/2008)
Conclusions:
Not irritant.
Executive summary:

Method

The substance was tested according to OECD guideline 404, using 3 females of albino rabbit.

Results

No skin effects were noted during the 7 days of observation after application.