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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
See endpoint summary for justification of read-across.
Cross-reference
Reason / purpose:
read-across source
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
09 August 2011 to 14 August 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(2002)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Version / remarks:
(1998)
Deviations:
no
Qualifier:
according to
Guideline:
other: Commission Regulation (EC) No 440/2008, L 142, Annex Part B (2008)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Bayrisches Landesamt für Gesundheit ud Lebensmittelsicherheit, Munich, Germany
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: Crl: KBL (NZW)
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany (The animals were derived from a controlled full-barrier maintained breeding system (SPF). According to Art. 9.2, No. 7 of the German Act on Animal Welfare the animals were bred for experimental purposes.)
- Age at study initiation: approximately 15 – 16 weeks
- Weight at study initiation: > 2kg
- Housing: in ABS - plastic rabbit cages, floor 4200 cm² (Semi barrier in an air-conditioned room)
- Diet: autoclaved hay and to Altromin 2123 maintenance diet for rabbits (lot no. 1415), rich in crude fibre, ad libitum
- Water: tap water (drinking water, municipal residue control, microbiological controls at regular intervals), ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±3 (recommendations of TVT [10], GV-SOLAS [11])
- Humidity (%): 55±10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 ml
Duration of treatment / exposure:
4 h
Observation period:
The animals were examined for signs of erythema and oedema 1 hour after the patch removal. For the determination of classification-relevant values, the animals were examined for signs of erythema and oedema 24, 48 and 72 hours after the patch removal.
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: dorsal area of the trunk
- Type of wrap if used: semi-occlusive

REMOVAL OF TEST SUBSTANCE
- Washing: the residual test material was removed with tap water.
- Time after start of exposure: 4 h

SCORING SYSTEM: according to OECD
Irritation parameter:
erythema score
Basis:
mean
Remarks:
over all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
over all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
No irritant or corrosive effects were observed on the intact skin of the three female rabbits after a contact time of 4 hours.
Other effects:
Neither mortalities nor significant clinical signs of toxicity were observed. The body weight was not affected by the test item application.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item was tested for its skin irritating properties according to the OECD TG 404 and in compliance with GLP. No irritant effects were noted during the 72 h observation period following 4 h of exposure. No deaths occured, no signs of systemic toxicity were reported, and the body weight was not affected by the treatment. Hence, classificaion for skin irritation according to 67/584/EEC and EC/1272/2008 is not warranted.

Data source

Materials and methods

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Purity approx. 99% (GC)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
90% solution, intact skin; 50% solution, intact skin; 90% solution abraded skin; 50% solution abraded skin
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
90% solution, intact skin; 50% solution, intact skin; 90% solution abraded skin; 50% solution abraded skin
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
90% solution, intact skin; 50% solution, intact skin; 90% solution abraded skin; 50% solution abraded skin
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
90% solution, intact skin; 50% solution, intact skin; 90% solution abraded skin; 50% solution abraded skin
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
90% solution, intact skin; 50% solution, intact skin; 90% solution abraded skin; 50% solution abraded skin
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
90% solution, intact skin; 50% solution, intact skin; 90% solution abraded skin; 50% solution abraded skin
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation

Applicant's summary and conclusion