Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19 October 2006 - 13 December 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: JMAFF Guidelines (2000)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan, Horst, The Netherlands
- Age at study initiation: at least 6 weeks
- Weight at study initiation: at least 1.0 kg
- Housing: animals were housed individually in labelled cages with perforated floors
- Diet: ca. 100 g per day of pelleted diet for rabbits (K-H from SNIFF® Spezialdiäten GmbH, Soets, Germany). Hay was provided at least three times a week.
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.4 - 23.2 °C
- Humidity (%): 42 - 69 %
- Air changes (per hr): ca. 15 air changes per day
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

Test system

Type of coverage:
semiocclusive
Vehicle:
other: The powdery test substance was moistened with 0.5 mL water (Milli-U)
Controls:
no
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Observation period:
72 hours
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: ca. 24 hours before treatment, the dorsal fur was clipped, exposing an area of ca 150 cm². To facilitate scoring, treated skin areas were re-clipped at least 3 hours before the observations.
- Coverage: each animals was treated by dermal application of 0.5 g of test material that had been moistened with 0.5 mL of water and applied to the skin of one flank.
- Type of wrap if used: the test material was covered with a metalline patch of 2 x 3 cm. The patch was mounted on Micropore tape which was wrapped around the abdomen and secured with Coban elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): four hours after application, the dressing was removed and the skin cleaned of residual test material with tap water.

SCORING SYSTEM: skin reaction were scored using the Draize scoring system.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Max. score:
1
Remarks on result:
other: Max. duration: 24 d; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Max. score:
0
Remarks on result:
other: Max. duration: d; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
IRRITATION
Four hours exposure to 0.5 g of test material resulted in very slight erythema in the treated skin-area of one rabbit. The skin irritation had resolved within 24 hours after exposure. No skin irritation was caused by the test material in the other two animals.

CORROSION
There was no evidence of a corrosive effect on the skin.

Other effects:
COLOURATION/ REMNANTS
No staining of the treated skin by the test material was observed and no test material remnants were seen.

TOXICITY/ MORTALITY
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study the test material was found not to be a skin irritant.
Executive summary:

The potential of the test material to cause skin irritation was investigated in a study which was conducted under GLP conditions and in accordance with the standardised guidelines OECD 404, EU Method B.4, EPA OPPTS 870.2500 and JMAFF Guidelines.

During the study three male rabbits were exposed to 0.5 g test material, moistened with water by application onto clipped skin for 4 hours using a semi-occulsive dressing. Skin reactions were assessed 1, 24, 48 amd 72 hours after exposure.

Exposure to the test material resulted in very slight erythema in the treated skin area of one rabbit, which resolved within 24 hours after exposure. No skin irritation effects were seen in the other two animals.

Based on these results, the test material was concluded not to be a skin irritant.