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
Study period:
1999/06/09-1999/06/12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
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 Nederland, The Netherlands

- Age at study initiation: at least 6 weeks

- Weight at study initiation: <3.5kg

- Housing: Individually housed in labelled cages with perforated floors.

- Diet: Standard laboraory rabbit diet, ca. 100g/day

- Water: tap water, ad libitum

- Acclimation period: min. 5 days


ENVIRONMENTAL CONDITIONS

- Temperature (°C):21

- Humidity (%): 50

- Air changes (per hr): ca.15

- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: Adjacent areas of skin of each animal served as controls.
Amount / concentration applied:
TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.5ml

- Concentration (if solution): undiluted


Duration of treatment / exposure:
4 hour(s)
Observation period:
Observations were made 1, 24, 48, and 72 hours after exposure.
Number of animals:
3
Details on study design:
TEST SITE

- Area of exposure: skin of flank

- Type of wrap if used: The test substance on the skin was covered with a Metalline patch of 2x3cm, mounted on with Micropore tape which was wrapped around the abdomen and secured with Coban elastic bandage.


REMOVAL OF TEST SUBSTANCE

- Washing (if done): Skin was cleaned of residual test substance using water.

- Time after start of exposure: 4 hours


SCORING SYSTEM: According to guideline

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24/48/72h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Remarks on result:
other: no information available
Irritation parameter:
edema score
Remarks on result:
other: no information available
Irritant / corrosive response data:
No skin irritation was observed by 4 hours exposure to the test substance.
Other effects:
There was no evidence of corrosive effect on the skin. No staining of the treated skin by the test material was observed. 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:
GHS criteria not met
Conclusions:
The test material was found not irritating as determined in a reliable study conducted according to an appropriate test protocol, and in compliance with GLP.