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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:
3 March 1999 - 20 May 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

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: Covance Research Products, Inc., Denver PA
- Age at study initiation: young adult
- Weight at study initiation: 3507 - 3642g
- Housing:Individual, suspended in wire mesh cages.
- Diet: PMI Nutrition International, Inc. Certified Lab Diet 5322, ca. 150g/day
- Water: reverse osmosis treated municipal water, ad libitum
- Acclimation period: minimum 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.5 - 19.4
- Humidity (%): 45.6-46.8%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL

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

- Concentration (if solution): undiluted


Duration of treatment / exposure:
4 hour(s)
Observation period:
72 hours
Number of animals:
1M, 2F
Details on study design:
TEST SITE

- Area of exposure: dorsal skin

- Type of wrap if used: Cotton gauze patches, secured with a gauze binder and surgical tape.


REMOVAL OF TEST SUBSTANCE

- Washing (if done): Excess test material was removed from treated skin areas following exposure.

- Time after start of exposure:4 hours


SCORING SYSTEM: Draize

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
0.2
Max. score:
1
Reversibility:
fully reversible
Irritant / corrosive response data:
See results section.
Other effects:
See results section.

Any other information on results incl. tables

No deaths or body weight changes were observed.  Very slight erythema was noted for one animal at the 48- and 72-hour
observations.   There was no edema or other dermal irritation noted.  A primary irritation index score of 0.2 was
calculated from the results, consistent with a slight skin irritation potential for A-172 in the rabbit.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material was found to be slightly irritating, as determined in a reliable study conducted according to to an appropriate test protocol. The observed effects do not meet the criteria for classification as a skin irritant in the EU.