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:
1992-MAR-24 through 1992-May-01
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
dilute test substance was also tested
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): HR 92/600 154
- Physical state: viscous liquid
- Analytical purity: 98.5%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae, Biberach, Germany
- Weight at study initiation: 2.0 to 2.5 kg
- Housing: singly
- Diet: feed pellets ad libitum
- Water: free access to drinking water, acidified with hydrochloric acid to pH 2.5
- Acclimation period: one week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3°C
- Humidity (%): 55 +/-15%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: ethanol (96%) and diethylphathalate; ratio 1:1 (w/w)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration: 1, 10, 25, 50, 100% (w/w)


VEHICLE
- Amount(s) applied (volume or weight with unit): 0 to 0.5 mL
- Concentration: 0 to 99%
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
4
Details on study design:
TEST SITE
- Area of exposure: 2.5x2.5 cm
- Type of wrap if used: gauze patches were secured with adhesive tape and loosely fixed with Scanpor tape


REMOVAL OF TEST SUBSTANCE
- Washing: with soap and lukewarm water at the end of the 4-hour exposure period
- Time after start of exposure: 4 hours


SCORING SYSTEM: according to the table contained in OECD TG 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: undiluted test substance
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: undiluted test substance
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: undiluted test substance
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: undiluted test substance
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: undiluted test substance
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: undiluted test substance
Irritant / corrosive response data:
No erythema or edema was noted during the study period in any animal with the unchanged or diluted test material.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU