Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24.08 - 20.09.2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to guideline under GLP
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
not relevant
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: liquid
- Stability under test conditions: stable
- Storage condition of test material: at room temperature (range 20°C +- 5°C), light protected, under nitrogen

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Age at study initiation: 12 - 13 weeks (male), 9 - I I weeks (females)
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10-1 5
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped with electric clipper
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL of Dihydro-C14-Aldehyde was placed on a surgical gauze patch (ca. 2.5 cm x 2.5 cm
- Concentration (if solution): pure

Duration of treatment / exposure:
4 hours
Observation period:
viability/mortality: Daily from acclimatization of the animals to the termination of test
cinical signs: daily from acclimatization of the animals to the termination of test
body weights: at start of acclimatization, on the day of application and at termination of observation
Number of animals:
3 animals
1 male and 2 female
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 h


SCORING SYSTEM: The skin reaction was assessed according to the numerical scoring system listed in the
Commission Directive 2004/73/EC, April 29, 2004

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
animal #25, male
Time point:
other: 24 hours
Score:
ca. 2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
animal #26, female
Time point:
other: 24 hours
Score:
ca. 3
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
animal #27, female
Time point:
other: 24 hours
Score:
ca. 2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
animal #25, male
Time point:
other: 1 hour
Score:
ca. 2
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
animal #26, female
Time point:
other: 24 hours
Score:
ca. 2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
animal #27, female
Time point:
other: 24 hours
Score:
ca. 2
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
See remarks on results
Other effects:
No other effects

Any other information on results incl. tables

Skin irritation scores - individual mean values after 24, 48 and 72 hours:

 animal number  sex  erythema  N  oedema  N
 25  M  1.33  3  0.33  3
 26  F  2.67  3  2.00  3
 27  F  1.33  3  0.67  3

N = number of available data points

Skin irritation scores - assessment according to EEC guidelines

 evaluated intervals  erythema  oedema
 24 hours not irritating         not irritating      
 48 hours
 72 hours

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Based upon the referred classification criteria (Commission Directive 2001/59EC of August 2001), Dihydro-C14-Aldehyde is considered to be
"not irritating" to rabbit skin
Executive summary:

The primary skin irritation potential of Dihydro-C14 -aldehyde was investigated according to OECD test guideline no. 404. The test was applied by topical semi-occlusive application of 0.5 ml to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours, as well as 7, 10 and 14 days after removal of the dressing.

The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, seperately. The mean erythema/eschar score of the three animals was 1.33, 2.67 and 1.33, respectively and the mean oedema score was 0.33, 2.00 and 0.67, respectively.

The application of Dihydro-C14 -aldehyde to the skin resulted in mild to moderate, earlyonset and transient signs of irritation such as erythema, oedema and scaling. These effects were reversible and were no longer evident 14 days after tretment, the end of the observation period for all animals. The test item caused no staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed. Thus, the test item did not induce significant or irreversible damage to the skin.

Based upon the referred classification criteria (Commission Directive 2001/59EC of August 2001), Dihydro-C14-Aldehyde is

considered to be "not irritating" to rabbit skin.