Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
At this time an In-vivo study was performed and therefore covers this endpoint.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to OECD Guideline 404.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Hoechst AG, conventional breeding- Age at study initiation: 3 - 5 month- Weight at study initiation: 2.7 - 3.3 kg- Housing: individual in stainless steel cages- Diet (e.g. ad libitum): ad libitum- Water (e.g. ad libitum): ad libitum- Acclimation period: at least 5 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 20 +/- 3°C- Humidity (%): 50 +/- 20 %- Air changes (per hr): 15- Photoperiod (hrs dark / hrs light): 12 hour interval

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL of undiluted test item
Duration of treatment / exposure:
1 hour respectively 4 hours
Observation period:
The evaluation was carried out 30 - 60 min and 24, 48 and 72 hours as well as 7, 14 and 21 days after the removal of the patch.
Number of animals:
1 hour of exposure: 3 animals4 hours of exposure: 3 animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
1 hour exposure
Basis:
mean
Remarks:
all animals
Time point:
other: 24 / 48 / 72 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Remarks:
1 hour exposure
Basis:
animal #1
Remarks:
mean
Time point:
other: 24 / 48 / 72 hours
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Remarks:
1 hour exposure
Basis:
animal #2
Remarks:
mean
Time point:
other: 0.67
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
1 hour exposure
Basis:
animal #3
Remarks:
mean
Time point:
other: 24 / 48 / 72 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Remarks:
1 hour exposure
Basis:
mean
Remarks:
all animals
Time point:
other: 24 / 48 / 72 hours
Score:
0.1
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Remarks:
1 hour exposure
Basis:
animal #1
Remarks:
mean
Time point:
other: 24 / 48 / 72 hours
Score:
0.1
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Remarks:
1 hour exposure
Basis:
animal #2
Remarks:
mean
Time point:
other: 24 / 48 7 72 hours
Score:
0
Max. score:
0
Irritation parameter:
edema score
Remarks:
1 hour exposure
Basis:
animal #3
Remarks:
mean
Time point:
other: 24 / 48 / 72 hours
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Remarks:
4 hour exposure
Basis:
mean
Remarks:
all animals
Time point:
other: 24 / 48 / 72 hours
Score:
2.44
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
erythema score
Remarks:
4 hour exposure
Basis:
animal #1
Remarks:
mean
Time point:
other: 24 / 48 / 72 hours
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
erythema score
Remarks:
4 hour exposure
Basis:
animal #2
Remarks:
mean
Time point:
other: 24 / 48 / 72 hours
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
erythema score
Remarks:
4 hour exposure
Basis:
animal #3
Remarks:
mean
Time point:
other: 24 / 48 / 72 hours
Score:
2.3
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
edema score
Remarks:
4 hour exposure
Basis:
mean
Remarks:
all animals
Time point:
other: 24 / 48 / 72 hours
Score:
0.67
Max. score:
2
Reversibility:
fully reversible
Remarks:
14 days
Irritation parameter:
edema score
Remarks:
4 hour exposure
Basis:
animal #1
Remarks:
mean
Time point:
other: 24 / 48 / 72hours
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Remarks:
4 hour exposure
Basis:
animal #2
Remarks:
mean
Time point:
other: 24 / 48 / 72 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Remarks:
4 hour exposure
Basis:
animal #3
Remarks:
mean
Time point:
other: 24 / 48 / 72hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
4 hour exposure: Scare formation in one animal, no full revesibility in all animals after 21 days

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the test results of this study, the test material is considered to be corrosive to rabbit skin.
Executive summary:

The registration substance was tested in a GLP conform study for skin irritation / corrosion according to OECD test guideline 404. For this 0.5 mL of undiluted test material was applied semi-occlusively for 1 hour or 4 hours to the shaved skin of three New Zealand White rabbits per exposure period. The skin then was examined 30 minutes, 1 hour, 24, 48 and 72 hours after removal of the dressing. Since effects were still present after 72 hours, additional readings were performed after 7, 14 (1 hour exposure group) and 21 days (4 hour exposure group).

Results for the 60 minute exposure period (3 animals): From 30 minutes to 14 days after patch removal, the treated skin sites showed mild to moderate erythema and mild to strong oedema. Between 24 hours and 14 days, the treated skin areas were cracked, dry-brittle, and scaly. Additionally scaling was observed. All signs of irritation were reversible.

Results for the 4 hour exposure period (3 animals): From 30 minutes to 21 days after application, the skin was temporarily sclerotic, vaulted, encrusted, scabby, white and brown-white discoloured. Additionally, skin induration was noted in two animals 21 days post exposure. In the remaining animal full thickness destruction of the epidermis occurred after 21 days.

Based on the results of this study, the test item was corrosive to rabbit skin.