Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: no GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Patch Test Rabbit - Code of Federal Regulations, Title 16, Section 1500.41
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
-Name of the test material : p-Chlorobenzaldehyde, pure

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: W. OStrup / Meerbuch
- Weight at study initiation: average 2.4 kg
- Diet (ad libitum): mümmel z (ssniff / Soest)
- Water (ad libitum): yes
- Acclimation period: 7- 14 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18 °C
- Humidity (%): 40
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved or shaved + scratched
Vehicle:
other: oil
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 500 mg in oil
Duration of treatment / exposure:
24 h
Observation period:
8 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100
- Type of wrap if used: 5 x 5 cm impermeable foil (PVC) + Eloflex tape



SCORING SYSTEM:

- according to Draize

Scores for erythema and edema fr intact and scratched skin after 24 and 72 hours were averaged.
The resultig means divided by 4 result in the primary irritating index fot the skin..

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
(intact and scratched skin of 6 animals)
Time point:
other: 24 h and 72 h
Score:
5.2
Max. score:
8
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: classified as highly irritating
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #1
Time point:
other: 24 and 72 h
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #2
Time point:
other: 24 and 72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #3
Time point:
other: 24 and 72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #4
Time point:
other: 24 and 72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #5
Time point:
other: 24 and 72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
animal #6
Time point:
other: 24 and 72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #1
Time point:
other: 24 and 72 h
Score:
3.5
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #2
Time point:
other: 24 qnd 72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #3
Time point:
other: 24 qnd 72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #4
Time point:
other: 24 and 72 h
Score:
3.5
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #5
Time point:
other: 24 and 72 h
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
animal #6
Time point:
other: 24 and 72 h
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 8 days

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information
Executive summary:

In a dermal irritation study (FhG 1980) six New Zealand White rabbits were dermally exposed to undiluted p-Chlorobenzaldehyde in oil. The test site (intact or scratched dorsal skin) was covered with an occlusive dressing for 24 hours. Rabbits then were observed for 8 days. Irritations regarding erythema and edema were scored according to the Draize system after 24 and 72 hours. The test item p-Chlorbenzaldehyde exhibited a highly irritating potential in this study (after 24 h exposure with occlusive conditions), but it seems to be unlikely that the substance would be corrosive after a 4 h semiocclusive treatment according to OECD Guideline 404.

Primary dermal irritation index (6 animals): 5.2 (highly irritating)