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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:
1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

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 animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Sutton Bonington, Leicestershire, U.K.
- Age at study initiation: approximately 12-16 weeks old
- Weight at study initiation: 2.49-2.57 kg
- Housing: individually, in suspended metal cages
- Diet: Rabbit Diet (AW Tindall Limited, Holbeach, Lincolnshire, U.K.), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 18-21 °C
- Humidity: 50-65 %
- Air changes: approximately 10 changes/hour
- Photoperiod: 12 hours dark / 12 hours light

IN-LIFE DATES: From: 01-Oct-1985 To: 08-Oct-1985

Test system

Type of coverage:
other: occlusive or semi-occlusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL of undiluted test item
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3 rabbits
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm (area of gauze patch used)
- Type of wrap if used: gauze patch secured in position with adhesive strapping

REMOVAL OF TEST SUBSTANCE
- Washing: gentle swabbing with cotton wool soaked in ether
- Time after start of exposure: 4 hours

SCORING SYSTEM:
Approximately 1, 24, 48 and 72 hour(s) after patch removal, the test sites were examined and scored acording to the scale of Draize. The scores for erythema and oedema at the 24 and 72 hour readings were totalled for the 3 test rabbits (12 values). This total was divided by 6 to give the Primary Irritation Index of the test item. This index was used to classify the skin irritation according to the scheme shown under "Any other information on materials and methods incl. tables".

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: desquamation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 48 hours
Score:
1
Max. score:
4
Remarks on result:
other: desquamation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 72 hours
Score:
1
Max. score:
4
Remarks on result:
other: desquamation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 hours
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 48 hours
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 72 hours
Score:
2
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24 hours
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: desquamation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 48 hours
Score:
2
Max. score:
4
Remarks on result:
other: desquamation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 72 hours
Score:
2
Max. score:
4
Remarks on result:
other: desquamation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 48 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 48 hours
Score:
1
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 72 hours
Score:
1
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 48 hours
Score:
1
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 72 hours
Score:
0
Max. score:
4
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
other: sum of 24 and 72 hour reading / 6
Score:
2.2
Remarks on result:
other: moderate irritant

Any other information on results incl. tables

Well defined erythema accompanied by minimal oedema, with the reactions extending beyond the site of application was noted in 3/3 rabbits at the 1 -hour reading and in 2/3 rabbits at subsequent 24, 48 and 72 -hour observations. The skin irritation had become less marked in one rabbit by the 24 -hour reading when barely perceptible erythema was seen in this animal. In addition, desquamation was noted in 2/3 rabbits at this stage. Similar levels of reaction persisted at subsequent 48 and 72 -hour readings. A reduction in the level of reaction was seen at day 7 when barely perceptible erythema accompanied by desquamation, with the reactions extending beyond the site of application was apparent in the remaining animal at this stage.

Applicant's summary and conclusion

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

In a primary dermal irritation study (Jones & Collier, 1985), 3 young adult New Zealand White rabbits were dermally exposed to 0.5 mL of ZD 8 Gewaschen for 4 hours. Animals then were observed for 7 days. Irritation was scored by the method of Draize (1959). The primary irritation index was used for classification of irritancy.

In this study, ZD 8 gewaschen was a moderate irritant based on well defined erythema accompanied by minimal oedema noted and scored in all rabbits.