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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:
25 February to 1 March 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: Annex V
Qualifier:
according to guideline
Guideline:
other: USFDA Code of Federal Regulations Title 16, Section 1500.41
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 734242, Source Sponsor
- Expiration date of the lot/batch: Not stated
- Purity test date: Not stated
- Appearance: Clear liquid

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark
- Stability under test conditions: Not stated
- Solubility and stability of the test substance in the solvent/vehicle:
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Applied as supplied

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Three male and 3 female New Zealand White rabbits (order weight 2.5 kg-3.0 kg) were used. They were supplied by a Reputable Commercial Supp;ier and arrived at Ithe test site on 17-February 1987. They were housed individually in aluminium cages with grid floors beneath which were peat moss filled trays. They were fed on Special Diet Services Rabbit Diet of satisfactory anaJysis and allowed food and water ad libitum A 12 h light/dark cycle was in operation.

Mean environmental max.imum and minimum temperatures were 17°C and 15°C and mean relative humidity was 60°%.

The animals were allowed an acclimatisation period of 8 days before test commencement.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: two test sites prepared both were shaved and one was also abraded before application.
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5mL
Duration of treatment / exposure:
24 h
Observation period:
24h and 72h after patch application
Number of animals:
6
Details on study design:
The hair was clipped from the back of each rabbit approximately 24 h before treatment.
The test material (0.5 ml} was applied to each rabbit under two 2.5 cm x 2.5 cm patches of gauze. One site was abraded before application using a sterilin blood lancet.
The patches were covered with Blenderm tape and the entire trunk was bound with Sleek occlusive tape which remained in position for 24 h.
At the end of this period the patches were removed and the skin wiped with damp tissues to remove surplus test material.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effects seen
Remarks on result:
no indication of irritation
Remarks:
effects only monitored for 72 hours. 48 h reading not measured.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effects seen
Remarks on result:
no indication of irritation
Remarks:
effects only monitored for 72 hours. 48 h reading not measured.
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effects seen
Remarks on result:
no indication of irritation
Remarks:
effects only monitored for 72 hours. 48 h reading not measured.
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effects seen
Remarks on result:
no indication of irritation
Remarks:
effects only monitored for 72 hours. 48 h reading not measured.
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effects seen
Remarks on result:
no indication of irritation
Remarks:
effects only monitored for 72 hours. 48 h reading not measured.
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effects seen
Remarks on result:
no indication of irritation
Remarks:
effects only monitored for 72 hours. 48 h reading not measured.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effects seen
Remarks on result:
no indication of irritation
Remarks:
effects only monitored for 72 hours. 48 h reading not measured.
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effects seen
Remarks on result:
no indication of irritation
Remarks:
effects only monitored for 72 hours. 48 h reading not measured.
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effects seen
Remarks on result:
no indication of irritation
Remarks:
effects only monitored for 72 hours. 48 h reading not measured.
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effects seen
Remarks on result:
no indication of irritation
Remarks:
effects only monitored for 72 hours. 48 h reading not measured.
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effects seen
Remarks on result:
no indication of irritation
Remarks:
effects only monitored for 72 hours. 48 h reading not measured.
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: 24/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effects seen
Remarks on result:
no indication of irritation
Remarks:
effects only monitored for 72 hours
Irritant / corrosive response data:
No irritation was noted after a 24 h occluded exposure to MBD.

The primary irritation score for MBD cream was calculated to be 0.

Other effects:
None.

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
No irritant responses were noted following a 24 h exposure to MBD The primary irritation score was calculated to be O and as such MBD is not classified as a primary skin irritant.