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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:
72 hours
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Commision Directive: 84/449/EEC 1984
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report):
- Molecular formula (if other than submission substance):
- Molecular weight (if other than submission substance):
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type:
- Physical state:
- Analytical purity:
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.:EU-SMG01695
- Expiration date of the lot/batch:
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions:
- Storage condition of test material:
- Other:

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Healthy female New Zealand White rabbits were obtained from Froxfield Farms (UK) Ltd, Froxfield, Hampshire, and on arrival animals were identified with metal ear tags. Animals were allowed an acclimatisation period of at least five days.
The rabbits were individually housed in grid bottomed metal cages. An antibiotic-free rabbit diet (SQC Standard rabbit pellets produced by Special Diets Services, With am, Essex) and mains drinking water via an automatic watering system were freely available. Certificates of analysis for both diet and drinking water are held on file at Toxicol laboratories.

The rabbit holding room was air conditioned with temperature in the range 17-20 deg. C and relative humidity in the range 37-51% during the acclimatisation and study periods.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5g
- Concentration (if solution):

VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 female
Details on study design:
One hour after the removal of the patches and test article, the treated sites were assessed for signs of reaction to treatment. Similar examinations were made 24, 48 and 72 hours after patch removal.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean
Time point:
24/48/72 h
Score:
0.3
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Irritant / corrosive response data:
1 hour observation
Rabbit number Erythema Oedema Comments
660 0 0 None
677 0 0 None
678 1 0 None
24 hour observation
Rabbit number Erythema Oedema Comments
660 0 0 None
677 0 0 None
678 1 0 None
48 hour observation
Rabbit number Erythema Oedema Comments
660 0 0 None
677 0 0 None
678 0 0 None
72 hour observation
Rabbit number Erythema Oedema Comments
660 0 0 None
677 0 0 None
678 0 0 None

Other effects:
none

Any other information on results incl. tables

Mean scores for erythema and oedema (calculated from the values recorded at the 24,48 and 72 hour readings) were used.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a GLP study according to EEC Commission Directive 91/325/EEC of 1st March 1991, MEA Polyborate 1:1 is not irritating to New Zealand White rabbits.
Executive summary:

The purpose of this study was to assess the degree of irritation produced by the test article when applied to the skin of the albino rabbit. The procedures e used were in accordance with EEC Annex V guidelines.

A 0.5 aliquot of the test article was applied over a previously clipped area of about 6 sq cm of the dorsal skin of each of 3 albino rabbits. The test article was held in contact with the skin, under a semi-occlusive patch assembly, for a 4 hour period. The patches were then removed and skin reaction assessed after one, 24, 48 and 72 hours.

The treated site on 2 of the 3 rabbits remained free from apparent irritation throughout the 72-hour observation period. A barely perceptable erythema was noted at the treated site on the third animal one and 24 hours after patch removal but was no longer apparent at the 48- and 72 - hour examinations.

The test article did not produce significant irritation in any animal.

According to the criteria described in EEC Commission Directive 91/325/EEC of 1st March 1991, the test article would not require labelling with either of the risk phrases "R34 Causes burns" or "R38 Irritating to skin" under the conditions of this study.