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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo study
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986-01-16 to 1986-01-19
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline conform study, conducted under GLP principles, with very minor deficiencies when compared to contemporary standards: the purity and the stability of the test material were not stated in the study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981-05-12
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Rezal 67 solution
IUPAC Name:
Rezal 67 solution
Details on test material:
- Name of test material (as cited in study report): Rezal 67 solution
- Label: Ref. QC 751E REZAL 67 SOLUTION
- Physical state: pale straw-coloured liquid
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: approximately twelve to sixteen weeks old
- Weight at study initiation: 2.49 - 2.90 kg
- Housing: the animals were individually housed in suspended metal cages.
- Diet (ad libitum): Rabbit Diet, A.W. Tindall Limited, Holbeach, Lincolnshire, U.K.
- Water (ad libitum): mains drinking water
- Acclimation period: minimum of five days

ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 20°C
- Relative humidity: 45%
- Air exchanges: approximately 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): a quantity of 0.5 mL of the test material
Duration of treatment / exposure:
4 hours
Observation period:
approximately one hour following removal of the patches, and 24, 48 and 72 hours later
Number of animals:
3 rabbits
Details on study design:
TEST SITE
- Area of exposure: approximately twenty-four hours prior to the commencement of the test, each of a group of three rabbits were prepared by closely clipping the fur from the dorsal/flank areas using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.
On the day of the test a suitable test site was selected on the back of each rabbit.
- Type of wrap if used: the test material was introduced under a 2.5 cm X 2.5 cm gauze patch and placed in position on the shorn skin. The patch was secured in position over the test material with two lengths of adhesive strapping (SLEEK) in the form of a cross. To prevent the animals from interfering with the patches the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP) and the animals were returned to their cages for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing: the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: four hours after application

SCORING SYSTEM: according to the Draize scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
No evidence of skin irritation was noted one hour after removal of the patches or at subsequent 24, 48 and 72-hour observation.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material, Rezal 67 Solution, was found to be non-irritant to the rabbit skin.
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test item is not a skin irritant.
According to the EC Regulation No. 1272/2008 and its subsequent amendments, the test item is not a skin irritant.

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