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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Guideline study reliable with restrictions Minor deviations with no effect on the results: - Purity and stability were not stated. - According to guideline, the observations should be made at 30-60 minutes and at 24, 48, and 72 hours after patch removal and not 24 hours, 48 hours and 72 days after start of exposure. - A modified Draize scoring system was used in this study. - According to the guideline the test substance should be moistened with water. In this study the test patch was moistend with water for application instead of the test substance. - The water supply was not unrestricted. - in the study report it was stated that observations were made at 30-60 minutes after patch removal. In the result table data were listed for an observation at 4-hours.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
, adopted 1981-05-12
Deviations:
yes
Remarks:
, see "rationale for reliability"
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Potassium sulphite
No further information on the test material was stated.

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Savo; Med. Versuchstierzuchten GmbH; 7964 Kisslegg/Allgäu FRG
- Weight at study initiation: mean weight 2.56 kg (Individual weights of the three test animals:2.78 kg, 2.22 kg, and 2.68 kg)
- Housing: The animals were individually housed. The animals were housed in fully air-conditioned rooms. Cage made of stainless steel with wire mesh walk floors. Floor area: 40 cm X 51 cm. No bedding in the cages.Sawdust in the waste trays.
- Diet: Kliba 341, 4 MM; Firma Klingentalmuehle AG, CH- 4303 Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water: About 250 ml tap water per animal per day
- Acclimation period: At least 8 days before the beginning of the study; same housing conditions as during the study.

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 °C
- Relative humidity: 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12
No further information on the test animals was stated.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A dose of 0.5 g of the unchanged test substance.
No further information on the amount/concentration applied was stated.
Duration of treatment / exposure:
4 hours
Observation period:
72 hours; Readings of skin irritation at 30 - 60 minutes after removal of the test patches and 24 h, 48 h and 72 h after the beginning of application.
Number of animals:
3 male rabbits
Details on study design:
TEST SITE
The fur of the rabbits was clipped at least 15 hours before the beginning of the study.The application area was 2.5 cm X 2.5 cm on the upper third of the back or flanks. The test patch (2.5 cm X 2.5 cm) was covered with a dose of 0.5 g of the unchanged test substance and has been moistened with aqua dest.. Test patches were secured in position with a porous dressing (four layers of absorbant gauze and porous bandage). The untreated skin sites of the same animals was used as negative control.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test substance was removed with lutrol and lutrol/water (1:1).
- Time after start of exposure: At the end of the exposure period

SCORING SYSTEM: Modified Draize scoring system
Evaluation of erythema (R) and oedema (ED):
0 = none
1 = very slight
2 = well-defined
3 = moderate to severe
4 = severe to very severe
No further information on the study design was stated.

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
Remarks on result:
other: The readings were made 24 h, 48 h and 72 h after the beginning of application
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: The readings were made 24 h, 48 h and 72 h after the beginning of application
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: The readings were made 24 h, 48 h and 72 h after the beginning of application
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: The readings were made 24 h, 48 h and 72 h after the beginning of application
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: The readings were made 24 h, 48 h and 72 h after the beginning of application
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:
Very slight erythema was observed in two animals at the 4-hour reading, which had disappeared at the 24 hour reading.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No erythema or oedema were seen in any of the rabbits at 24, 48, 72 hours after the beginning of the study.
According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the test item is not classified as skin irritant.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not classified as skin irritant.