Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

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:
Comparable to guideline study reliable with restrictions. Minor deviations with no effect on the results: - Purity and stability was missing - According to guideline, 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 8 days after start of exposure. -The narrative desciption of the degree and nature of irritation observed is missing

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
, adopted 1981-05-12
Deviations:
yes
Remarks:
, see "rationale for reliability"
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report):Natriumsulfit wasserfrei Z
- Expiration date of the lot/batch: September 1983
No further information on the test substance was stated.

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Firma Gaukler; 6050 Offenbach/Main
- Weight at study initiation: Mean weight males: 3.03 kg; mean weight females: 2.80 kg (Individual weights of the test animals: 3.26 kg (male); 2.98 kg (female); 2.79 kg (male); 2.62 kg (female))
- Housing: The animals were housed individually; Cage made of stainless steel with wire mesh walk floor, floor area: 40 cm x 51 cm; No bedding in the cages; sawdust in the waste trays
- Diet: Ovator Solikanin 4 mm; Muskator-Werke, 4000 Düsseldorf, FRG (about 130 g per animal per day)
- Drinking water: About 250 ml per animal per day: fully demineralized water (Monday - Friday), tap water (Saturday/Sunday)
- Acclimatization period: About 8 days before the beginning of the study in the skin laboratory; same housing conditions as during the study.

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 26°C
- Relative humidity: approx. 30 - 70%
- Photoperiod (hrs dark / hrs light): 12/12
No further information on the test animals was stated.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Applying an approx. 0.5 mm thick layer of the 50 % solution of the test substance (comparable to 0.5 g of the test substance).
No further information on the amount/concentration applied was stated.
Duration of treatment / exposure:
4 hours
Observation period:
8 days; Readings at 30-60 minutes after application as well as at 24 hours, 48 hours and 8 days after start of application
Number of animals:
2 males / 2 females
Details on study design:
TEST SITE
- Area of exposure: 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 was covered with the test substance. In order to prepare the solution distilled water was used. 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: Draize scoring system
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:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: In the raw data no observation for 72 hours was included. Since at the 48 hours reading no skin irritation was observed, it was concluded that it could be safely assumed that no skin irritation was present at the 72 hour reading (erythema = 0).
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: In the raw data no observation for 72 hours was included. Since at the 48 hours reading no skin irritation was observed, it was concluded that it could be safely assumed that no skin irritation was present at the 72 hour reading (oedema = 0).
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24,48, and 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: In the raw data no observation for 72 hours was included. Since at the 48 hours reading no skin irritation was observed, it was concluded that it could be safely assumed that no skin irritation was present at the 72 hour reading (erythema = 0).
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: In the raw data no observation for 72 hours was included. Since at the 48 hours reading no skin irritation was observed, it was concluded that it could be safely assumed that no skin irritation was present at the 72 hour reading (oedema = 0).
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: In the raw data no observation for 72 hours was included. Since at the 48 hours reading no skin irritation was observed, it was concluded that it could be safely assumed that no skin irritation was present at the 72 hour reading (erythema = 0).
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: In the raw data no observation for 72 hours was included. Since at the 48 hours reading no skin irritation was observed, it was concluded that it could be safely assumed that no skin irritation was present at the 72 hour reading (oedema = 0).
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #4
Time point:
other: 24, 48, and 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: In the raw data no observation for 72 hours was included. Since at the 48 hours reading no skin irritation was observed, it was concluded that it could be safely assumed that no skin irritation was present at the 72 hour reading (erythema = 0).
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #4
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: In the raw data no observation for 72 hours was included. Since at the 48 hours reading no skin irritation was observed, it was concluded that it could be safely assumed that no skin irritation was present at the 72 hour reading (oedema = 0).
Irritant / corrosive response data:
At the 8 day reading no erythema or oedema werte observed.
Other effects:
No data

Any other information on results incl. tables

Results:

Readings Animal Erythema Edema Additional findings
24 h 1 1 0  
2 1 0  
3 1 0 overlapping erythema
4 1 0  
48 h 1 0 0  
2 0 0  
3 0 0  
4 0 0  
8 d 1 0 0  
2 0 0  
3 0 0  
4 0 0  
mean 24 - 48 h 1 0.5 0.0  
2 0.5 0.0  
3 0.5 0.0  
4 0.5 0.0  
mean   0.5 0.0  

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Sodium sulphite is not an skin irritant.
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.