Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Justification for type of information:
See Read-across justification attached.
Data on the reaction mass itself are not available. Therefore the data on each component are used. Sodium carbonate, sodium sulfate and sodium chloride are not classified for skin irritation. Therefore the reaction is considered to be not irritating to skin and therefore it is not classified for this endpoint. Scores available for each component are reported in the field below.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1954
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study was conducted prior to GLP and test guidelines, but sufficient data are available for interpretation of results
Qualifier:
no guideline available
Principles of method if other than guideline:
None
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
No data
Type of coverage:
not specified
Preparation of test site:
other: intact and abraded
Vehicle:
water
Remarks:
for 5%, 10%, 20% and 50 % NaCl solution
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Concentration (if solution): 5%, 10%, 20% and 50 % and 100% NaCl
Duration of treatment / exposure:
No data
Observation period:
No data
Number of animals:
No data
Details on study design:
Please see the table below.
Irritation parameter:
other: The following responses were observed: reddening skin, presence or absence of edema, of necrosis and of scarbs.
Basis:
other: Not specified
Time point:
other: Not specified
Reversibility:
not specified
Remarks on result:
probability of weak irritation
Irritant / corrosive response data:
When in contact with the intact skin, sodium chloride causes no response, either in undiluted form or in solution. However, abraded skin may be appreciably irritated depending upon the concentration of the salt solution. Strong solutions (20% or better) result in scab and scar formation after a few applications. Weaker solutions (10% or 5%) produce slight irritation which delays healing without scarring.
Other effects:
None

None

Interpretation of results:
GHS criteria not met
Conclusions:
When in contact with the intact skin, sodium chloride causes no response, either in undiluted form or in solution. However, abraded skin may be appreciably irritated depending upon the concentration of the salt solution. Strong solutions (20% or better) result in scab and scar formation after a few applications. Weaker solutions (10% or 5%) produce slight irritation which delays healing without scarring.
Executive summary:

When in contact with the intact skin, sodium chloride causes no response, either in undiluted form or in solution. However, abraded skin may be appreciably irritated depending upon the concentration of the salt solution. Strong solutions (20% or better) result in scab and scar formation after a few applications. Weaker solutions (10% or 5%) produce slight irritation which delays healing without scarring.

Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1960
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study was conducted prior to GLP and test guidelines.
Qualifier:
no guideline available
Principles of method if other than guideline:
None
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
No data
Type of coverage:
not specified
Preparation of test site:
other: intact and abraded
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
Undiluted as well as 10% aqueous solution was applied to the rabbit's skin.
Duration of treatment / exposure:
Duration varied from 3 to 10 applications.
Observation period:
21 days
Number of animals:
No data
Details on study design:
TEST SITE
- Area of exposure: Belly and ear
Irritation parameter:
other: The following responses were observed: absence or presence of hyperemia, edema and necrosis.
Basis:
other: Not specifed
Time point:
other: Not specified
Reversibility:
fully reversible within: 21 days
Remarks on result:
probability of weak irritation
Irritant / corrosive response data:
Please see the table above
Other effects:
None

None

Interpretation of results:
GHS criteria not met
Conclusions:
To intact skin, undiluted sodium chloride (wet patch) induces slight edema. Dry undiluted sodium chloride induces very slight edema and 10% aqueous solution induces no irritation to skin.
Executive summary:

Undiluted Cubidow is slightly to moderately irritating to intact and abraded skin. Contact for a short period of time would probably result in no appreciable irritation. Skin contact on a prolonged basis, particularly in the case of moist or wet skin and if confined to the surface as exemplified by contaminated gloves or clothing in general, might produce some reddening. If the material were allowed to remain in contact on a continuous basis for a day or two, it is likely that a slight skin burn might result, particularly if the skin were abraded or was otherwise abnormal as exemplified by skin rashes, etc.

However to intact skin, very slight or slight irritation were seen with pur substance. No irritation was induced with a10% aqueous solution.

Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The report contains sufficient information to permit a meaningful evaluation of study results.
Qualifier:
no guideline available
Principles of method if other than guideline:
The study methodology followed was equivalent or similar to OECD 404.
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
not specified in the report
Type of coverage:
not specified
Preparation of test site:
other: intact and abraded skin
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
50 mg dry powder moistened with 0.1 ml water
Duration of treatment / exposure:
single exposure
Observation period:
72 hours
Number of animals:
6 rabbits
Details on study design:
not specified in the report
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0.88
Max. score:
8
Reversibility:
fully reversible within: 72 hours
Remarks on result:
probability of weak irritation
Irritant / corrosive response data:
The overall irritation score was 0.88 out of a maximum score of 8
Other effects:
not specified in the report

not applicable

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results, sodium chloride is slightly irritating to rabbit skin but it is not classified as irritating to skin according to UN and EU GHS criteria.


Executive summary:

A primary skin irritation study was conducted in rabbits on intact and abraded skin and based on the results, sodium chloride induce slight irritation to rabbit skin which is fully reversible within 72h. Therefore sodium chloride is not classified for skin irritation according to UN and EU GHS criteria.

 

Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-compliant guideline study with minor deviations, fully adequate for assessment. In the OECD SIDS on sodium carbonate (2002) a similar reliability was assigned.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Test substance was not moistened with water ; patch was occlusive instead of semi-occlusive. Minor deviations included small differences in housing conditions and no other toxic effects have been observed.
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS:
- Sex: Not reported.
- Source: Harald Schriever, Rabbit farm, Germany.
- Age: Not reported.
- Weight at study initiation: 2.4 - 2.6 kg.
- Number of animals: 6
- Controls: Included but not described.
Type of coverage:
occlusive
Vehicle:
other: other
Amount / concentration applied:
Concentration: 0.5 g
Duration of treatment / exposure:
4 hour(s)
Number of animals:
6
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Other effects:
No
Interpretation of results:
GHS criteria not met
Conclusions:
Classification: not irritating for skin.
Executive summary:

In a test performed according to OECD test guideline 404, 0.5 gr of sodium carbonate was applied on the skin of New Zealand White Rabbits. The scores are the following: Erythema score = 0 (24/48/72h). Edema score = 0 (24/48/72h). Based on these results, sodium carbonate is not considered to be irritating to skin.

 

Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Type of coverage:
occlusive
Vehicle:
other: polyetyleneglycol 400
Amount / concentration applied:
Concentration: 500 mg
Duration of treatment / exposure:
4 hour(s)
Number of animals:
3
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0

RS-Freetext:
AVERAGE SCORE
- Erythema: score = 0, after 14 days
- Edema: score = 0 after 14 days
REVERSIBILITY: not described
OTHER EFFECTS: Irrit. index : edema = 0.0; erytheme = 0.0.
Body weight, 3.7 - 4.2 kg

Interpretation of results:
GHS criteria not met
Conclusions:
Classification: not irritating for skin.
Executive summary:

In a test performed according to OECD test guideline 404, 500 gr of sodium carbonate was applied on the skin of New Zealand White Rabbits. The scores are the following: Erythema score = 0 (24/48/72h). Edema score = 0 (24/48/72h). Based on these results, disodium sulfate is not considered to be irritating to skin.

 

Data source

Materials and methods

Test material

Constituent 1
Chemical structure
Reference substance name:
pentasodium chloride carbonate sulfate
EC Number:
908-570-0
Molecular formula:
not applicable - multi-constituent substance
IUPAC Name:
pentasodium chloride carbonate sulfate

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24h and 72h
Score:
0.88
Reversibility:
fully reversible within: 72h
Remarks on result:
other:
Remarks:
NaCl
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
fully reversible
Remarks on result:
other: Sodium sulfate
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Sodium sulfate
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Sodium carbonate
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Sodium carbonate

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The reaction mass is not irritant for skin based on the data on the three components.

Categories Display