Registration Dossier

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study, but no information on purity of test substance.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1984
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Remarks:
Forsvarets Forskningsanstalt

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
SOURCE: EKA AB
PURITY: Not reported
IMPURITY/ADDITIVE/ETC.: Not reported
ANY OTHER INFORMATION: 53.5 wt% Sodium Silicate in water. Molecular weight 158, pH 12.8, liquid, molar ratio 1.6. Classification "corrosive" according to Swedish standards

Test animals

Species:
rabbit
Strain:
other: White Landrace
Details on test animals and environmental conditions:
TEST ANIMALS: 
- Source: Dörröds Djur -och Foderservice, Veberöd 
- Weight at study initiation: 2.7 kg (average) 

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 g/mL applied
Concentration: 53.5 wt% in water
Duration of treatment / exposure:
4 hour(s)
Observation period:
One week for animals with no lesions and 14 days for animals with wounds.
Number of animals:
3
Details on study design:
- Removal of test substance with water after 4 hrs exposure
- Scoring system: skin irritation index, according to OECD 404. 
- Examination time points: 1, 24, 48 and 72 hours

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Time point:
other: 24, 48, 72 h
Score:
8
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
observation for 14 d
Remarks on result:
probability of severe irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
observation for 14 d
Remarks on result:
probability of severe irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
observation for 14 d
Remarks on result:
probability of severe irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
observation for 14 d
Remarks on result:
probability of severe irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
observation for 14 d
Remarks on result:
probability of severe irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
observation for 14 d
Remarks on result:
probability of severe irritation
Other effects:
All exposed animals showed an acute necrosis. The necrosis and an acute oedema outside the wound remained during the following examinations.

Any other information on results incl. tables

AVERAGE SCORE: 
- Erythema: 4
- Edema: 4

No further details on "results" available.


Applicant's summary and conclusion

Interpretation of results:
Category 1 (corrosive) based on GHS criteria