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Description of key information

Skin irritation/ corrosion: Key study (001). Test method according to the OECD 404 and 92/69/EWG, B.4 Guideline. GLP Study.

Skin irritation/ corrosion: Key study (002). Test method according to the 92/69/EWG, B.4. GLP study.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation / corrosion, other
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1992
Qualifier:
according to
Guideline:
other: 92/69/EWG, B.4.
GLP compliance:
yes
Control samples:
yes, concurrent vehicle
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Vehicle:
other: Distilled Water
Amount / concentration applied:
500mg
Duration of treatment / exposure:
4h
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
( mean score 3)
Time point:
24/48/72 h
Score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Max. duration: 21; Max. value at end of observation period: 4 (related to all animals)
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Max duration: 21d; Max. value at end of observation period: 2 (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes not fully reversible within 21 days.
Other effects:
One animal died on day 19, but there was no indication of substance relationship.
Interpretation of results:
other: Corrosive
Remarks:
Migrated information criteria used for interpretation of results: EU
Conclusions:
Test substance, after 72h, was classified as corrosive with not fully reversibility of observed effects.
Executive summary:

A skin irritation/corrosion test was performed according to OECD guideline 404, and 92/69/EWG, B.4 under GLP conditions.

500mg of test substance were administered to three New Zealand White rabbits in semiocclusive conditions using distilled water as a vehicle. Test substance effects were not fully reversible within 21 days.

Regarding the available data, test substance was classified as corrosive.

Endpoint:
skin irritation / corrosion, other
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
other: 92/69/EWG, B.4.
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
SPF
Type of coverage:
semiocclusive
Vehicle:
other: mit Wasser angefeuchtet "ENGLISH" moistened with water
Amount / concentration applied:
500mg
Duration of treatment / exposure:
4h
Number of animals:
3
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
( mean score 3)
Time point:
24/48/72 h
Score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Max. score:
4
Remarks on result:
other: Max. duration: d; Max. value at end of observation period: 4 (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect: Changes not fully reversible within 21 days.
Other effects:
"DEUSTCH"Ein Tier starb 19 Tage nach der Behandlung durch einen Unfall. Der Test wurde durch den Tod des Tieres nicht beeinflußt.Durch die Behandlung mit der Substanz traten auf der behandelten Hautfläche bei allen 3 Kaninchen starke Erytheme und mässige bis starke Ödeme auf. Die Bewertung der Ödeme war bei einem Kaninchen nach 24 Stunden und bei 2 Kaninchen nach 48 Stunden wegen Krustenbildung auf der Haut nicht mehr möglich. Bei Studienabschluss (nach 22 Tagen) war es bei einem Tier möglich die Ödeme zu bewerten.Bei allen Tieren wurden eine Stunde nach der Behandlung Anzeichen von Nekrose festgestellt, welche vernarbtes Gewebe zur Folge hatte. Diese Vernarbung blieb bei den 2überlebenden Tieren bis zum Studienende (Tag 22) bestehen. In keinem der Tiere wurde, während der gesamten Testperiode, durch die Testsubstanz hervorgerufene systemische Toxizität festgestellt."ENGLISH"One animal dies at day 19 due to an accident. Caused by the treatment with the substance strong erythemes and moderate to strong edemae were observed at the treasted skin areas.Evaluating the edemae was not possible in one animal after 24h and in two after 48 h due to crustation of the skin. At the end of the study it was not possible to evaluate the edemae.In all animals necrosis were detected one h after the treatment, which ended up in scared skin.No systemic toxicity was observed.
Interpretation of results:
other: Corrosive
Remarks:
Migrated information criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, the test substance was classified as corrosive
Executive summary:

A skin irritation/corrosion test was performed according to 92/69/EWG, B.4 under GLP conditions.

500mg of test substance were administered to Three New Zealand White rabbits in semiocclusive conditions using distilled water as a vehicle. Test substance effects were not fully reversible within 21 days.

Regarding the available data, test substance was classified as corrosive.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation/ corrosion: Key study (001). Test method according to the OECD 404 and 92/69/EWG, B.4 Guideline. GLP Study. Three New Zealand White rabbits were treated with a single dose of 500mg of test substance in semiocclusive conditions for 4h. The effects of test substance were recorded at 24,48 and 72h. The effects were evaluated according to the edema/erythema scores.

Test substance had corrosive efects on New Zealand White rabbits.

Skin irritation/ corrosion: Key study (002). Test method according to the 92/69/EWG, B.4.GLP study. Three New Zealand White rabbits were treated with a single dose of 500mg of test substance in semiocclusive conditions for 4h. The effects of test substance were recorded at 24,48 and 72h. The effects were evaluated according to the erythema scores. Edema evaluation was not possible due to crustation of skin in animals.

Test substance had corrosive efects on New Zealand White rabbits.


Justification for selection of skin irritation / corrosion endpoint:

Key study 001 provides more detailed information. Key study 002 could not provide edema evaluation due to crustation of skin.

Justification for classification or non-classification

Based on the available information on irritation/corrosion, test substance is classified as skin corrosive.