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
Study period:
Jusqu'à 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Referenceopen allclose all

Reference Type:
other: Authority assessment report
Title:
Unnamed
Year:
1993
Reference Type:
secondary source
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Specific details on test material used for the study:
Non disponible

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
Non disponible

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Non communiqué
Duration of treatment / exposure:
4 heures
Observation period:
14 jours
Number of animals:
6 (3 mâles et 3 femelles)
Details on study design:
Non communiqué

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible
Remarks on result:
probability of mild irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible
Remarks on result:
probability of mild irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible
Remarks on result:
probability of mild irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible
Remarks on result:
probability of mild irritation
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Reversibility:
other: Pas applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Reversibility:
other: Pas applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Reversibility:
other: Pas applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Reversibility:
other: Pas applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Reversibility:
other: Pas applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Reversibility:
other: Pas applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Reversibility:
other: Pas applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Reversibility:
other: Pas applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
24 et 48 h aprèsr exposition 4 lapins sur 6 ont développé un léger erythème
pas d'irritation jusqu'au jour 3
Other effects:
Aucun

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Les résultats de cette étude suggèrent une classification de la partie inorganique de la substance à enregistrer (Fer trivalent Fe3+ testé sous forme de sulfate ferrique (Fe3(SO4)3) selon le règement CLP en tant que substance irritante pour la peau de catégorie 2.