Registration Dossier
Registration Dossier
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EC number: 237-853-5 | CAS number: 14024-18-1
Skin irritation / corrosion
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:
- 1 993
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Ferric sulphate anhydrous
- IUPAC Name:
- Ferric sulphate anhydrous
- Reference substance name:
- Diiron tris(sulphate)
- EC Number:
- 233-072-9
- EC Name:
- Diiron tris(sulphate)
- Cas Number:
- 10028-22-5
- Molecular formula:
- Fe2(SO4)3
- IUPAC Name:
- diiron tris(sulphate)
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Non disponible
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system 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.
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