Registration Dossier
Registration Dossier
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EC number: 212-073-8 | CAS number: 759-94-4
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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: This animal study is not performed according to GLP, but the test parameters are well documented and scientifically acceptable.
- Qualifier:
- according to guideline
- Guideline:
- other: Draize, J.H , Woodard, G., Calvery, H.O. (1944) J.Pharmacol. Expt. Ther. 82, 377-390
- Principles of method if other than guideline:
- Draize, J.H , Woodard, G., Calvery, H.O. (1944) J.Pharmacol. Expt. Ther. 82, 377-390
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: New Zealand albino
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- not specified
- Observation period:
- 24 h and 72 h
- Number of animals:
- 2
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 and 72 h mean
- Score:
- ca. 4.75
- Max. score:
- 7
- Reversibility:
- no data
- Remarks on result:
- other: moderately irritating
- Irritation parameter:
- edema score
- Remarks on result:
- other: PDII=7
- Remarks:
- PDII=7
- Irritation parameter:
- erythema score
- Remarks on result:
- other: PDII=7
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information H315 Criteria used for interpretation of results: EU
- Conclusions:
- The EPTC substance is reported to be moderately irritative ( mérsékelten irritatív) according to Draize scoring system. H 315 bőrirritáció 2. kategória
- Executive summary:
The EPTC substance is reported to be moderately irritative ( mérsékelten irritatív). H 315 Bőrirritáció 2. kategória
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This animal study is not performed according to GLP, but the test parameters are well documented and scientifically acceptable.
- Qualifier:
- according to guideline
- Guideline:
- other: Draize, J.H , Woodard, G., Calvery, H.O. (1944) J.Pharmacol. Expt. Ther. 82, 377-390
- Principles of method if other than guideline:
- Draize, J.H , Woodard, G., Calvery, H.O. (1944) J.Pharmacol. Expt. Ther. 82, 377-390
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: New-Zealand albino
- Vehicle:
- not specified
- Controls:
- not specified
- Observation period (in vivo):
- 24 h, 48 h, 72 h
- Number of animals or in vitro replicates:
- 2
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: mean 24, 48 and 72 h
- Score:
- ca. 48.7
- Max. score:
- 70
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Remarks on result:
- other: Overall irritation score 70
- Remarks:
- Overall irritation score 70
- Irritation parameter:
- conjunctivae score
- Remarks on result:
- other: Overall irritation score 70
- Remarks:
- Overall irritation score 70
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information H 319 Szem irit cat 2 Criteria used for interpretation of results: EU
- Executive summary:
The EPTC substance is reported to be moderately irritative ( mérsékelten irritatív). H 319 Szemirritáció 2. kategória
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Justification for selection of skin irritation / corrosion endpoint:
Primer irritativ érték (PDII): 4.75
Justification for selection of eye irritation endpoint:
Avarage of 24, 48 & 72 h observations: 48.7
Effects on skin irritation/corrosion: moderately irritating
Effects on eye irritation: moderately irritating
Justification for classification or non-classification
H 315 Bőr irrit cat 2.
H 319 Eye irrit cat 2.
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