Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
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

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
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
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

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.