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
Remarks:
Result are from an in-vivo study performed in 1970, i.e. before the in vitro skin irritation requirement.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1970
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The test is non-GLP but the parameters documented partially comply with a specific testing guideline.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Observations only after 24 and 72 h.
Principles of method if other than guideline:
The irritation index is based on the Draize method in this study. Presently, this method is no longer used for determination of the degree of irritation.
GLP compliance:
no
Specific details on test material used for the study:
Product Ceraphyl®31
Species:
rabbit
Strain:
other: normal albino
Details on test animals and environmental conditions:
Not specified.
Type of coverage:
occlusive
Preparation of test site:
other: Clipped with minor abrasions
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
24
Observation period:
At the end of the 24-hour period and 48 hours later. Scoring of irritation according to the method of Draize.
Number of animals:
3
Details on study design:
0.5 ml test substance applied on the scarified and 0.5 ml on non-scarified area, which were covered with Webril patches. Animals were immobilized in racks for the 24-hour period.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24
Score:
1
Max. score:
1
Remarks on result:
other: Intact and abraded skin: score 1 means very slight and barely perceptible.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72
Score:
0
Max. score:
1
Remarks on result:
other: Intact skin: 0; abraded skin: 1
Irritation parameter:
erythema score
Basis:
other: total
Time point:
other: 72 h
Score:
2
Max. score:
2
Reversibility:
other: Reversible at 72h
Irritation parameter:
edema score
Basis:
other: total score
Time point:
other: 72 h
Score:
0
Max. score:
0
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72 h
Score:
0.3
Other effects:
Not specified.
Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Scoring according to Draize
Conclusions:
Since the test material produced a primary irritation index of 0.3, it can be considered as a mild primary irritant and not sufficient for classification.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Remarks:
Results are from an in-vivo study performed in 1976, i.e. before the in vitro eye irritation requirement.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The test is non-GLP but the parameters documented partially comply with a specific testing guideline.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Federal Hazardous Substances Labelling Act.
GLP compliance:
no
Specific details on test material used for the study:
Product name: Ceraphyl 31
Species:
rabbit
Strain:
not specified
Vehicle:
other: corn oil
Controls:
not required
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
7 days
Observation period (in vivo):
Every 24 hours for foour days and on the seventh day.
Number of animals or in vitro replicates:
6
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: all
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: all
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: all
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: all
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: all
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: all
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: all
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: all
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
hyperemia
Basis:
animal #3
Time point:
other: 24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 48h - day 7
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
other: all
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #4
Time point:
other: all
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: all
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
other: all
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #5
Time point:
other: all
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
hyperemia
Basis:
animal #5
Time point:
other: 24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
other: 48 h - day 7
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
other: all
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #6
Time point:
other: all
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: all
Score:
0
Max. score:
0
Other effects:
Not recorded.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Installation of 0.1 ml of the test material into the eyes of six rabbits produced a primary irritation index of 0.1. Hence, the substance was not irritant for the rabbit's eye. Thus, not sufficient for classification.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The studies on skin irritation show Draize primary irritation index of 0.3. According to Draize, values less than 2 should be considered as non- to mildly irritating while that of eye irritation produced a primary irritation index of 0.1. Hence, the substance was not irritant for the rabbit's eye. Thus, not sufficient for classification.


Justification for selection of skin irritation / corrosion endpoint:
the study is reliable/ although pre-GLP

Justification for selection of eye irritation endpoint:
the study is reliable/ although pre-GLP

Effects on skin irritation/corrosion: slightly irritating

Justification for classification or non-classification