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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
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 or test system 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
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