Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Skin irritation:


The test item was found not to be irritating to the skin.


Eye irritation:


As the grade of the irritant effect was too low, the test item in the formulation tested has not to be classified as irritant (H 319). Likewise, a risk of serious damage to the eyes could be excluded (H 318). 

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
Study period:
2009-11-16 - 2010-02-10
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
physiological saline
Controls:
other: The untreated skin of each animal served as control.
Amount / concentration applied:
The maximum concentration possible was used in the film, because administration of a dose of 0.5 g or 0.5 ml per animal are listed in the guideline. One film of C16 (containing approx. 42.5 mg C16) was applied to the skin of the experimental animals.
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 males
Details on study design:
Patch testing was used to detect primary irritating effects of the test item.
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
5
Interpretation of results:
GHS criteria not met
Conclusions:
The test item was found to be not irritating to the skin.
Executive summary:

The test item was found to be not irritating to the skin.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009-11-19 - 2010-02-05
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Vehicle:
other: pyrogenfree HEPES buffer
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml of the test item (corresponding to a dose of 0.3 mg/animal)
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 12 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
3
Irritation parameter:
iris score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
2
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Interpretation of results:
GHS criteria not met
Conclusions:
The test item did not cause any signs of pain reaction or any clinical findings.
Executive summary:

The test item did not cause any signs of pain reaction or any clinical findings.


 

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on the study data for skin and eye irritation the substance is not to be classified for skin and eye irritation.