Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Deviations:
no
Principles of method if other than guideline:
0.5 ml under gauze dressing to the clipped intact skin of adult albino rabbits for a period of 4 hr with observations for erythema and edma at 4, 24, 48 and 72 hr. Score of 5 or more is considered a primary irritant.
GLP compliance:
yes
Specific details on test material used for the study:
Ken-React KR TTS
Lot R-1082S
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 hr.
Observation period:
4, 24, 48 and 72 hr
Number of animals:
6
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0.3
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Remarks on result:
no indication of irritation
Other effects:
Non observed

E

   Erythema & Eschar          
 Animal #  1  2  3  4  5  6
 4 hr  1  1  1  1  1
 24 hr  1  1  1  0  0  0
 48 hr  0  0  0  0  0  0
 72 hr  0  0  0  0  0  0

Edema score

0 for animals during the test.

Interpretation of results:
GHS criteria not met
Conclusions:
The target substance is not irritating to skin with irritation score of 0.3.
Endpoint:
skin corrosion: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Justification for type of information:
As there is an in vivo study available, the in vitro study is not needed.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
GLP compliance:
yes
Specific details on test material used for the study:
Ken-React KR TTS Lot 22059
Reddish-brown liquid
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
1 hr
Observation period (in vivo):
24, 48, 72 hr
Number of animals or in vitro replicates:
3 animals. 1 male, 2 females
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 hr
Score:
ca. 10
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
ca. 0.7
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
ca. 0
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
ca. 0
Interpretation of results:
GHS criteria not met
Conclusions:
The target substance is classified as minimally irritating to the eye.
Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Justification for type of information:
As there is an in vivo study available, the in vitro study is not needed.
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

Two in vivo studies were available for the target substance and both indicated non-irritant to skin and eyes (Prince, 1986, & Wnorowski 2003). The hydrolysis product isostearic acid also produced no significant skin or eye irritation in Draize rabbit irritation tests (CIR, 1983).

Based these findings, there is no need to classify the target substance as irritant to skin and eyes.