Registration Dossier

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
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1971
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
Species:
rabbit
Strain:
other: normal albino
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:
0
Max. score:
0
Remarks on result:
other: For both intact and abraded skin.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Remarks on result:
other: For both intact and abraded skin.
Irritation parameter:
erythema score
Basis:
other: total
Time point:
other: 72 h
Score:
0
Max. score:
0
Reversibility:
no data
Irritation parameter:
edema score
Basis:
other: total score
Time point:
other: 72 h
Score:
0
Max. score:
0
Reversibility:
no data
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72 h
Score:
0
Other effects:
Not specified.
Interpretation of results:
not 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 it can be considered as non-irritant and not sufficient for classification.
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:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: no GLP but the method used was based on scientifically accepted method.
Qualifier:
no guideline followed
Principles of method if other than guideline:
method used was a modified Draize method.
GLP compliance:
no
Species:
rabbit
Strain:
other: New Zeland
Details on test animals or tissues and environmental conditions:
Animals were received from Summit view farm, Belvidere, New Jersey. The animals are fed and watered ad libitum; with wayne animal feeds used exclusively. Text material were applied on intact and abraded skin and was covered with an impermeable occlussive wrapping. The wrapping were removed 24h following application.
Vehicle:
not specified
Controls:
other: the left eye that was untreated served as a control
Amount / concentration applied:
0.1ml per eye
Duration of treatment / exposure:
24h
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Irritation parameter:
overall irritation score
Basis:
other: Total score
Time point:
24/48/72 h
Score:
0
Max. score:
20
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation score
Basis:
other: Total score
Time point:
7 d
Score:
0
Max. score:
20
Remarks on result:
no indication of irritation
Other effects:
no other effect
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test compound is not an ocular irritant.
Executive summary:

The numerical scoring point according to Draize standard scoring was 0. Thus, the test compound is not an ocular irritant.

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

Since the test material produced a primary irritation index for skin of 0 to 0.5, it can be considered as only a very slightly primary irritant and not sufficient for classification. A study with tetradecyl lactate did not induce significant irritation of rabbits eye, implying no reason for classification as an eye irritant.