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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The test substance proved non-irritating to rabbit skin and caused only minor, fully reversible reactions in rabbit eyes.

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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Brief report of an open-site skin irritation study, with sufficient information to conclude an effective absence of irritation.
Qualifier:
no guideline followed
Principles of method if other than guideline:
Evaluation of irritant action on intact and abraded skin, using an open test site with immobilisation of test animals.
GLP compliance:
no
Remarks:
Pre-GLP study
Species:
rabbit
Strain:
other: Described as albino rabbits.
Details on test animals or test system and environmental conditions:
No further information available.
Type of coverage:
open
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5g/test site.
Duration of treatment / exposure:
24h
Observation period:
Skin reactions scored 24h and 72h after start of the exposure period.
Number of animals:
3 rabbits
Details on study design:
Areas of intact and abraded (to penetrate stratum corneum only) skin were treated on each rabbit.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24h and 72h
Score:
0
Max. score:
0
Remarks on result:
other: No signs of irritation observed.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h and 72h
Score:
0
Max. score:
0
Remarks on result:
other: No signs of irritation observed.
Irritant / corrosive response data:
No evidence of irritation was observed.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Open-site application of 0.5g test substance produced no evidence of skin irritation in this study.
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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Report of a study using a standard test method and with full detail of individual animal results.
Qualifier:
according to guideline
Guideline:
other: US Federal Register 29 (1964), section191.12
GLP compliance:
no
Remarks:
Pre-GLP study
Species:
rabbit
Strain:
other: described as albino rabbits
Details on test animals or tissues and environmental conditions:
Further details not available.
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
the lesser of 100 mg or 0.1 ml compacted volume.
Duration of treatment / exposure:
Applied and then scored after 24, 48 and 72h.
Observation period (in vivo):
24, 48 and 72h post-treatment.
Number of animals or in vitro replicates:
6
Details on study design:
Test substance placed into a cup formed by gently pulling the lower eye lid, then eyelids held together for one second. One eye/animal treated, the other serving as control.
Corneal, conjunctival and iridial reactions scored after 24, 48 and 72h.
Irritation parameter:
cornea opacity score
Basis:
other: all 6 test animals
Time point:
other: 24, 48 and 72h
Score:
0
Max. score:
0
Remarks on result:
other: No reactions seen
Irritation parameter:
iris score
Basis:
other: all 6 test animals
Time point:
other: 24, 48 and 72h
Score:
0
Max. score:
0
Remarks on result:
other: No reactions seen
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24h
Score:
0.67
Max. score:
1
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48h
Score:
0.17
Max. score:
1
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72h
Score:
0
Max. score:
0
Reversibility:
other: full recovery by this observation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24h
Score:
0.17
Max. score:
1
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 48h and 72h
Score:
0
Max. score:
0
Reversibility:
other: full recovery by the 48h observation
Irritant / corrosive response data:
No corneal or iridial reactions were seen.
Transient conjunctival redness was seen in 4 test rabbits: mean score 24+48+72h across all 6 animals = 0.28, maximum score at any observation =1.
A single observation of chemosis was recorded (one animal, 24h only).
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In this study only minor and transient conjunctival reactions were seen, following instillation of test substance into rabbit eyes.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin irritation tests included evaluation of effects on abraded skin as well as intact skin: only 24h occluded application of an aqueous 50% solution produced evident skin reaction. Tests with an intact skin barrier found no local reaction.

No major or irreversible reactions followed instillation into rabbit eyes.

A complete absence of skin reaction after 24h occluded application of test substance (at concentrations up tp 20% on water) to human volunteer subjects was seen, leading to a conclusion that the substance was non-irritating to human skin.

Justification for selection of skin irritation / corrosion endpoint:

The available studies demonstrate an absence of irritant effect on rabbit skin.

Justification for selection of eye irritation endpoint:

In the key study, minor and transient conjunctival reactions (maximum score 1, fully recovered by 3 days post-treatment) were seen in 4/6 test animals.

Justification for classification or non-classification

The reported absence of local effect on rabbit skin and minor effect shortly after instillation into rabbit eyes lead to the conclusion that no classification in respect of irritant action is warranted (under either CLP Regulation criteria or the older DSD rules).