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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
EPA 560/6-83-001
GLP compliance:
yes
Species:
rabbit
Strain:
not specified
Type of coverage:
occlusive
Vehicle:
other: neat
Controls:
not specified
Amount / concentration applied:
600 mg
Duration of treatment / exposure:
4 h
Number of animals:
6 (3 male, 3 female)
Irritation parameter:
erythema score
Basis:
mean
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: d; Max. value at end of observation period: 0
Irritation parameter:
edema score
Basis:
mean
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: d; Max. value at end of observation period: 0
Other effects:
No irritant response was observed.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance was found to be non-irritating to rabbit skin.
Executive summary:

The study was performed according to OECD guideline no. 404 and EU method B.4. 0.5 ml test item was applied to one intact skin site for 4 hrs on each 6 rabbits (3M,3F). No signs of irritancy (oedema or erythema) were seen in any of the animals. Scores were all 0. The study ended after 72 hours. In conclusion, the substance was found to be non-irritating to rabbit 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:
1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
EPA 50/6-82-001
GLP compliance:
yes
Species:
rabbit
Strain:
not specified
Vehicle:
other: neat
Amount / concentration applied:
120 mg
Number of animals or in vitro replicates:
6
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 0.67
Max. score:
0.16
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 0
Max. score:
0
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 0
Max. score:
0
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 0
Max. score:
0
Remarks on result:
other: Max. duration: h; Max. value at end of observation period: 0
Irritant / corrosive response data:
Reversibility of any observed effect: changes fully reversible after 3 days
Other effects:
Severity of conjuntival erythema decreased with time: no reaction seen at 72 hours
Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The substance was found to be non-irritating to rabbit eyes.
Executive summary:

The study was performed according to OECD guideline no. 405 and EU method B.5. 0.1 ml of test article was instilled into the right eye (conjunctival sac) of each of 6 rabbits. Observations were recorded at 1, 24, 48 and 72 hrs after treatment. Scoring was conducted according to the Draize method. No iritis or corneal changes were seen in any of the animals. The substance does not have to be classified as an irritant on the basis of the test results.

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

Additional information

Justification for selection of skin irritation / corrosion endpoint:
Available study

Justification for selection of eye irritation endpoint:
Available study

Justification for classification or non-classification

The substance was found to be non-irritating to rabbit skin. The substance was found to be non-irritating to rabbit eyes.