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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 registration substance is not irritating to skin and not irritating to eye.

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:
2002-2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Observation period:
3 days
Number of animals:
3
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Interpretation of results:
GHS criteria not met
Conclusions:
The registration substance was investigated for its skin irritation property according to the OECD Guideline 404. The registration substance is not irritating to skin.
Executive summary:

The registration substance was investigated for its skin irritation property according to the OECD Guideline 404. 0.5g of the registration substance suspended in water was dermally applied to rabbits using semi-occlusive patch for 4 hours. No indication of irritation was found upon 24/48/72 reading time. The registration substance is not irritating to 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:
2002-2003
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
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
once
Observation period (in vivo):
3 days
Number of animals or in vitro replicates:
3
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.11
Max. score:
1
Reversibility:
fully reversible within: 48h
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.11
Max. score:
1
Reversibility:
fully reversible within: 48h
Remarks on result:
no indication of irritation
Interpretation of results:
GHS criteria not met
Conclusions:
The eye irritation property of the registration substance was investigated according to the OECD Guideline 405. The registration substance is not eye irritating.
Executive summary:

The eye irritation property of the registration substance was investigated according to the OECD Guideline 405. Three rabbits were used. 100 mg of the registration substance was applied to one eye of each rabbit. No effects were seen in two rabbits. Only one rabbit exhibited slight effects (conjunctivae store of one and chemosis score of one) at 24h reading time and these effects were fully reversible by the 48h reading time. The registration substance is not eye irritating.

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

Additional information

Justification for classification or non-classification

The registration substance was investigated for its skin and eye irritation according to the OECD Guideline 404 and 405 respectively. No indication of skin irritation and no indication of eye irritation was found. No classification is justified.