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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Skin irritation

Key study:

In a study performed according to 16 C.F.R. 1500.41 of the U.S. Federal Hazardous Substances Act Regulations test item has been determined as not classified in relation to skin irritation according to GHS criteria.

Eye irritation

Key study:

In a study performed according to 16 C.F.R. 1500.42 of the U.S. Federal Hazardous Substances Act Regulations the test material is not an ocular irritant.

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:
09 February 1981 to 12 February 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
other: 16 C.F.R. 1500.41 of the U.S. Federal Hazardous Substances Act Regulations
Deviations:
no
GLP compliance:
not specified
Specific details on test material used for the study:
- Date received: 28 January 1981
Species:
rabbit
Strain:
not specified
Remarks:
albino
Details on test animals or test system and environmental conditions:
The animals were housed and maintained in compliance with the Animal Welfare Act (Pub. L- 94- 279) 9 CFR Part 3.
Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
24 hours
Observation period:
Immediately following treatment and 48 hours later.
Number of animals:
Six
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: observation period of 48 hours post treatment
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: observation period of 48 hours post treatment
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: observation period of 48 hours post treatment
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Interpretation of results:
GHS criteria not met
Conclusions:
The test material is not a skin irritant.
Executive summary:

In a study performed according to 16 C.F.R. 1500.41 of the U.S. Federal Hazardous Substances Act Regulations test item has been determined as not classified in relation to skin irritation according to GHS criteria.

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

Additional information

Justification for classification or non-classification