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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report which meets basic scientific principles, only a 10% aqueous substance preparation was tested.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975
Reference Type:
other: OECD SIDS
Title:
Unnamed
Year:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Patch-test according to FDA guidelines
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: yellow crystals

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5-2.0 kg
- Housing: individually
- Diet: Mischfutter ERKA 8300 der Futtermittelwerke Robert Koch oHG/ Hamm, ad libitum
- Water: tap water, ad libitum

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: intact and abraded skin
Vehicle:
other: sesame oil
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 10% in sesame oil
Duration of treatment / exposure:
24 h
Observation period:
up to 72 h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: surgical gauze, kept in place using adhesive tape, was covered with a 6-8 cm wide PVC film after which the bodies of the animals were wrapped in elastic binding

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 1 - 4
Time point:
other: 24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: intact and abraded skin
Irritation parameter:
erythema score
Basis:
animal: 5, 6
Time point:
other: 24 h
Score:
0
Max. score:
4
Remarks on result:
other: intact and abraded skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48, 72 h
Score:
0
Max. score:
4
Remarks on result:
other: intact and abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Remarks on result:
other: intact and abraded skin
Irritant / corrosive response data:
Weak erythema (score 1) was observed in 4 out of 6 animals at both intact and abraded skin sites. It was fully resolved at 48 hours observation.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information