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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

A study similar or equivalent to EU Method B.4 and OECD Guideline 404 (Acute Dermal Irritation / Corrosion) was carried out. A group of six albino rabbits was treated with the test item (occlusive with 4 h exposure). No skin irritation was noted in any of the six animals at any of the observations at 4, 24 and 48 h. A primary irritation index of 0.0 was obtained. The test article was therefore regarded as a non-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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study.
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
other: Albino
Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
4 hour exposure
Observation period:
4, 24 and 48 hours
Number of animals:
Total of six animals
Details on study design:
TEST SITE
- Area of exposure: 1.5 x 1.5 inch
- % coverage: 100
- Type of wrap if used: Areas of exposure were covered by ply gauze squares. The patches were secured to the area by thin bands of adhesive tape. The entire trunks of the animals were then wrapped in clear plastic trunk bands.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Following this initial reading, all test sites were washed with appropriate solvent to prevent further exposure.
- Time after start of exposure: 4h

SCORING SYSTEM: Draize, 1944
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 4, 24, 48
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 4, 24, 48
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 4, 24, 48
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 4, 24, 48
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A primary skin irritation and corrosivity study was performed in the albino rabbit on the test item. No skin irritation was noted in any of the six animals at any of the observations at 4, 24 and 48 h. A primary irritation index of 0.0 was obtained. The test article was therefore regarded as a non-irritant.
Executive summary:

A study similar or equivalent to EU Method B.4 and OECD Guideline 404 (Acute Dermal Irritation / Corrosion) was carried out. A group of six albino rabbits was treated with the test item (occlusive with 4 h exposure). No skin irritation was noted in any of the six animals at any of the observations at 4, 24 and 48 h. A primary irritation index of 0.0 was obtained. The test article was therefore regarded as a non-irritant.

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

Additional information

Justification for classification or non-classification

Based on results obtained in acute toxicity testing the substance is not classified and labeled according to Regulation 1272/2008/EEC (CLP) and Directive 67/548/EEC (DSD).