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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP OECD Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 2004/73/EG, B.4; OECD 404 (2002)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Controls:
not required
Amount / concentration applied:
0.5 ml material molten at 50°C
Duration of treatment / exposure:
4 h
Observation period:
7 days
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24h, 48h and 72h
Score:
1.8
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h and 72h
Score:
1.1
Max. score:
2
Reversibility:
fully reversible within: 7 days

Any other information on results incl. tables

Very slight to well-defined erythema was noted at all treated skin sites one hour after patch

removal. Well-defined erythema was noted at all treated skin sites at the 24 and 48-hour

observations with very slight to well-defined erythema at the 72-hour observation.

Very slight oedema was noted at all treated skin sites one hour after patch removal with very

slight to slight oedema at the 24 and 48-hour observations. Very slight oedema was noted at one

treated skin site at the 72-hour observation.

An area of haemorrhage in the centre of the treatment site, approximately 10 mm x 10 mm, and

caused by removal of adhered test material, was noted at one treated skin site at the 1 and 24-hour

observations. A hardened light brown-coloured scab was noted at this treated skin site at the 48

and 72-hour observations with light brown discolouration of the epidermis and loss of skin

elasticity also noted at this treated skin site at the 72-hour observation. Slight desquamation was

noted at this treated skin site at the 7-day observation.

Two treated skin sites appeared normal at the 7-day observation.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material produced a primary irritation index of 2.7 and was classified as a
MODERATE IRRITANT to rabbit skin according to the Draize classification scheme. No
corrosive effects were noted. Not classified according to CLP criteria.