Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study was carried out under at a certified GLP laboratory using the OECD Guidelines for the Testing of Chemicals No. 404 “Acute Dermal Irritation/Corrosion” (adopted 24 April 2002) and Commission Directive 92/69/EEC Method B4 Acute Toxicity (Skin Irritation)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Liquid
Details on test material:
Material from production 98% min pure

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
4 hrs
Observation period:
6 mins
Number of animals:
3

Results and discussion

In vivo

Results
Irritation parameter:
other: produced reactions indicative of dermal corrosion
Basis:
mean
Remarks:
All animals tested
Time point:
other: 4 Hrs
Reversibility:
not reversible
Remarks on result:
other: animals were killed for humane reasons
Irritant / corrosive response data:
Brown/grey/green coloured dermal necrosis (attributed a Draize score of 4 for injuries in depth),
was noted over the whole of the test site and extended 1 to 2 cm beyond the test site of all animals
six minutes after patch removal. Severe oedema extending 5 to 6 cm beyond the treatment site
and raised 1 cm above the treatment site and blanching surrounding the necrotic area, were also
noted at all treated skin sites.
Other effects:
Damage to the left eye of one animal was noted with obvious redness of the iris and conjunctival
membranes

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU