Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1996-10-22 to 1996-10-01
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study OECD 404, OECD 1981, updated guideline, adopted 1992. Deviation: The purity of the test substance is not mentioned

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Molecular formula (if other than submission substance): C2F5(C2F4)nJ; (n= 2-5)
- Molecular weight (if other than submission substance): 530g/mol
- Physical state: violet fluid
- Analytical purity: n/a
- Impurities (identity and concentrations): n/a
- Composition of test material, percentage of components: n/a
- Lot/batch No.: P.96029
- Expiration date of the lot/batch: 1998-07-16
- Storage condition of test material: darkness at room temperature in a fume cupboard

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 ml per patch
Duration of treatment / exposure:
4 hours
Observation period:
30-60 min, 24, 48 and 72 hours
Number of animals:
3

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
#1, #2, #3
Time point:
other: 24h, 48h and 72h after patch removal
Score:
0
Max. score:
0
Remarks on result:
other: none

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study the test substance is not irritating to skin