Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant study conducted according to OECD Guidelines, with no or minor deviations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
according 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: pale yellow liquid
Details on test material:
Batch number: 256181
Purity : 96.7%
Expiry date : October 10, 1997

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
1 male
2 females

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL (per animal) applied
Duration of treatment / exposure:
4 hours
Observation period:
1h, 24h, 48h, 72 hours and 7 days, 14 days, 21 days
Number of animals:
1 male
2 females

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 7
Time point:
other: mean value 24, 48 and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: male
Irritation parameter:
erythema score
Basis:
animal: 8
Time point:
other: mean value 24, 48 and 72 hours
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: female
Irritation parameter:
erythema score
Basis:
animal: 9
Time point:
other: mean value 24, 48 and 72 hours
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: female
Irritation parameter:
edema score
Basis:
animal: 7
Time point:
other: mean value 24, 48 and 72 hours
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: male
Irritation parameter:
edema score
Basis:
animal: 8
Time point:
other: mean value 24, 48 and 72 hours
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: female
Irritation parameter:
edema score
Basis:
animal: 9
Time point:
other: mean value 24, 48 and 72 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: female

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: EU GHS
Conclusions:
According to this test the DECENAL-4-TRANS is slightly irritant. However based on the scores, it is not sufficient to be classified irritant accroding the EU GHS.