Registration Dossier

Administrative data

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: Assessed after consultation with the relevant Authority. Data migrated from NONS files provided by Authority contain insufficient information.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Report Date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes
Remarks:
PHARMACO-LSR LTD. EYE, SUFFOLK IP23 7PX

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): BTN/A
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: test sites were moistened with distilled water before treatment
Vehicle:
other: none
Controls:
not specified
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48, 72 hours
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48, 72 hours
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48, 72 hours
Score:
0
Irritation parameter:
erythema score
Basis:
animal: #1, 2, 3 (highest value)
Time point:
other: no data
Score:
0
Reversibility:
other: no effects
Remarks on result:
other: Max. duration: d; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: overall at 24, 48, 72 hours
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: overall at 24, 48, 72 hours
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: overall at 24, 48, 72 hours
Score:
0
Irritation parameter:
edema score
Basis:
animal: #1, 2, 3 (highest value)
Time point:
other: no data
Score:
0
Reversibility:
other: no effects
Remarks on result:
other: Max. duration: d; Max. value at end of observation period: 0 (related to all animals)

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
DSD: not classified
CLP: not classified