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Toxicological information

Skin irritation / corrosion

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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: According to the OECD Guideline and GLP

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998
Reference Type:
other: abstract
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Ro 1525 corresponds to Colipa A 155
Ro 1525
Batch No.: Ro-Rn 6567-083.
SAT 980375

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
undiluted, moistened
Duration of treatment / exposure:
24 hour(s)
Observation period:
1,24,48 and 72 hours
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable, no irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable, no irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable, no irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable, no irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable, no irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable, no irritation

Any other information on results incl. tables

3.1. General signs nf toxicity

There was no general toxic effect of "Ro 1525" noted.

3.2. Skin examination

(Table 1)

The scoring scheme is given in Table 2.

All areas treated with the test substance were normal before application.

The control areas were normal at any obsemation time.

A grey staining of the skin at the application site was seen in all animals 1 and 24 h after patch

removal, which is not considered to be a toxic effect.

3.2.1. Examinations 1 hour after patch removal

Erythemdeschar: Very slight erythema (score "1" each) in animals No. 21 and No. 22.

Oedema: Scores of " 0 ,i. e. normal, in all animals.

3.2.2. Examinations 24,48 and 72 hours after patch removal

Erythemdeschar and Oedema: No lesions were observed at any examination term for each

animal.

3.2.3. Additional examinations

As only Scores of "0, i.e. normal, were noted at examination terms 24,48 and 72 h after patch

removal, no additional examinations were performed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Classification: not irritating
Executive summary:

The following mean Scores were calculated for the individual examinations 24,48 and

72 h after patch removal:

Erythemaleschar: "0.0 in all animals.

Oedema: "0.0 in all animals.

These means indicate "no adverse skin reaction" of "Ro 1525" in this study.

Aim of the study

The aim of this study was to investigate possible reversible or irreversible irritancy andlor

corrosion by the test substance following a single application to the intact skin of rabbits.

Methods

Methods and investigations were performed in conformance with the OECD Guideline 404 .

Administration of the test substance

Approximately 0.5 g "Ro 1525" were applied to the intact skin (covered with a patch) of each

of 3 rabbits.

The duration of the exposure was 4 hours.

Investigations

Body weight: at the start and at the termination of the test.

0 General signs of toxicity: once daily.

0 Skin examination: 1,24,48 and 72 h after patch removal.

Results

General signs of toxicity

No general toxic effects of the test substance were observed.

Skin examination

A grey staining of the skin at the application site was seen in all animals 1 and 24 h after patch

removal.

Erythemaleschar and Oedema: Except for very slight erythema, observed in 213 animals

1 h after patch removal, no lesions were noted at the other examination terms.