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Registration Dossier
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EC number: 440-850-3 | CAS number: 27311-52-0
Skin irritation / corrosion
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:
- 1 998
- Report date:
- 1998
- Reference Type:
- other: abstract
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
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.
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