Registration Dossier
Registration Dossier
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EC number: 274-402-1 | CAS number: 70210-05-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment. not GLP compliant
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Guidelines of the United States Environmental Pr otection Agency (EPA), Paragraph 163.81-5 "Primary dermal irritaion study", Federal Register, Vol 43 No. 163, August 22, 1978.
- GLP compliance:
- no
Test material
- Reference substance name:
- Disodium 3-[[2,4-bis(2-methylphenoxy)phenyl]azo]-4-hydroxy-5-[[(p-tolyl)sulphonyl]amino]naphthalene-2,7-disulphonate
- EC Number:
- 274-402-1
- EC Name:
- Disodium 3-[[2,4-bis(2-methylphenoxy)phenyl]azo]-4-hydroxy-5-[[(p-tolyl)sulphonyl]amino]naphthalene-2,7-disulphonate
- Cas Number:
- 70210-05-8
- Molecular formula:
- C37H31N3O11S3.2Na
- IUPAC Name:
- sodium (E)-3-((2,4-bis(o-tolyloxy)phenyl)diazenyl)-4-hydroxy-5-(4-methylphenylsulfonamido)naphthalene-2,7-disulfonate
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Animals were housed individually in metal cages.The animal room was air conditionned: temperature 22±3° C, relative humidity 55+15%; 12 hours light/day, approximately15 air changes/h.Source: New Zealand White Rabbits, Kleintierfarm Madoerin AG, CH-4414 FuellinsdorfRabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland),and water were provided ad libitum.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml of test material
- Duration of treatment / exposure:
- 24 h treatment
- Observation period:
- 24h, 48h, 72h, 4 and 7 days
- Number of animals:
- 3 male / 3 female
- Details on study design:
- 24 hours before treatement the flanks of the rabbits were shaved with an electric clipper (approximately 6 sq.cm each) and immediately before treatment the shaven skin on one side was slightly scarified with the help of a "Schroepfschnaepper", Aesculap, Switzerland. Gauze patches soaked (or loaded) with 0.5 ml of the test material were applied to the prepared abraded and intact skin.The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape. The dressing s were removed after 24 hours.The skin reaction was assessed upon removal and during a subsequent observation period of 7 days on the basis of the following evaluation scheme.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 20,21, 22,23,24
- Time point:
- other: mean score of 24, 48, 72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: no skin reaction observed
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal: 19
- Time point:
- other: mean score of 24, 48, 72 h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal: 20,22,23,24
- Time point:
- other: mean score of 24, 48, 72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: no skin reaction observed
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal: 19
- Time point:
- other: mean score of 24, 28, 72 h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal: 21
- Time point:
- other: mean score of 24, 48, 72h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: intact skin
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- since no animals were observed an average of erythema and eschar or edema more than 2, the sample is classified as not irritant for skin.
- Executive summary:
The substance has been tested for skin irritation with 6 New Zealand white rabbits with an occlusive method. After 7 days of observation no rabbit shows signs of erythema or edema. The substance is classified as non-irritating to the skin
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