Registration Dossier
Registration Dossier
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EC number: 265-529-3 | CAS number: 65151-26-0
Skin irritation / corrosion
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:
- guideline study without detailed documentation
- Remarks:
- limited documentation regarding composition of test material
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- according to the Swiss Ordinance relating to GLP [RS 813.016.5]
Test material
- Reference substance name:
- Disodium 7-[(4-amino-3-methoxyphenyl)azo]naphthalene-1,3-disulphonate
- EC Number:
- 265-529-3
- EC Name:
- Disodium 7-[(4-amino-3-methoxyphenyl)azo]naphthalene-1,3-disulphonate
- Cas Number:
- 65151-26-0
- Molecular formula:
- C17H15N3O7S2.2Na
- IUPAC Name:
- disodium 7-[(4-amino-3-methoxyphenyl)diazenyl]naphthalene-1,3-disulfonate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g test item/per animal - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours after administration
- Number of animals:
- 3 (2 males, 1 female)
- Details on study design:
- SCORING SYSTEM: Draize J H (1959) "Dermal Toxicity" in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Assoc. of Food and Drug Officials of the US, Austin, Texas p47
- Method of calculation: mean of the 24, 48, 72 reading, separately for each rabbit and each type of skin reaction.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal:
- Remarks:
- # 71, 72, 74 each
- Time point:
- other: mean of the 24-48-72 h reading
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable since no signs of irritation (edema) at any time
- Irritation parameter:
- erythema score
- Basis:
- animal:
- Remarks:
- # 71, 72, 74 each
- Time point:
- other: mean of the 24-48-72 h reading
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable since no signs of irritation (erythema) at any time
- Remarks on result:
- other: dark orange coloured staining produced by the test item
- Irritant / corrosive response data:
- no signs of irritation were observed at any time
- Other effects:
- The test item caused a marked dark orange staining at the test site of all animals
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- not irritating
- Conclusions:
- The test substance has not to be classified according regulation (EU) 1272/2008, Annex I, 3.2.
- Executive summary:
The test material was subject to an acute dermal irritation/corrosion test in 3 New Zealand White rabbits (2 males, 1 female) according to OECD TG 404. A single 4-hour semi-occluded application (0.5 g) of the test material was administered to the intact skin of three rabbits. Skin reactions were recorded 1, 24, 48 and 72 hours after administration. No skin reactions occurred during the observation period.
The mean score for oedema and erythema grades was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal separately. The mean score for oedema and erythema was 0 for all three animals. The application of the test item to the skin resulted in marked dark orange staining produced by the color of test item of the treated skin in all animals at the 1- hour reading and persisted in all animals up to the end of the observation period. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed.
Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008.
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