Registration Dossier
Registration Dossier
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Reaction products of (E)-5-((4-amino-5-methoxy-2-methylphenyl)diazenyl)-3-((phenylsulfonyl)oxy)naphthalene-2,7-disulfonic acid condensate with cyanurchloride, then condensate with (E)-7-amino-4-hydroxy-3-((2-methoxy-5-sulfophenyl)diazenyl)naphthalene-2-sulfonic acid, finally condensate with aniline, potassium salts
EC number: 948-912-6 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Remarks:
- Test substance is one component of the target (UVCB) substance; it is one of the major components, ranging between 10 - 60 % w/w. Other components show slight differences in terms of position / type of functional groups.
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Source study has reliability 2. Details on the read across are available in section 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
- Principles of method if other than guideline:
- Patch-test technique described in the "Appraisal of the safety of chemicals in foods, drugs and cosmetics" of the US Association of Food and Drug Officials (AFDO), 1959.
Compared to the currently accepted OECD guideline 404: duration was 24 h instead of 4 h; no rinse was done; application was also on scarified skin; no 48 h observation was done. - GLP compliance:
- no
Test material
- Reference substance name:
- Similar Substance 01_DR89_1
- IUPAC Name:
- Similar Substance 01_DR89_1
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.5 to 2 kg
- Housing: singly, in V2A wire cages
- Diet: ad libitum
- Water: ad libitum
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Remarks:
- intact and scarified
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
- Number of animals:
- 3 male / 3 female rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 × 2.5 cm gauze patch
- Type of wrap if used: 5 × 5 cm plastic film
OBSERVATION TIME POINTS
24 and 72 h after application.
SCORING SYSTEM:
Erythema and eschar formation
0 no erythema
1 very slight erythema (barely perceptible)
2 well defined erythema
3 moderate to severe erythema
4 severe erythema (beet redness) to slight eschar formation (injuries in depth)
Edema Formation
0 no edema
1 very slight edema (barely perceptible)
2 slight edema (edges of area well defined by definite raising
3 moderate edema (raised approximately 1 mm)
4 severe edema (raised more than 1 mm and extending beyond area of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
No signs of irritation were noted on both intact and scarified skin.
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritant according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Not irritant to skin of rabbits.
- Executive summary:
Method
Skin irritation potential of test substance was assessed by application of 0.5 g under gauze patches to both intact and scarified skin of 6 rabbits. Gauze patches were removed 24 h after application; skin reaction was scored 24 h (upon removal) and 72 h after application.
Results
No signs of skin irritation in terms of oedema and erythema were noted.
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