Registration Dossier
Registration Dossier
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EC number: 947-403-6 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from peer reviewed journals
Data source
Reference
- Reference Type:
- publication
- Title:
- List of colorants to be classified as toxic
- Author:
- R Anliker, G Diirig, D Steinle and E J Moriconi
- Year:
- 1 988
- Bibliographic source:
- Journal of the Society of Dyers and Colourists, Volume 104 May/June 1988,223-225
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- To assess the skin irritation potential of the test chemical in rabbits
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2-[2-[4-(diethylamino)phenyl]vinyl]-1,3,3-trimethyl-3H-indolium chloride
- EC Number:
- 228-799-3
- EC Name:
- 2-[2-[4-(diethylamino)phenyl]vinyl]-1,3,3-trimethyl-3H-indolium chloride
- Cas Number:
- 6359-45-1
- Molecular formula:
- C23H29N2Cl
- IUPAC Name:
- 2-[(E)-2-[4-(diethylamino)phenyl]ethenyl]-1,3,3-trimethyl-3H-indol-1-ium chloride
- Test material form:
- solid
- Details on test material:
- Name of the test chemical:2-[(E)-2-[4-(diethylamino)phenyl]ethenyl]-1,3,3-trimethyl-3H-indol-1-ium chlorideCommon name: C.I Basic Violet 16Molecular Formula: C23H29N2.ClMolecular Weight: 368.949 g/molSubstance Type: OrganicPhysical State: SolidPurity: 94%Impurities: The purified test samples contained water and such inert ingredients as sodium chloride, sodium sulphate etc.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- no data available
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- no data available
- Duration of treatment / exposure:
- no data available
- Observation period:
- no data available
- Number of animals:
- no data available
- Details on study design:
- Scoring system: + = irritant; - = not irritating
Results and discussion
In vitro
- Other effects / acceptance of results:
- no data available
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: no data available
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- no signs of irritation observed
Any other information on results incl. tables
List of colorants to be classified as toxic
Active ingredient* in test sample (%) | Irritation**
| Symbol | R phrase | S phrase | |
Skin [rabbits] | Eye [rabbits] | ||||
94 | - | + | T | 25, 36 | 22 , 26, 44 |
*- The purified test samples contained water and such inert ingredients as sodium chloride, sodium sulphate etc.
** - Based on test procedures according to OECD guidelines for testing of chemicals: 'Acute oral toxicity' (No. 401), 'Acute dermal irritation/corrosion' (No 404) and 'Acute eye irritation/corrosion' (No. 405)
Risk (R) Phrases
23 -toxic by inhalation
24 - toxic in contact with skin
25-toxic if swallowed
33 -danger of cumulative effects
36-irritating to eyes
41-risk of serious damage to eyes
Safety(S)phrases
22-do not breathe dust
26-incase of contact with eyes, rinse immediately with plenty of water and seek medical advice
28 - after contact with skin, wash immediately with plenty of soap and water
36 -wear suitable protective clothing
37-wear suitable gloves
44 - if you feel unwell seek medical advice (show the label if possible)
+ = irritant;- =non-irritant
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- Since no reactions were observed when the test chemical was applied to rabbit skin, it can be considered to be not irritating to skin.
- Executive summary:
The dermal irritation potential of the test chemical was assessed in rabbits according to OECD 404 Guidelines.
The test chemical was applied to the skin of rabbits and observed for signs of irritation (dose, duration, observation period not mentioned). The overall reactions were categorized -= not irritating and + = irritating.
Since no reactions were observed when the test chemical was applied to rabbit skin, it can be considered to be not irritating to skin.
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