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Toxicological information

Skin irritation / corrosion

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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:
1988
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

Constituent 1
Chemical structure
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.

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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