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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye 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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
To assess the eye irritation potential of Basic Red 12 in rabbits
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Solid crystalline powder
Details on test material:
- Name of test material: 2-[3-(1,3-dihydro-1,3,3-trimethyl-2H-indol-2-ylidene)prop-1-enyl]-1,3,3-trimethyl-3H-indolium chloride / Basic Red 12 / C.I. 48070
- IUPAC name: 1,3,3-trimethyl-2-[(1E)-3-[(2E)-1,3,3-trimethyl-2,3-dihydro-1H-indol-2-ylidene]prop-1-en-1-yl]-3H-indol-1-ium chloride
- Molecular formula: C25H29ClN2
- Molecular weight: 392.971 g/mole
- Smiles : c12c(C(C)(C)C(\N1C)=C/C=C/C=1C(c3ccccc3[N+]1C)(C)C)cccc2.[ClH-]
- Inchl: 1S/C25H29N2.ClH/c1-24(2)18-12-7-9-14-20(18)26(5)22(24)16-11-17-23-25(3,4)19-13-8-10-15-21(19)27(23)6;/h7-17H,1-6H3;1H/q+1;/p-1
- Substance type: Organic
- Physical state: Solid crystalline powder (Violet)
Specific details on test material used for the study:
- IUPAC name: 1,3,3-trimethyl-2-[(1E)-3-[(2E)-1,3,3-trimethyl-2,3-dihydro-1H-indol-2-ylidene]prop-1-en-1-yl]-3H-indol-1-ium chloride
- Molecular formula: C25H29N2.Cl
- Molecular weight: 392.971 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: >98%
- Impurities (identity and concentrations): <2% (The purified test samples contained water and such inert ingredients as sodium chloride, sodium sulphate. etc.)

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
no data available

Test system

Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
no data available
Observation period (in vivo):
no data available
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
no data available
Details on study design:
Scoring system: + = irritant; - = not irritating

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: no data available
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
signs of irritation observed

Any other information on results incl. tables

List of colorants to be classified as toxic

C.I Generic Name

CAS Number

CAS NAME

Active ingredient* in test sample

(%)

Irritation**

 

Symbol

R phrase

S phrase

Skin

[rabbits]

Eye

[rabbits]

C.I Basic Red 12

C.I 48070

6320-14-5

3H-Indolium,2-[3-(1,3-dihydro-1,3,3-

trimethyl-2H-indol-2-ylidine)-1-propenyl]-

1,3,3-trimethyl-,chloride

>98

-

+

T

25, 41

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:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Signs of irritation were observed when Basic red 12 was instilled to rabbit eyes, it can be considered to be irritating to eyes.
Executive summary:

The ocular irritation potential of Basic Red 12 was assessed in rabbits according to OECD 405 Guidelines.

Basic Red 12 was instilled into the eyes of rabbits and observed for signs of irritation (dose, duration, observation period not mentioned). The overall reactions were categorized -= not irritating and + = irritating.

Signs of irritation were observed when Basic red 12 was instilled to rabbit eyes, it can be considered to be irritating to eyes.