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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:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
data is from NTRL reports

Data source

Reference
Reference Type:
secondary source
Title:
REPORT OF THE INDUSTRIAL TOXICOLOGY SCREENING STUDIES IN RATS, MICE AND RABBITS
Author:
NTRL
Year:
1992
Bibliographic source:
NTRL report, 1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Draize method
Principles of method if other than guideline:
Primary ocular irritation test was performed according to Draize method in albino rabbits
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
2-[3-(1,3-dihydro-1,3,3-trimethyl-2H-indol-2-ylidene)prop-1-enyl]-1,3,3-trimethyl-3H-indolium acetate
EC Number:
265-479-2
EC Name:
2-[3-(1,3-dihydro-1,3,3-trimethyl-2H-indol-2-ylidene)prop-1-enyl]-1,3,3-trimethyl-3H-indolium acetate
Cas Number:
65122-08-9
Molecular formula:
C25H29N2.C2H3O2
IUPAC Name:
1,3,3-trimethyl-2-[3-(1,3,3-trimethyl-1,3-dihydro-2H-indol-2-ylidene)prop-1-en-1-yl]-3H-indolium acetate
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report):1,3,3-trimethyl-2-[3-(1,3,3-trimethyl-1,3-dihydro-2H-indol-2-ylidene)prop-1-en-1-yl]-3H-indolium acetate - Common Name: Basic Red 12 acetate- Molecular formula:C25H29N2C2H3O2- Molecular weight:416.562 g/mol- Substance type:Organic- Physical state:Solid

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS- Source: GAUKLER 6050 OFFENBACH/ maIN- Age at study initiation:no data- Weight at study initiation: rabbit 1- 3.68 kg, rabbit 2- 3.67 kg and rabbit 3- 2.97 kg- Fasting period before study:no data- Housing: stainless steel cages with GRADE GROUND FLAT 40 CM * 50 cm- Diet (e.g. ad libitum): STANDARDIET FOR RABBIT 4mm; FA. SSNIFF-VERSUCHSDIAETEN GmbH, ~ 770 SOEST (Approximately 130 G PER ANIMALS)- Water (e.g. ad libitum): approx 250ml per rabbit, water (monday - friday), tap water (saturday - sunday)- Acclimation period: no dataENVIRONMENTAL CONDITIONS- Temperature (°C): 20-26 deg C- Humidity (%):50- 80%- Air changes (per hr):no data- Photoperiod (hrs dark / hrs light): 12h/12 H (6.00 - 18.00 UHR/16.00 - 6.00 UHR)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.1 ml undiluted sample
Duration of treatment / exposure:
single exposure
Observation period (in vivo):
1,24,48,72 hours and 8 days after application
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: according to Draize method of scoring

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: 8 days
Score:
46
Reversibility:
not specified
Remarks on result:
probability of moderate irritation
Irritant / corrosive response data:
moderately to severely irritating to eyes.

Any other information on results incl. tables

Observation Table:

Rabbit

1

2

3

Rabbit number

0293

0292

0271

Weight in (kg)

3.68

3.67

2.96

Gender

NA

NA

NA

 

Time (hours)

Animal number

Cornea

Iris

Conjunctiva

Symptom

Mean

TR

 

FL

 

Rd

SW

SE

24

1

1

4

0**

0**

3

2

50

30

2

1

4

0**

0**

3

3

50

32

3

1

4

0**

0**

3

3

50

32

MW

 

1

4

0

0

3

3

 

31

48

1

2*

4*

0**

0**

4

3

52

54

2

2

4

0**

0**

4

3

50

54

3

2

4

0**

0**

3

3

50

52

MW

 

2

4

0

0

4

3

 

53

72

1

2

4

0**

0**

4

3

50/NA

54

2

2

4

0**

0**

4

3

50/NA

54

 

3

2

4

0**

0**

3

3

50/NA

52

MW

2

4

0

0

4

3

 

53

8 DAYS

1

4

2

0**

2

4

3

50/NA/E

58

 

2

4*

2*

0**

2*

4

3

50/NA/E

58

 

3

4*

2*

0**

2*

4

3

50/NA/E

58

 

MW

4

2

0

2

4

3

 

58

HIGH REMOVAL PROVISIONS (BASIC SEE SYMPTOM):

*-HAVE BEEN TAKEN TO AN OFFICIAL DATE 1 - 2 ANIMAL ACTIVITIES THE GOOD WORK IS NOT POSSIBLE. SO ROUNDED VALUES SHOULD BE OBSERVED

**- HAVE BEEN TAKEN TO AN OFFICIAL DATE 1 - 2 ANIMAL ACTIVITIES THE GOOD WORK IS NOT POSSIBLE. So ROUNDED VALUES SHOULD BE OBSERVED

Evaluation of symptoms:

50- NO VALUE OF THE TRAVELING POINTS

52 -REPORTS NOTES OBSERVED TO OVERHEAD LEVELS

E -Terminated

NA - NA

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Primary eye irritation study for test chemical was performed in albino Vienna White rabbits according to Draize method. The Mean score after 8 days was 46.Based on the score,test chemical was considered to be moderately to severely irritating to eyes.
Executive summary:

Primary eye irritation study for test chemical was performed in albino Vienna White rabbits according to Draize method.

0.1 ml undiluted test chemical was instilled into the eyes of 3 albino Vienna White rabbits. The rabbits were observed from1,24,48,72 hours till 8 days after application of test chemical. The ocular lesions observed were scored according to the method of Draize.The Mean score after 8 days was 46.

Based on the score, test chemical was considered to be moderately to severely irritating to eyes.