Reaction mass of 3H-Indolium, 2-[[2-(4-methoxyphenyl)-2-methylhydrazinylidene]methyl]-1,3,3-trimethyl- and acetate

Eye irritation

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

Test material information

Constituent 1

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.