1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

data is from safety assessment reports

Data source

Reference

Reference Type:

other: secondary source

Title:

To determine the eye irritation potential of test chemical

Author:

NTRL report

Year:

1991

Bibliographic source:

OTS0534168, NTRL report, 1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: FEDERAL HAZARDOUS SUBSTANCE ACT, 16 CFR 1500.42

Principles of method if other than guideline:

To determine the degree of irritation produced by test chemical when instilled into the eyes of albino rabbits

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts

EC Number:

263-058-8

EC Name:

1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts

Cas Number:

61789-40-0

Molecular formula:

C19H38N2O3

IUPAC Name:

1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts

Details on test material:

- Name of test material : 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts
- Molecular formula : C19H38N2O3
- Molecular weight : 342.52 g/mol
- Smiles notation : CCCCCCCCCCCC(=O)NCCCN{+}(C)(C)CC(=O)O{-}
- Substance type : Organic

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Details on test animal

TEST ANIMALS
- Source: Buckshire Corp, USA
- Housing: individually housed in stainless elevated cages with wire mesh flooring
- Diet (e.g. ad libitum): Wayne 15% rabbit ration, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: the rabbits were acclimated to the laboratory for at least 5 days prior to dosing

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 60-75 deg F
- Humidity (%): 55+/-25%
- Air changes (per hr): no data available
- Photoperiod (hrs dark / hrs light): 12 hour light /dark cycleIN

-LIFE DATES: From: To:

Test system

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 ml of 50.7% w/v dilution in tap water

Duration of treatment / exposure:

single exposure

Observation period (in vivo):

1,2,3,4 and 7 days following instillation of the test chemical

Duration of post- treatment incubation (in vitro):

no data available

Number of animals or in vitro replicates:

9

Details on study design:

Details on study design

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: the treated eyes of 3 rabbits were washed after 30 seconds with tepid tap water( approx 1000ml/min) for 1 minute

SCORING SYSTEM: The treated eyes were examined at 1,2,3,4 and 7 days post instillation of the test chemical. The readings of the eyes were made in accordance with Draize technique for scoring of ocular lesions.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

21 d

Score:

0.7

Max. score:

110

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Remarks:

un washed eyes

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

21 d

Score:

18.7

Max. score:

110

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Remarks:

washed eyes

Irritant / corrosive response data:

The test chemical appears to be irritating to eyes. Washing of the eyes doesnot appear to be beneficial in reduction of the degree of irritation or the duration of irritation as seen in the unwashed eyes.

Any other information on results incl. tables

Average ocular irritation scores

Condition of eyes	Duration of exposure
	1 hour	1 day	2 day	3 day	4 day	7 day	14 days	21 day
Unwashed	16.0	18.8	18.3	14.5	12.2	5.0	2.3	0.7
Washed after 30 seconds	14.0	16.7	31.3	27.3	27.0	34.3	18.7	14.7

 

Fluorscein dye examination

Unwashed eyes

Observation period	Rabbit number
	1	2	3	4	5	6
Pre dosing	-	-	-	-	-	-
1 day	+	+	+	+	+	+
2 day	+	+	+	+	+	+
3 day	+	+	+	+	+	+
4 day	+	+	+	+	+	+
7 day	+	+	+	+	-	+
14 day	+	-	-	-	-
21 day	+

 

Washed eyes

 

Observation period	Rabbit number
	7	8	9
Pre dosing	-	-	-
1 day	+	+	+
2 day	+	+	+
3 day	-	-	+
4 day	+	+	+
7 day	+	+	+
14 day	+	+	+
21 day		-	+

 Where

 - = no corneal staining

+ = corneal staining

 

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

The average eye irritation index for the unwashed and washed eyes after 21 days of observation were 0.7 and 14.7 respectively. The test chemical appears to be irritating to eyes. Washing of the eyes doesnot appear to be beneficial in reduction of the degree of irritation or the duration of irritation as seen in the unwashed eyes.

Executive summary:

A study was conducted to determine the degree of irritation produced by test chemical when instilled into the eyes of albino rabbits. 9 New Zealand White rabbits were used for the study. 0.1 ml of 50.7% w/v dilution in tap water was instilled into the eyes of 9 rabbits. The untreated eyes served as control. The eyes of 6 rabbits remained unwashed throughout the test, but eyes of the remaining 3 rabbitswere washed after 30 seconds with tepid tap water( approx 1000ml/min) for 1 minute.The treated eyes were examined at 1, 2, 3, 4 and 7 days following instillation of the test chemical. Any eyes exhibiting ocular irritation at 7 days were also examined at 14 days and again at 21 days if ocular irritation persisted at 14 days. The treated eyes were examined at 1,2,3,4 and 7 days post instillation of the test chemical. The readings of the eyes were made in accordance with Draize technique for scoring of ocular lesions. The average eye irritation index for the unwashed and washed eyes after 21 days of observation were 0.7 and 14.7 respectively. The test chemical appears to be irritating to eyes. Washing of the eyes doesnot appear to be beneficial in reduction of the degree of irritation or the duration of irritation as seen in the unwashed eyes.