Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

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:
secondary source
Title:
INITIAL SUBMISSION: SUMMARY OF RESULTS OF ACUTE TOXICITY STUDIES (FINAL REPORT) WITH ATTACHMENTS AND COVER LETTER DATED 112291
Author:
NTRL report
Year:
1991
Bibliographic source:
OTS0534168, NTRL report, 1991

Materials and methods

Test guideline
Qualifier:
according to
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 Cocamidopropyl betaine when instilled into the eyes of albino rabbits
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
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 - Physical state : Solid
Specific details on test material used for the study:
- Name of test material : 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts- Common Name: Cocamidopropyl betaine (CAPB)- Molecular formula: C19H38N2O3- Molecular weight: 342.52 g/mol- Smiles notation: CCCCCCCCCCCC(=O)NCCCN{+}(C)(C)CC(=O)O{-}- Substance type: Organic - Physical state: Solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Details on test animalTEST 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 dosingENVIRONMENTAL CONDITIONS- Temperature (°C): 60-75 deg F- Humidity (%): 55+/-25%- Air changes (per hr): no data available- Photoperiod (hrs dark / hrs light): 112 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 designREMOVAL 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 minuteSCORING 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

Resultsopen allclose all
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
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 Cocamidopropyl betaine 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.