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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:
key study
Study period:
07. Jun. 2005 - 14. Jun. 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
480-680-7
EC Name:
-
Cas Number:
120128-90-7
Molecular formula:
Hill formula: C8H16N2O3 CAS formula: C8H16N2O3
IUPAC Name:
480-680-7

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Species: rabbit
Breed: New Zealand White, IVA: NZW
Breeder: Charles River, Extertal, Germany
Date of receipt: 2005-05-31
Sex: 1 male and 2 female
Number: a total of 3
Body weights: 1793.3 g, 1807.7 g, 1988.1 g
Age: - 10 weeks
Identification: dyemarks and cage numbers
Diet: Altromin International, Lage, Germany, 2023 - 1518
Water: Normal tap water from municipal sources Stadtische Werke Krefeld AG, Krefeld, Germany, was offered. The water is monthly examined for pollutants which might interfere with the study. The data are retained in the archive. The water was supplied to the animals ad libitum via drinking bottles with rubber stoppers and steel pipes.
Husbandry: The rabbits were housed single in steel cages with a plastic bottom mould and a habitat of 5445 square cm2 at the bottom and an overall height of 600 mm. A non-barrier system with air conditioning was used. The air conditioning had the fol/owing nominal values: Temperature: 20 ± 3°C, Humidity: 30 - 70 %. Climate control was run automatically. Temperature and humidity were measured continuously using a thermohygrometer from Lambrecht GmbH, Gottingen, Germany. The data were archived. There have been no deviations from nominal temperature and humidity values during the experiment.
Bedding material: Lignocel BK 10/20, Rettenmaier & Stihne GmbH & Co., Ellwangen-Holzmuhle, Germany.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 mL of test substance into the right eye of each animal.
Duration of treatment / exposure:
1 hour
Observation period (in vivo):
Examination of the treated eyes was carried out 1 hour and approximately 24, 48, 72 hours and 7 days after application of the test substance.
Number of animals or in vitro replicates:
3
Details on study design:
Before the experiment was started, the animals were clearly marked with dye and weighed. Food and drinking water was left for the animals ad libitum.
Body weight was recorded immediately before test substance application and at the final observation 7 days later. The evaluation of the existing animal and in vitro studies revealed that the test substance is not corrosive or severely irritant. However, due to animal welfare reasons an initial test using one animal was performed. The test substance was applied into the right eye by pulling the lower eyelid away from the
eyeball to form a cup into which 0.1 ml of the test material was sprinkled in. The eyelid was gently held together for one second and then released. The left eye remained untreated and served as a control. As no corrosive or strong irritating effect was observed within one hour after application further two animals were treated in the same way. Examinations of ocular reactions were facilitated without any device. After recording the observations at 24 hours, the eyes of a\l rabbits were further examined with the aid of fluorescein to look for damage of the cornea. One drop of a 0.5 % (w/v) Fluorescein solution in saline solution was poured into both eyes and washed off with saline solution 30 seconds later. Afterwards scoring was executed by use of an UV-light lamp.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: slight ocular reactions 1 h after application of the test substance
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48h
Irritation parameter:
conjunctivae score
Basis:
animal: #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48h
Irritation parameter:
chemosis score
Basis:
animal: #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible

Any other information on results incl. tables

Ocular Lesions:

Animal No. 504 LV

1h

24h

48h

72h

7d

Mean (24-72h)

1. Cornea opacity

A

0

0

0

0

0

0.00

  Cornea area

B

0

0

0

0

0

0.00

2 Iris

A

0

0

0

0

0

0.00

3 Conjunctivae redness

A

1

1

0

0

0

0.33

  Conjunctivae chemosis

B

1

1

0

0

0

0.33

  Conjunctivae discharge

C

1

0

0

0

0

0.00

 

Animal No. 505 RV

1h

24h

48h

72h

7d

Mean (24-72h)

1. Cornea opacity

A

0

0

0

0

0

0.00

  Cornea area

B

0

0

0

0

0

0.00

2 Iris

A

0

0

0

0

0

0.00

3 Conjunctivae redness

A

1

0

0

0

0

0.00

  Conjunctivae chemosis

B

2

0

0

0

0

0.00

  Conjunctivae discharge

C

1

0

0

0

0

0.00

 

Animal No. 507 LH

1h

24h

48h

72h

7d

Mean (24-72h)

1. Cornea opacity

A

0

0

0

0

0

0.00

  Cornea area

B

0

0

0

0

0

0.00

2 Iris

A

0

0

0

0

0

0.00

3 Conjunctivae redness

A

1

0

0

0

0

0.00

  Conjunctivae chemosis

B

1

0

0

0

0

0.00

  Conjunctivae discharge

C

1

0

0

0

0

0.00

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
Conclusions:
The test results indicate a no eye irritation potential of the test substance Formamidopropyldimethylbetain 50 %ig to eyes and mucous membranes. All 3 animals showed slight ocular reactions 1 h after application of the test substance. 48 hours after application all three animals were without any sign of ocular irritation. The mean grades of reactions at 24, 48 and 72 h reading correspond to values classified as not irritant by the Directive 67/548/EEC as well as GHS Regulation EC No 1272/2008.
Executive summary:

For labelling and classification purposes the test substance Formamidopropyldimethylbetain 50 %ig was tested regarding its irritation potential towards eyes and adjacent mucous membranes of experimental animals. The potential to cause damage to the conjunctivae, iris and cornea was assessed by single application of the test substance into the lower conjunctival sac of the eyes of two female and one male rabbit, strain New Zealand White, according to the OECD Guideline for the Testing of Chemicals 405 "Acute Eye Irritation/Corrosion". Due to animal welfare reasons an initial test using one animal was performed. 0.1 ml of the test substance was applied to the eye of one animal. As no corrosive or strong irritating effect was observed within one hour after application further two animals were treated in the same way. Ocular reactions were assessed 1, 24, 48, 72 hours and 7 days after application of the test substance. At 24 hours post application the eyes of all animals were further examined with fluorescein to look for cornea damage. Systemic toxic symptoms after application were not observed at any time during the study. Body weight development was positive and within normal ranges. All 3 animals showed slight ocular reaction (conjunctivae redness 1 score, conjunctivae chemosis 1 or 2 scores and conjunctivae discharge 1 score) 1 h after application of the test substance. In one animal a slight conjunctivae redness and chemosis was still observed 24 h after application. 24 hours later (48 h after application) all three animals were without any sign of ocular irritation. Cornea damage or iris irritation was not observed at any time during the study. The Primary Irritation Index for the test substance Formamidopropyldimethylbetain 50 %ig was calculated to be "8" from "110" total possible scores at 1 h post application. Under the conditions of this study the test substance Formamidopropyldimethylbetain 50 %ig was graded as non-irritating to eyes and mucous membranes according to the Primary Irritation Index.