Dodecyl(2-hydroxy-3-sulphonatopropyl)dimethylammonium

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 May 1995 to 31 July 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dodecyl(2-hydroxy-3-sulphonatopropyl)dimethylammonium

EC Number:

236-164-7

EC Name:

Dodecyl(2-hydroxy-3-sulphonatopropyl)dimethylammonium

Cas Number:

13197-76-7

Molecular formula:

C17H37NO4S

IUPAC Name:

dodecyl(2-hydroxy-3-sulphonatopropyl)dimethylammonium

Test material form:

solid

Specific details on test material used for the study:

Betadet S-20
Lot number: 7244
Appearance: transparent viscous liquid
pH: 7.49
Stored: Room temperature, protected from light.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Three New Zealand White male rabbits were used.
Weight on receipt: 2.0-2.4 kg
Age on receipt: approximately 9-110 weeks
Source: B and K Universal G.J., S.L.
Housing: Individually in stainless steel cages with a grill floor
Acclimatisation period: at least seven days
Weight at administration of test substance: 2.2-2.6 kg
Temperature: 18-22 degrees C
Humidity: 50-85%
Photoperiod: 12 hour dark/light cycle
Diet: Standard rabbit diet UAR 112, supplied by PANLAB, S. L., ad libitum
Water: Supplied by Compañia de Aguas de Sabadell, ad libitum

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 mL of undiluted test susbtance.

Duration of treatment / exposure:

24 hours.

Observation period (in vivo):

21 days after treatment

Number of animals or in vitro replicates:

Three

Details on study design:

Following administration of the test substance, the eyelids were held closed for approximately 10 seconds. The behaviour of the animals was observed following instillation of the test substance. The animals were then returned to their cages.

The dree of eye irritation as evaluated for each rabbit at 1, 24, 48 and 72 hours after treatment. Additional observations were made on Days 7, 14 and 21 after treatment to check the reversibility of the reactions.

Observations were made after applying 2% aqueous sodium fluorescein to test the area and washing with physiological saline, with the exception of the 1 hour observations. Corneal alterations were made with the aid of a transilluminator with a cobalt blue filter.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 21 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

1.22

Max. score:

4

Reversibility:

fully reversible within: 14 days

Other effects:

Behaviour and physical conditions of the rabbits were normal throughout the study.

One hour after administration, Betadet S-20 induced grade 2 redness in the palpebral conjunctivae of all the animals, accompanied by injected vessels in the bulbar conjunctivae and lacrimation. Swelling with partial inversion of the lids (grade 2) and congestion and injection of the iris (grade 1) was noted in all animals.

Any other information on results incl. tables

Eye irritation scores

	60 minutes	24 hours	48 hours	72 hours	Mean (24-72 hours)	7 days	14 days	21 days
Cornea	0,1,1	1,1,1	1,1,1	1,1,1	1.00	1,1,0	0,1,0	0,1,-
Iris	1,1,1	1,1,1	1,1,1	1,1,1	1.00	0,0,0	0,0,0	0,0,-
Erythema	2,2,2	2,2,2	2,2,2	2,2,2	2.00	1,1,1	1,1,0	0,0,-
Chemosis	2,2,2	1,2,1	1,2,1	1,1,1	1.22	1,1,1	0,0,0	0,0,-

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

Findings were reversible, with the exception of Grade 1 corneal opacity in one rabbit at 21 days.

Executive summary:

An eye irritation study was conducted with Betadet S-20 according to OECD Test Guideline 405. The test material was applied to the eyes of 3 rabbits (0.1 mL) for 24 hours. The animals were observed for 21 days. The corneal opacity, iris lesions, redness and chemosis were assessed after 1, 24, 48 and 72 hours post-treatment. Observations were also made on Days 7, 14 and 21 to check for reversibility. Signs of irritation were observed in all rabbits. Corneal opacity (Grade 1) was observed in all rabbits and persisted in one rabbit at study termination at Day 21. Iridial inflammation (Grade 1) was observed in all rabbits and was reversible by Day 7. Conjunctival erythema (Grade 2) was observed in all animals and was reversible by Day 21.

Conjunctival chemosis (Grade 2) was observed in all animals and was reversible by Day 14. The substance meets the CLP criteria for classification as a Category 2 eye irritant based on the mean (24 -72 hour) scores for corneal opacity, iridial inflammation and conjunctival erythema. However based on the finding of corneal opacity persisting to study termination in one rabbit, classification in CLP Category 1 is triggered.