Betaines, coco alkyldimethyl(3-sulfopropyl)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1982-11-24 - 1982-12-13 (experimental phase)

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted May 12, 1981

Deviations:

no

GLP compliance:

yes

Remarks:

FDA principles

Test material

Test material information

Constituent 1

Reference substance name:

Betaines, coco alkyldimethyl(3-sulfopropyl)

EC Number:

269-225-1

EC Name:

Betaines, coco alkyldimethyl(3-sulfopropyl)

Cas Number:

68201-55-8

Molecular formula:

C7H17NO3S·[CH2]6-16

IUPAC Name:

[3-(dodecyldimethylazaniumyl)propyl]trioxo-λ⁶-sulfanuide

Test material form:

liquid

Remarks:

clear

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, 4414 Fuellinsdorf, Switzerland
- Age at study initiation: approx. 12 weeks
- Weight at study initiation: 2.3 - 3.0 kg
- Housing: Caged individually in stainless steel cages with automatic drinking water supply and cleaning system (Dipl. Ing. W. Ehret GmbH, Versuchstiertechnik, 7830 Emmendingen, Germany)
- Diet (e.g. ad libitum): Pelleted standard Kliba 23/341/1 rabbit maintenance diet (Klingentalmuehle AG, 4303 Kaiseraugst, Switzerland) defined for acceptable contaminant level, ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2°C
- Humidity (%): 55±10%
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1982-11-24 To: 1982-12-13

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:

single application, no wash-out

Observation period (in vivo):

14 days

Number of animals or in vitro replicates:

3 animals (2 males, 1 female)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

SCORING SYSTEM: Draize JH, 1959

TOOL USED TO ASSESS SCORE: none stated

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Remarks:

Primary Eye Irritation Index

Basis:

mean

Time point:

24/48/72 h

Score:

25.3

Remarks on result:

probability of mild irritation

Remarks:

slight irritation

Irritant / corrosive response data:

The test item showed a slight irritation when applied on the rabbit eye mucosa. No discoloration of the cornea and conjunctivae was observed (score: zero) in the rabbits during the entire test period which could be related to effects of the test material. No corrosion effect was observed at each of the measuring intervals.

Other effects:

- Other adverse systemic effects: No acute toxicological signs were observed in the animals during the test period, no mortalities occurred.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Remarks:

EU

Conclusions:

The study was conducted under GLP according to OECD TG 405 on the registered substance itself. The method is to be considered scientifically reasonable with no deficiencies. Hence, the results can be considered as sufficiently reliable to assess the irritating properties of the test item.
According to Regulation (EC) 1272/2008 table 3.3.2, a substance must be classified as Irritating to eyes (Category 2), if, when applied to the eye of an animal, a substance produces:
— at least in 2 of 3 tested animals, a positive response of:
— corneal opacity ≥ 1 and/or
— iritis ≥ 1, and/or
— conjunctival redness ≥ 2 and/or
— conjunctival oedema (chemosis) ≥ 2
— calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days
In the present test, Cornea opacity is 1.66 in 2 of 3 animals, the other criteria are not met. However, this result is sufficient to classify the substance as Eye Irr. Cat. 2
No corrosion effect was observed at each of the measuring intervals.

Executive summary:

The eye irritating / corrosive properties of the test item were evaluated in a OECD 405 GLP study in three New Zealand White rabbits after single instillation of 100µl into the conjunctival sac. The test item showed a slight irritation when applied to the rabbit eye mucosa. No discoloration of the cornea and conjunctivae which could be related to effects of the test item was observed. The primary skin irritation Index was found to be 25.3 (unrinsed eyes). No corrosion effect was observed at each of the measuring intervals. Cornea opacity is 1.66 at 24, 48 and 72 hours after installation in 2 of 3 animals, so the substance should be classified as Eye Irr. Cat. 2 according to Regulation (EC) 1272/2008.