Fatty acids, C12-18 and C18-unsatd., 2-sulfoethyl esters, sodium salts

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986-09-11 to 1986-09-25

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study not conducted according to GLP; however the study was conducted in a manner equivalent to relevant OECD guideline (405). The study contains a quality assurance statement and was conducted in accordance to the methodology proposed under the United States Federal Hazardous Substances Labelling Act (Federal Register, 1964, 29 13009).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

Post-treatment observations were not performed at 14 and 21 days.

GLP compliance:

no

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

Test report states that sample 758.05 is 47.5% sodium cocoyl isethionate in a soap bar. The substance was described as a waxy, white solid.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hazelton Research Products, Inc.
- Age at study initiation: no data
- Weight at study initiation: >1.5kg
- Housing: Elevated wire mesh cages
- Diet (e.g. ad libitum): measured amount of Purina High Fiber Rabbit Chow (6oz/day) was offered to all rabbits rather than ad libitum feed.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: >/= 7 days


ENVIRONMENTAL CONDITIONS

- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
- Temperature: 22-27 Degrees C
- Humidity: 56-79%


IN-LIFE DATES: From: 1986-09-11 To: 1986-09-25

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100mg
- Concentration (if solution): not applicable


VEHICLE
Not applicable

Duration of treatment / exposure:

Eyes were not flushed of test material, therefore the duration of exposure was 7 days

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
not applicable - test substance was not flushed out of eyes


SCORING SYSTEM:
Draize technique

TOOL USED TO ASSESS SCORE: sodium fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 24 hours

Score:

<= 34.2

Max. score:

34.2

Reversibility:

not specified

Remarks on result:

other: See table 1 below

Results 2

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 48 hours

Score:

<= 31

Max. score:

31

Reversibility:

not specified

Remarks on result:

other: See table 1 below

Results 3

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 72 hours

Score:

<= 28.8

Max. score:

28.8

Reversibility:

not specified

Remarks on result:

other: See table 1 below

Results 4

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 4 days

Score:

<= 28

Max. score:

28

Reversibility:

not specified

Remarks on result:

other: See table 1 below

Results 5

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 7 days

Score:

<= 20.3

Max. score:

20.3

Reversibility:

not specified

Remarks on result:

other: See table 1 below

Irritant / corrosive response data:

See table 1 below

Other effects:

None

Any other information on results incl. tables

Table 1: Average Eye Irritation Scores

Observation Period	Cornea		Iris	Conjunctivae
	Opacity	Area		Redness	Chemosis	Discharge
Day 1	1.0	3.3	0.8	2.2	2.5	2.0
Day 2	1.0	2.8	0.8	2.5	2.7	1.2
Day 3	1.2	2.2	0.8	2.2	2.8	1.5
Day 4	1.3	1.8	0.7	2.0	2.3	1.3
Day 7	0.8	1.2	0.7	1.5	1.7	1.2

Table 2: Animal Body Weights

Animal Number	Sex	Vocalisation following dosing	Animal body weights (g)
			Initiation	Day 7	Day 14
4736	M	N	2626	2860	2932
4737	M	N	2736	2862	2839
4738	M	N	2676	2636	2806
4776	F	N	2164	2432	2565
4740	F	N	2705	2886	3018
4741	F	N	2473	2668	2813

 

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Based on the average scores for redness and chemosis, the substance showed irritating
properties under the conditions of this study.

Executive summary:

In this study, where 6 rabbits received a single application of 100 mg of the substance (47.5% pure), iris lesions and redness and chemosis of the conjunctivae were seen. Blanching of the conjunctivae was seen in all animals at Day 1, in two animals at Day 2, in three animals at Day 3, and one animal at Days 4 and 7. Corneal epithelial peeling was observed in all animals on Days 1 and 2, in five animals at Days 3 and 4, and in four animals at Day 7. Other signs observed in some animals included necrosis, pannus, and corneal neovascularisation. The average Draize score is determined to be 2.0, however for redness and chemosis of the conjunctivae the scores are higher. There was no pain response in any of the animals, no clinical signs were observed and all animals had healthy body weight gain.