Fatty acids, C12-18 (even numbered)-methyl esters, sulfonated, sodium salts

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 - 15 January, 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

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)

Version / remarks:

Commission Directive 92/69/EEC

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C12-18, α-sulfo, 1-Me esters, sodium salts

EC Number:

288-224-7

EC Name:

Fatty acids, C12-18, α-sulfo, 1-Me esters, sodium salts

Cas Number:

85681-86-3

Molecular formula:

C13H25NaO5S - C19H37NaO5S

IUPAC Name:

Fatty acids, C12-18, α-sulfo, 1-Me esters, sodium salts

Constituent 2

Reference substance name:

Fatty acids, C12-18, α-sulfo, disodium salts

EC Number:

286-085-7

EC Name:

Fatty acids, C12-18, α-sulfo, disodium salts

Cas Number:

85186-99-8

Molecular formula:

C12H22Na2O5S - C18H34Na2O5S

IUPAC Name:

Fatty acids, C12-18,α-sulfo, disodium salts

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 weeks old
- Weight at study initiation: 2.96 kg
- Housing: Individually housed in a suspended metal cage.
- Diet: ad libitum - STANRAB SQC Rabbit Diet, Special Diet Services Ltd., Witham, Essex, UK
- Water: ad libitum - mains water
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-21
- Humidity (%): 51-58
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

VEHICLE
- Amount(s) applied (volume or weight with unit): Not applicable

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

One animal was used.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not washed
- Time after start of exposure:Not applicable

SCORING SYSTEM: Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment using the Draize system.

TOOL USED TO ASSESS SCORE: Light source from a standard ophthalmoscope

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

not reversible

Remarks:

based on 72 h score

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

not reversible

Remarks:

based on 72h score

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not reversible

Remarks:

based on 72 h score

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Reversibility:

not reversible

Remarks:

based on 72 h score

Irritant / corrosive response data:

Refer to Table 1 below for scores at each time point.

Other effects:

Vocalisation was noted approximately 15 seconds after dosing.
Residual test material was noted around the treated eye one hour after treatment.
A dulling of the normal lustre of the corneal surface was noted in the treated eye one hour after treatment. Areas of diffuse corneal opacity were noted in teh treated eye at the 24 and 48-hour observations with areas of translucent corneal opacity at the 72-hour observation.
Iridial inflammation was noted in the treated eye one hour after treatment and at subsequent observations.
Sever conjuctival irritation was noted in the treated eye one hour after treatment with moderate conjunctival irritation at the 24 and 48-hour observations and severe conjunctival irritation at the 72-hour observations. Haemorrhage of the nictitating membrane was noted in the treated eye at the 24, 48 and 72-hour observations. Pale appearance of the nictitating membrane and blood stained discharge were noted in the treated eye at the 72-hour observation.
The animal was killed for humane reasons immediately after the 72-hour observation. No further animals were treated.

Any other information on results incl. tables

Table 1: Scores at each time point

Rabbit Number and Sex (Bodyweight Kg)	IPR 4 Vo                                          29 Male (2.96)
Time after treatment	1 hour	24 hours	48 hours	72 hours^K
CORNEA
E = Degree of Opacity	d	1	1	2^+
F = Area of Opacity	4	4	4	4
Score (E x F) x 5	0	20	20	40
IRIS
D	1	1^+	1^+	1^+
Score (D x 5)	5	5	5	5
CONJUNCTIVAE
A = Redness	2	2^H	2^H	2^HBsP
B = Chemosis	3	2^+	2^+	3^+
C = Discharge	3^Re	3	3	3
Score (A + B + C) x 2	16	14	14	16
Total Score	21	39	39	61

Key:

IPR = initial pain reaction; D = dulling of the normal lustre of the corneal surface; Vo = vocalisation of approx. 15 seconds after dosing; P = pale appearance of the nictitating membrane; K = animal killed immediately after observation; H = Haemorrhage of the nictitating membrane; Re = residual test material around the treated eye; Bs = blood-stained discharge; + = positive criterion

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

Mean scores following grading at 24, 48 and 72 hours for corneal opacity (1.3), iritis (1), conjunctival redness (2) and chemosis (2.3) do not meet CLP criteria for irreversible effects on the eye (category 1). However, the animal exhibited distinct ocular effects and was killed for humane reasons immediately after the 72-hour observation. There are consequently grounds for concluding that the effects seen would not have been reversible and that classification for category 1 eye effects is warranted.

Executive summary:

In a study performed according to OECD TG 405 and EU Method B.5, a single application of the test material was made to the non-irrigated eye of one rabbit. Areas of translucent corneal opacity, iridial inflammation and severe conjunctival irritation were produced. Other ocular effects noted were a dulling of the normal lustre of the corneal surface, haemorrhage and pale appearance of the nictitating membrane and blood stained discharge. The animal was killed for humane reasons immediately after the 72-hour observation. No further animals were treated. Mean scores following grading at 24, 48 and 72 hours for corneal opacity (1.3), iritis (1), conjunctival redness (2) and chemosis (2.3) do not meet CLP criteria for irreversible effects on the eye (category 1). However, the animal exhibited distinct ocular effects that required premature termination. There are consequently grounds for concluding that the effects seen would not have been reversible and that classification for category 1 eye effects is warranted.