Registration Dossier

Administrative data

Description of key information

Coco fatty acids 2-sulfoethyl ester, sodium salt, is not classified as irritating to skin in rabbits, causing only slight skin irritation in the key study. There are three eye irritation studies, the key study and main supporting study indicate that Coco fatty acids 2-sulfoethyl ester, sodium salt is moderately irritating to eyes and requires classification under EU CLP(GHS).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1983-04-26 to 1983-06-10
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Not conducted according to GLP or OECD gudeline but equivalent to OECD guideline 404, with modified scoring scheme. Test substance (Fenopon AC798) idetfied in study report as Sodium Lauryl isethionate.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Scoring system for skin irritation is based on a scale of 0-7 not 1-5 but is equivalent to Draise.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: 9-12 weeks
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum):no data
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data


IN-LIFE DATES: no data
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.2g test solid (83% active) applied to a moistened patch
- Concentration (if solution): not applicable


VEHICLE
not applicable, test material applied as a solid
Duration of treatment / exposure:
4 hours
Observation period:
4, 24, 48 & 72 hours after treatment
Number of animals:
8 per group
Details on study design:
TEST SITE
- Area of exposure: dorsal surface
- % coverage: no data
- Type of wrap if used: cotton gauze under zinc oxide plaster under thin, flexible polythene wrap


REMOVAL OF TEST SUBSTANCE
- Washing (if done): none (treatment sites wiped clean of excess test material upon removal of patches)
- Time after start of exposure: 4 hours


SCORING SYSTEM: 8-point scale ranging from "a" (very slight) to "h" (severe)

Insert table of overall test scoring system (p. 13)
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 4 h
Score:
>= 1
Max. score:
1
Reversibility:
no data
Remarks on result:
other: Mean score for 8 animals.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 4 h
Score:
>= 1
Max. score:
1
Reversibility:
no data
Remarks on result:
other: Mean score for 8 animals.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h
Score:
>= 1.3
Max. score:
2
Reversibility:
no data
Remarks on result:
other: Mean score for 8 animals.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h
Score:
>= 1
Max. score:
1
Reversibility:
no data
Remarks on result:
other: Mean score for 8 animals
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 h
Score:
>= 0.9
Max. score:
1
Reversibility:
no data
Remarks on result:
other: Mean score for 8 animals.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 h
Score:
>= 0.9
Max. score:
1
Reversibility:
no data
Remarks on result:
other: Mean score for 8 animals.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 h
Score:
>= 0.6
Max. score:
1
Reversibility:
fully reversible within: 3 out of 8 animals
Remarks on result:
other: Mean score for 8 animals.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 h
Score:
>= 0.4
Max. score:
1
Reversibility:
fully reversible within: 5 out of 8 animals
Remarks on result:
other: Mean score for 8 animals.

Table 1: Summary of Skin Irritation Results

Rabbit No.

4 hours

24 hours

48 hours

72 hours

Er*

Oe**

Er

Oe

Er

Oe

Er

Oe

351

1

1

2

1

1

1

1

1

356

1

1

1

1

1

1

0

0

359

1

1

1

1

1

1

0

0

385

1

1

1

1

1

1

1

0

398

1

1

1

1

1

1

1

0

400

1

1

1

1

0

0

0

0

401

1

1

1

1

1

1

1

1

404

1

1

2

1

1

1

1

1

Mean

1

1

1.3

1

0.9

0.9

0.6

0.4

*Erythema

**Oedema

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Sodium Cocoyl Isethionate (83% ai) is slightly irritant to rabbit skin when tested as supplied.
Executive summary:

The skin irritation potential of Sodium Cocoyl Isethionate (83%ai) was studied in an in vivo rabbit skin irritation study.

Fenopon AC78 (83% ai) is slightly irritant to rabbit skin when tested as supplied.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was only carried out for 7 days and the effects are not fuly reversibel within that time period but the a decrease in severty was seen over a period of 7 days. Therefore the assumption is made that the effests are likely to be fully reversible within 21-days and the study may be used for C&L.
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Remarks:
audited inhouse
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harald Schriever, Kaninchenfarm D -2740 Bremervorde, Neuendamm 88
- Age at study initiation: no data
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: Single caging in battery of cages size: 40 cm high, 45 cm wide, 50 cm long with paper roll disposal system.
- Diet (e.g. ad libitum): ad libitum
Producer: Ssniff Spezialfutter GmbH, 4770 Soest/ Westfalen, Name: Ssniff Mu Z (Alleindiat fur Zuchtkaninchen) Type: pellets, 1.0 - 1.5 cm large, 0.5 cm diameter
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 2
- Humidity (%): 50-85
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: no data
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
0.1 g of the testmaterial was placed into the conjunctival sac of the left eye while the right eye served as I control. On animal 4- 6 the treated eye was carefully washed out 4 sec p.a. with lukewarm water.
Observation period (in vivo):
Prior to treatment, 24 hours p. a. and if necessary 7 days p. a., the eyes were examined for potential eyelesions by means of 1 % Fluorescin. The eyes were scored at 1, 2, 8 hours and 1, 2, 3, 4, 5, 6 and 7 days after treatment.
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): On animal 4- 6 the treated eye was carefully washed out
- Time after start of exposure: 4 sec p.a. with lukewarm water


SCORING SYSTEM: DRAIZE
Scoring system eye irritation

Cornea: degree of density (area most dense taken for reading)
0 No ulceration or opacity
1 Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible
2 Easily discernible translucent areas, details of iris slightly obscured
3 Nacrous areas, no details of iris visible, size of pupil barely discernible
4 Opaque cornea, iris not discernible through the opacity

Area of Cornea Involved
1 One quarter (or less) but not zero
2 Greater than one quarter but less than half
3 Greater than half but less than three quarters
4 Greater than three quarters, up to whole area

Iris
0 Normal
1 Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or combination of any thereof) Iris still reaction to light (sluggish reaction is positive)
a x 5, total maximum = 10 No reaction to light .Hemorrhage. Gross destruction (any or all of these) (2)

Conjunctivae
Redness (refers to palpebral and bulbar conjunctivae cornea and iris)

0 Blood vessels normal
1 Some blood vessels definitely hyperaemic
(injected)
2 Diffuse, crimson colour, individual vessels not easily discernible
3 Diffuse, beefy red

Chemosis (lids and/or nictitating membranes)
0 No swelling 0
1 Any swelling above normal (includes nictitating membranes)
2 Obvious swelling with partial eversion of lids
3 Swelling with lids about half-closed
4 Swelling with lids more than half-closed

Discharge
0 No discharge
1 Any amount different from normal (does not include small amounts observed in inner canthus of normal animals)
2 Discharge with moistening of the lids and hairs just adjacent to lids
3 Discharge with moistening of the lids and hairs a considerable area around the eye
Score (a + b + c ) x 2 Total maximum = 20

TOOL USED TO ASSESS SCORE: no data
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
animals 1-3
Time point:
other: 24-48-72 hours
Score:
1.2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: The study was terminated after 7 days.
Irritant / corrosive response data:
After treatment in none of the animals effects on the cornea were observed. One hour after treatment effects on the Iris were observed in all animals. One animal from the group where the eye was not washed out did not react to light up to 5 days after treatment. In two animals from this group effects on the Iris were not fully reversible, in one animal the effests disappeared after 5 days. In the group where the eyes were washed out after 4 seconds effects were not fully reversible in one animals and in the two other animals effects were gone on day 2 or 4. Conjunctivae were affected in all animals with 4 as the highest score in one animal for chemosis. In the first group on day 2 effects started to decrease but were only fully reversible within 7 days in one animal. In the second group the same effecst were observed but only less severe with a higest score of 3. In two animals effects were fully reversible on day 4 or 5, in the third animals effects were not fully reversible after 7 days.

Without removal of the test substance

Rabbit No and sex

Region of the eye

Hours after instillation

Average 24-48-72hours

24

48

72

1

Cornea

Degree of opacity

0

0

0

0

Area of opacity

0

0

0

0

Iris

2

2

2

2

Conjunctivae

Redness

3

3

2

2.7

Chemosis

3

3

2

2.7

Discharge

2

2

1

1.7

2

Cornea

Degree of opacity

0

0

0

0

Area of opacity

0

0

0

0

Iris

1

1

1

1

Conjunctivae

Redness

3

1

1

1.7

Chemosis

3

2

1

2

Discharge

2

1

1

1.7

3

Cornea

Degree of opacity

0

0

0

0

Area of opacity

0

0

0

0

Iris

1

1

1

1

Conjunctivae

Redness

3

1

1

1.7

Chemosis

4

2

2

2.7

Discharge

2

2

1

1.7

Removal of the test substance after 4 seconds

Rabbit No and sex

Region of the eye

Hours after instillation

Average 24-48-72hours

24

48

72

4

Cornea

Degree of opacity

0

0

0

0

Area of opacity

0

0

0

0

Iris

1

1

1

1

Conjunctivae

Redness

3

3

3

3

Chemosis

3

3

2

2.7

Discharge

2

2

2

2

5

Cornea

Degree of opacity

0

0

0

0

Area of opacity

0

0

0

0

Iris

1

1

1

1

Conjunctivae

Redness

3

1

1

1.3

Chemosis

3

2

1

2

Discharge

2

0

0

0.7

6

Cornea

Degree of opacity

0

0

0

0

Area of opacity

0

0

0

0

Iris

1

0

0

0.3

Conjunctivae

Redness

3

2

2

2.3

Chemosis

3

2

2

2.3

Discharge

2

0

0

0.7

Interpretation of results:
Category 2A (irritating to eyes) based on GHS criteria
Remarks:
Migrated information
Conclusions:
The test substance causes a score of ≥ 1 for iris and a ≥ 2 score for chemosis. The effects are not fully reversible within 7 days but the a decrease in severty was seen over a period of 7 days. Therefore the assumption is made that the effests are likely to be fully reversible within 21-days and the substance is calssified in catergory 2A (irritating to eyes).
Executive summary:

An eye irritation study was carried out acoording to OECD405 and inhouse quality assurance was in place.

0.1g of the test substance (white powder) was instilled in the eyes of 6 rabbits. In 3 rabbits the eyes were washed after 4 seconds. Prior to treatment, 24 hours post application and if necessary 7 days post application, the eyes were examined for potential eyelesions by means of 1 % Fluorescin.

The eyes were scored at 1, 2, 8 hours and 1, 2, 3, 4, 5, 6 and 7 days after treatment.

After treatment in none of the animals effects on the cornea were observed. One hour after treatment effects on the Iris were observed in all animals. One animal from the group with unwashed eyse did not react to light up to 5 days after treatment. In two animals from this group effects on the Iris were not fully reversible, in one animal the effests disappeared after 5 days.

In the group where the eyes were washed out after 4 seconds effects were not fully reversible in one animals and in the two other animals effects were gone on day 2 or 4. Conjunctivae were affected in all animals with 4 as the highest score in one animal for chemosis.

In the first group on day 2 effects started to decrease but were only fully reversible within 7 days in one animal.

In the second group the same effecst were observed but only less severe with a higest score of 3. In two animals effects were fully reversible on day 4 or 5, in the third animals effects were not fully reversible after 7 days.

The test substance causes a score of ≥ 1 for iris and a ≥ 2 score for chemosis. The effects are not fully reversible within 7 days but the a decrease in severty was seen over a period of 7 days. Therefore the assumption is made that the effests are likely to be fully reversible within 21-days and the substance is classified in catergory 2A (irritating to eyes).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Coco fatty acids 2-sulfoethyl ester, sodium salt is only slightly irritating to the skin of rabbits when tested undiluted. When tested in rabbit eyes it produced eye irritation but the effects seen where considered being reversible within 21 days.

We have no test data for respiratory irritation. Inhalation is not an expected route of exposure but based on its eye irritation properties Coco fatty acids 2-sulfoethyl ester, sodium salt might cause some irritation in the respiratory tract if inhaled. However in the absence of any specific information it is not considered that a classification is required under EU CLP (GHS) for respiratory irritation.

Justification for selection of skin irritation / corrosion endpoint:

There are two skin irritation studies in rabbits, the key study is the Unilever skin irritation study which has Klimisch reliability 2, it was not conducted according to GLP or a specific OECD guideline, but it was equivalent to OECD 404 and conducted in a high quality testing facility.  This study showed only slight skin irritation for the Coco fatty acids 2-sulfoethyl ester, sodium salt with a typical 83% active sample, this does not result in a classification under EU CLP(GHS).   The second study Sterner, 1985 is Klimisch validity 3 as the Coco fatty acids 2-sulfoethyl ester, sodium salt was tested at only 2% active, so the results are not suitable for classification and labeling purposes.  The study was carried out before GLP.  No skin irritation was observed.

Justification for selection of eye irritation endpoint:

There are three eye irritation studies in rabbits; the key study is Sterner and Chibanguza, 1988.  This is a Klimisch 2 as the study was terminated after 7 days when there was not complete recovered of the irritant effects seen in the eyes.  However the effects were significantly reduced to the extent that it is concluded that they would have been full reversible in 21 days.  The scores seen for eye irritation would result in an EU CLP(GHS) classification of category 2 or in a global GHS classification of category 2A for eye irritation. There tow supporting studies HPV Data Eye irritation which is also Klimisch 2 but only used a 47.5% solution of Coco fatty acids 2-sulfoethyl ester, sodium salt, this also showed eye irritation bu a classification verdict was not recorded.  The third weight of evidence study was also Klimisch 2, it was not GLP or to an OECD guideline but was similar to OECD 405.  The main limitation as that the test substance was a 15% solution of Coco fatty acids 2-sulfoethyl ester, sodium salt in a gel cleaner formulation, the study concluded that the formulation was an eye irritant to US consumer product safety commission regulation 16 CFR 1500.3(c).

Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: moderately irritating

Justification for classification or non-classification

Coco fatty acids 2-sulfoethyl ester, sodium salt when tested on rabbit skin was slightly irritant, and the scores did not meet the criteria for classification as a skin irritant under EU CLP(GHS) or global GHS. There are two acceptable quality studies on eye irritation in rabbits, the key study is on the undiluted product and resulted in eye irritation scores of>1 for the iris and>2 for chemosis which corresponds to a classification by EU CLP(GHS) criteria of category 2 of eye irritation ( category 2A for global GHS). In the absence of any specific information it is not considered that a classification is

required under EU CLP (GHS) for irritation of the respiratory tract.