Reaction products of fatty acid chlorides, C8-12 (even numbered) with glycine and sodium hydroxide

Endpoint summary

Description of key information

Hostapon SLG is not irritating to skin based on the read-across to Hostapon SG:

Hostapon SG (25% Sodium N-Cocoyl Glycinate) is not skin irritating based on the results obtained in in-vivo study

Hostapon SG (70% Sodium N-cocoyl Glycinate) is not skin irritating based on the results obtained in in-vitro study.

Hostapon SLG (25 % Sodium N-Lauroyl Glycinate) is eye irritating and Hostapon SLG (70% Sodium N-Lauryl Glycinate) is eye damaging based on the read-across to Hostapon SG:

Hostapon SG (25% Sodium N-cocoyl glycinate) is eye irritating based on the result obtained in in-vivo study.

Hostapon SG (70% Sodium N-cocoyl glycinate) is eye damaging based on the result obtained in in-vitro study.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012-02-28 to 2012-03-05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other: EU Method B.46 (Skin Irritation)

Qualifier:

according to guideline

Guideline:

other: OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method

GLP compliance:

yes (incl. QA statement)

Species:

other: EpiSkin reconstructed human epidermis model

Strain:

not specified

Details on test animals or test system and environmental conditions:

organotypic reconstructed three-dimensional model of the human epidermis

Type of coverage:

other: direct application

Preparation of test site:

not specified

Vehicle:

not specified

Controls:

other: negative control: 10µl PBS; positive control: 10µl 5% SDS

Amount / concentration applied:

10 mg + 5 µL aqua dest.

Duration of treatment / exposure:

15 minutes

Observation period:

42 +/- 1 h

Number of animals:

three replicate tissues per dose group

Details on study design:

3 replicate tissues are dosed with the test item, the negative control (PBS) and the positive control (5% SDS), respectively. After 15 minutes treatment period at room temperature the test item and the controls are rinsed off with PBS and the tissues are post-incubated for 42 +/- 1 h. Then the tissues are stained via MTT for 3 hours. The isopropanol extracts are measured photometrically at 550 nm.

Irritation / corrosion parameter:

other: other: mean relative tissue viability

Value:

> 50

Remarks on result:

other:

Remarks:

Basis: other: mean tissue viability of the negative control tissues. Time point: 15 min treatment 42 h post-incubation. Remarks: non-irritant EU CLP and UN GHS: No Category. (migrated information)

Irritation / corrosion parameter:

other: other: mean relative tissue viability

Value:

<= 50

Remarks on result:

other:

Remarks:

Basis: other: mean tissue viability of the negative control tissues. Time point: 15 min treatment 42 h post-incubation. Remarks: irritant EU CLP and UN GHS Category 2. (migrated information)

 

Name	Negative Control			Positive Control			Test Item
Tissue	1	2	3	1	2	3	1	2	3
absolute OD550	1.325	1.338	1.225	0.144	0.135	0.138	1.471	1.394	1.475
	1.260	1.311	1.196	0.143	0.131	0.144	1.408	1.386	1.418
blank-corrected OD550	1.282	1.295	1.182	0.102	0.092	0.095	1.428	1.351	1.432
	1.217	1.268	1.153	0.100	0.089	0.101	1.365	1.343	1.375
mean OD550of the duplicates (blank-corrected)	1.250	1.282	1.168	0.101	0.090	0.098	1.397	1.347	1.404
total mean OD550of 3 replicate tissues (blank-corrected)	1.233^*			0.096			1.383
SD OD550	0.06			0.01			0.04
relative tissue viabilities [%]	101.4	103.9	94.7	8.2	7.3	8.0	113.3	109.3	113.8
mean tissue viability [%]	100.0			7.8^**			112.1
SD tissue viability [%]^***	4.8			0.4			2.5
CV [% viability]	4.8			5.6			2.2

^*          Corrected mean OD₅₅₀of the negative control corresponds to 100% absolute tissue viability.

^**      mean relative tissue viability of the three positive control tissues is£ 40%

^***     the standard deviation (SD) obtained from the three concurrently tested tissues is < 18%

Interpretation of results:

GHS criteria not met

Conclusions:

Hostapon SG (70% N-cocoyl glycinate) is not irritating to skin

Executive summary:

The skin irritant potential of the Hostapon SG (70% N-cocoyl glycinate) was investigated using the EPISKIN-Standard Model (EPISKIN-SM^TM). The test compound was applied topically to the EPISKIN-SM tissue for 15 minutes followed by a 42 hour post incubation period and immediate determination of cytotoxic effects via MTT reduction assay. No significant effect was found. Hostapon SG is not skin irritating.

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Netherlands BV
- Age at study initiation: 14 weeks (males, females)
- Weight at study initiation: 2.2 kg (male); 2.5 kg (females)
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: yes

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 10 - 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hour cycle dark / light

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL / animal
- Concentration (if solution): undiluted

Duration of treatment / exposure:

4 hour

Observation period:

14 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: approx. 10 cm x 10 cm
- % coverage: 100
- Type of wrap if used: surgical gauze patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours

SCORING SYSTEM: Irritation scoring according to Council Regulation (EC) No 440/2008

Irritation parameter:

erythema score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

1.67

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

1.33

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

1.67

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

1.11

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

1.33

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Other effects:

Scaling noted

Interpretation of results:

GHS criteria not met

Conclusions:

Hostapon SG (25% N-cocoyl glycinate) is not irritating to skin according to the GHS classification criteria.

Executive summary:

Hostapon SG was investigated for its skin irritation property according to the Guideline OECD 404. The test item was applied by topical semi-occlusive application of 0.5 mL to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours, as well as 7, 10 and 14 days after removal of the dressing. The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. The mean erythema/eschar score of the three animals was 1.33, 1.67 and 2.00, respectively and the mean oedema score was 1.00, 1.33 and 1.00, respectively. The application of Hostapon SG to the skin resulted in mild to moderate signs of irritation. These included erythema, oedema, scaling and dry / inelastic skin. In the male, these effects were reversible and were no longer evident 14 days after treatment. Both females were still observed with scaling of the skin on day 14 post treatment, the end of the observation period. The test item caused no staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed. Based on the results, the registered substance is not regarded a skin irritant according to GHS classification criteria.

Reference 3

Endpoint:

skin irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Justification is provided in Chapter 13.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Netherlands BV
- Age at study initiation: 14 weeks (males, females)
- Weight at study initiation: 2.2 kg (male); 2.5 kg (females)
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: yes

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 10 - 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hour cycle dark / light

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL / animal
- Concentration (if solution): undiluted

Duration of treatment / exposure:

4 hour

Observation period:

14 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: approx. 10 cm x 10 cm
- % coverage: 100
- Type of wrap if used: surgical gauze patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours

SCORING SYSTEM: Irritation scoring according to Council Regulation (EC) No 440/2008

Irritation parameter:

erythema score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

1.67

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

1.33

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

1.67

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

1.11

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

1.33

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Other effects:

Scaling noted

Interpretation of results:

GHS criteria not met

Conclusions:

Not irritating

Executive summary:

The skin irritation of the registration substance Hostapon SLG was evaluated based on the read-across approach using the data for Hostapon SG.

Hostapon SG (25% Sodium N-Cocoyl Glycinate) was investigated for its skin irritation property by topical application to rabbits for 4hours. Mild to moderate reversible irritating effects were noted, meeting the criteria of "not irritating" according to GHS. Hostapon SG (70% Sodium N-Cocoyl Glycinate) was investigated using reconstructed human skin model (EPISKIN). No significant irritating effect was found.

Likewise, no concern can be derived for the registration substance Hostapon SLG.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012-02-21 to 2012-05-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)

GLP compliance:

yes (incl. QA statement)

Remarks:

Bayerisches Landesamt für Gesundheit und dLebensmittelsicherheit, München, Germany)

Vehicle:

physiological saline

Amount / concentration applied:

The test item was diluted with physiological saline 0.9% NaCl to gain a 20% concentration.

Duration of treatment / exposure:

750 microL of the test item preparation or the control substance was introduced into the anterior chamber (closed-chamber method).
After 4 hours ± 5 minutes incubation at 32 +/- 1 °C either the test substance or the control substance was removed.

Details on study design:

Test System

Preparation of the Corneas:
The assay uses isolated corneas obtained as a by-product from an abattoir from freshly slaughtered animals
(from Attenberger Fleisch GmbH & Co. KG).
On the test day, fresh eyes were collected from the slautherhouse and were transported in HBSS containing Pen/Strep on ice to the laboratories.
Immediately after arrival of the eyes, cornea preparation was initiated.
The eyes were carefully examined for defects and any defective eyes were discarded.
The tissue surrounding the eyeball was carefully pulled away and the cornea was excised leaving a 2 to 3 mm rim of sclera.
The isolated corneas were stored in a petri dish containing HBSS. Before the corneas were mounted in corneal holders
(MC2, Clermont, France) with the endothelial side against the O-ring of the posterior chamber, they had been visually
examined for defects and any defective cornea had been discarded. The anterior chamber was then positioned on top
of the cornea and tightened with screws. The chambers of the corneal holder were then filled with RPMI (without phenol red)
containing 1% FBS and 2 mM L-glutamine (complete RPMI). The posterior chamber was always filled first. The corneas were
incubated for one hour at 32 +/- 1 °C in a water bath.

Calibration of the Opacitometer:
The opacitometer had been switched on 15 min before the calibration procedure was started. Empty cornea holders were
placed into the opacitometer and the readout was adjusted to zero using the “BAL”-turning knob. For calibration the polyester
foil no. 1 was introduced into the test chamber and the readout was adjusted to 75 using the “CAL”-turning knob. To test the
linearity of the measurement, two additional calibration foils, polyester foil no. 2 and polyester foil no. 3, were measured.
For these, the opacitometer was supposed to display 150 and 225, respectively (± 3%). If this had not been the case,
the calibration procedure would have had to be repeated. The calibration procedure was performed before each test
and was documented in the raw data.

Treatment of the Corneas:
After the equilibration period, the medium was removed from both chambers and replaced with fresh Complete RPMI.
An initial opacity measurement was performed on each of the corneas using an opacitometer (MC2, Clermont, France).
Three corneas with opacity readings approximately equivalent to the median opacity of all corneas were selected as
negative-control corneas. The opacity of each cornea was read against an air-filled chamber and recorded. Corneas
that have an initial opacity reading above 7 units were not dosed. The medium was removed from the anterior chamber
and replaced with the test item or control.
750 microL of the test item preparation or the control substance was introduced into the anterior chamber (closed-chamber method).
After 4 hours ± 5 minutes incubation at 32 +/- 1 °C either the test substance or the control substance was removed
and the epithelium washed at least three times with MEM (containing phenol red). Once the medium was free of test substance,
the cornea was finally rinsed with complete RPMI (without phenol red). The anterior chamber was refilled with complete RPMI
and an opacity measurement was performed.
After the opacity measurement the medium was removed from both chambers of the holder. The posterior chamber was
refilled with fresh complete RPMI. 1 mL of a 5 mg/mL sodium fluorescein solution was added to the anterior chamber and
the corneas were incubated for 90 minutes at 32 +/- 1 °C. Then the medium from the posterior chamber was removed and
its optical density at 490 nm (OD490) was determined, using a spectrophotometer.

Test Groups:
3 corneas for the test item
3 corneas as negative controls treated with physiological saline 0.9% NaCl
3 corneas as positive control treated with imidazole 20% in physiological saline 0.9% NaCl
The BCOP assay is considered to be valid if the in vitro score obtained with the positive control falls within the two
standard deviations of the current historical mean.

Evaluation of Results:
The change in opacity for each cornea was calculated by subtracting the initial opacity reading from the final opacity reading.
These values were corrected by subtracting from each the average change in opacity observed for the negative-control corneas.
The mean opacity value for each treatment was calculated by averaging the corrected opacity values of each cornea for a given treatment.
The mean OD490 for the blank wells were calculated. The mean blank OD490 was subtracted from the OD490 of each well (corrected OD490).
Any dilutions that were made to bring the OD490 values into the linear range of the spectrophotometer (OD490 should be less than 1.500),
were taken into account by multiplying the OD490 value of the dilution by the dilution factor. The final-corrected OD490 of the test article
and the positive control were calculated by subtracting the average corrected OD490 of the negative control corneas from the corrected
OD490 value of each treated cornea:
Final-corrected OD490 = (OD490 – mean blank OD490) – average-corrected negative control OD490
The mean OD490 value of each treatment group was calculated by averaging the final corrected OD490 values of the treated corneas for
that treatment condition.
The following formula was used to determine the in vitro score:
In vitro score = mean opacity value + (15 x mean OD490 value)

Irritation parameter:

in vitro irritation score

Value:

242

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Table2:  Opacity

Cornea No.	Test Item	Initial Opacity	Final Opacity	Change of Opacity Value	Corrected Opacity Value
1	Negative	4	5	1
2	Control	4	4	0
3		4	5	1
MV		4.00	4.67	0.67
4	Positive	5	229	224	223.33
5	Control	5	168	163	162.33
6		4	216	212	211.33
MV		4.67	204.33	199.67	199.00
7	Test Item	3	187	184	183.33
8		3	283	280	279.33
9		3	172	169	168.33
MV		3.00	214.00	211.00	210.33

 

Table3:  Permeability

Cornea No.	Test Item	OD490	Corrected OD490 Value
1	Negative	0.020
2	Control	0.016
3		0.034
MV		0.023
4	Positive	2.114	2.091
5	Control	2.006	1.983
6		1.944	1.921
MV		2.021	1.998
7	Test Item	2.146	2.123
8		2.140	2.117
9		2.148	2.125
MV		2.145	2.121

 

Table4:  In VitroIrritation Score

Cornea No.	Test Item	Corrected Opacity Value	Corrected OD490 Value	IVIS
1	Negative	1.00	0.020
2	Control	0.00	0.016
3		1.00	0.034
MV		0.67	0.023	1.02
4	Positive	223.33	2.091
5	Control	162.33	1.983
6		211.33	1.921
MV		199.00	1.998	228.97
7	Test Item	183.33	2.123
8		279.33	2.117
9		168.33	2.125
MV		210.33	2.121	242.15

 

Interpretation of results:

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

Conclusions:

Hostapon SG (70% Sodium N-Cocoyl Clycinate) is eye damaging according to the results obtained in BCOP study.

Executive summary:

Hostapon SG (70% N-cocoyl glycinate) was investigated for its eye irritation property according to the Guideline OECD 437. The obtained IVIS of 242.15 is indicative that Hostapon SG is eye damaging.

Reference 2

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study according to GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan Netherlands BV
- Age at study initiation: 15 weeks (male), 16 weeks (females)
- Weight at study initiation: 2.4 kg (male), 2.5 - 2.6 kg (females)
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: yes

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 10 - 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hour dark / light cycle

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

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

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours

SCORING SYSTEM: numerical scoring system according Council Regulation (EC) 440/2008

TOOL USED TO ASSESS SCORE: fluorescein, diagnostic-lamp

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: no signs of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: no signs of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: no signs of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: no signs of irritation

Irritation parameter:

iris score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: no signs of irritation

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: no signs of irritation

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: no signs of irritation

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: no signs of irritation

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

1.77

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

1.67

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

1.67

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

1.77

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

1.33

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Interpretation of results:

irritating

Conclusions:

Based on the EU classification criteria Hostapon SG (25% Sodium N-Cocoyl Glycinate) is considered to be irritating to eye.

Executive summary:

Hostapon SG (25% Sodium N-cocoyl glycinate) was investigated for its eye irritation property according to OECD 405 and GLP. 0.1 mL of the test item was applied into the left conjunctival sac of 3 rabbits. The right eye served as a control. Assessments were made 1, 24, 48 and 72 hours p.a. as well as 7 days after treatment. No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity and iris were 0.00 for all three animals. The individual mean scores for the conjunctivae were 1.67, 2.00 and 1.67 for reddening and 2.00, 1.33 and 2.00 for chemosis, respectively. Slight to moderate reddening of the conjunctivae was noted in all animals 1 to 72 hours after treatment. Slight to marked swelling of the conjunctivae (chemosis with half-closed lids) was observed in all animals 1 to 72 hours after treatment. Moderate reddening of the sclera was present in one animal 1 to 72 hours after treatment. Due to the marked swelling (with halfclosed lids) of the conjunctivae, the assessment of the sclera was first prevented in two animals. When assessable at the 24-hour reading, a moderate reddening of the sclera was noted. Slight to moderate ocular discharge was recorded in all animals 1 to 72 hours after treatment. No abnormal findings were observed in the treated eye of any animal 7 days after treatment. No corrosion of the cornea was observed at any of the reading times. Based upon the results of this study, Hostapon SG is considered to be “irritating” to the rabbit eye.

Reference 3

Endpoint:

eye irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study according to GLP

Justification for type of information:

Justification is provided in Chapter 13.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan Netherlands BV
- Age at study initiation: 15 weeks (male), 16 weeks (females)
- Weight at study initiation: 2.4 kg (male), 2.5 - 2.6 kg (females)
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: yes

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 10 - 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hour dark / light cycle

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

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

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours

SCORING SYSTEM: numerical scoring system according Council Regulation (EC) 440/2008

TOOL USED TO ASSESS SCORE: fluorescein, diagnostic-lamp

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: no signs of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: no signs of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: no signs of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: no signs of irritation

Irritation parameter:

iris score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: no signs of irritation

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: no signs of irritation

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: no signs of irritation

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: no signs of irritation

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

1.77

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

1.67

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

1.67

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

1.77

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

1.33

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Interpretation of results:

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

Conclusions:

Eye damaging for 70% Hostapon SLG
Eye irritating for 25% Hostapon SLG

Executive summary:

The eye irritation of the registration substance Hostapon SLG was evaluated based on the read-across approach using the data for Hostapon SG.

Hostapon SG (25% Sodium N-Cocoyl Glycinate) was investigated for its eye irritation property by test material application to rabbits eyes. Mild to moderate reversible irritating effects were noted, meeting the criteria of " irritating" according to GHS. Hostapon SG (70% Sodium N-Cocoyl Glycinate) was investigated using bovine corneal ex-vivo model (BCOP). The obtained IVIS value is indicative of "eye damaging".

Likewise, Hostapon SLG (25% Sodium N-Lauroyl Glycinate) is eye irritating and Hostapon SLG (70% Sodium N-Lauroyl Glycinate) is eye damaging.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Justification for classification or non-classification

The skin irritaiton property of Hostapon SLG is derived based on the read-across to Hostapon SG:

No classification is assigned Hostapon SLG (25% Sodium N-Lauroyl Glycinate) and Hostapon SLG (70% Sodium N-Lauroyl Glycinate).

The eye irritation property of Hostapon SLG is derived based on the read-across to Hostapon SG:

Hostapon SLG (25% Sodium N-Lauroyl Glycinate) is to be classified as eye irritant (Eye Irrit 2); Hostapon SLG (70% Sodium N-Lauroyl Glycinate) is to be classified as eye damaging (Eye Dam 1).