Glycine, N-coco acyl derivs., sodium salts

Endpoint summary

Description of key information

A primary dermal irritation study comparable to OECD GL was conducted in rabbits. Based on a primary dermal irritation index (PDII) of 1.4, a significant skin irritation potential of the test item (5% w/w solution) is not to be expected.

In a second study the primary skin irritation potential of an aqueous solution of the test item “Hostapon SG” was investigated according to OECD GL 404 incl. GLP. Based on the obtained results, the test item was not regarded as a skin irritant according to EU classification criteria.

In a primary eye irritation study with rabbits according to OECD Guideline 405 incl. GLP, the test item caused a slight to mild opacity ranging from less than a quarter to the whole of the cornea, congestion in the iris, mild to moderate redness of the conjunctivae, slight to definite swelling, and mild to severe discharge 24 hours following administration of a 5% (w/w) solution. The irritations subsided with time, and the only irritation that was observed one week following administration was mild redness of the conjunctivae, which was observed in three cases. Based on the results of this study it was assessed that a 5% (w/w) solution of the test item was mildly irritating to rabbit eyes.

Also in a second study performed according to OECD Guideline 405 and GLP, the test item “Hostapon SG” was considered as mildly irritating to the rabbit eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1998

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

not specified

Specific details on test material used for the study:

Name: Sodium Cocoyl Glycinate (GCS-12)
Lot No.: 970925
Description: Clear liquid
Composition: 31.5% solution
Storage condition: Cool, dark place

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

not further specified

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

yes, concurrent vehicle

yes, concurrent positive control

Amount / concentration applied:

TEST MATERIAL
0.3 mL of a 5% (w/w) solution

VEHICLE
0.3 mL of distilled water for injection

POSITIVE CONTROL
0.3 mL of a 5% (w/w) SLS solution

Duration of treatment / exposure:

24 h

Observation period:

up to 1 week

Number of animals:

6 per group

Details on study design:

On the day before application, the hair on flank of the rabbits was shorn using electric hair clippers. Six healthy rabbits that did not have uneven hair growth were selected for the study.
On the day of application, 0.3 mL of distilled water for injection, 5% (w/w) test item or 5% (w/w) SLS solution was applied to the cotton area of a patch (2.5 cm in diameter) using a disposable syringe. The patch was then applied to the shorn area. Following application, the rabbits were fitted with a vest for 24 hours (closed patch testing). The vest and the patch were removed 24 hours following application. Thirty minutes later, the levels of erythema and edema at the test site were evaluated using the Draize scale.

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

7 d

Score:

1.4

Reversibility:

fully reversible within: 7 d

Remarks on result:

no indication of irritation

Interpretation of results:

GHS criteria not met

Conclusions:

Based on a primary dermal irritation index (PDII) of 1.4 it can be concluded that the test item (5% w/w solution) will not be irritant to the skin of rabbits.

Executive summary:

A primary dermal irritation study with the test item was conducted in rabbits using the Draize method (24 -hour occlusive patch). Based on a primary dermal irritation index (PDII) of 1.4, a significant skin irritation potential of the test item (5% w/w solution) is not to be expected.

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting 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:

other: 24h / 48h / 72h/

Score:

1.67

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

mean

Time point:

other: 24h / 48h / 72h

Score:

1.33

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean

Time point:

other: 24h / 48h / 72h

Score:

1.67

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

mean

Time point:

other: 24h / 48h / 72h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

mean

Remarks:

all animals

Time point:

other: 24h / 48h / 72h

Score:

1.11

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

mean

Time point:

other: 24h / 48h / 72h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

mean

Time point:

other: 24h / 48h / 72h

Score:

1.33

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

mean

Time point:

other: 24h / 48h / 72h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Other effects:

Scaling noted

Interpretation of results:

GHS criteria not met

Conclusions:

Hostapon SG as applied is not irritating to skin.

Executive summary:

The primary skin irritation potential of an aqueous solution of the registered UVCB substance (active content 25%) was investigated according to OECD test guideline no. 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 EU classification criteria.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

not specified

Specific details on test material used for the study:

Name: Sodium cocoyl glycinate (GCS-12)
Lot No.: 970925
Description: Clear liquid
Composition: 31.5% solution
Storage: Cool, dark place

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

not further specified

Vehicle:

water

Controls:

yes, concurrent vehicle

yes, concurrent positive control

Amount / concentration applied:

0.1 mL of a 5% (w/w) solution

Duration of treatment / exposure:

single application / not rinsed

Observation period (in vivo):

up to 1 week

Number of animals or in vitro replicates:

6 per group

Details on study design:

Prior to application, both eyes of each rabbit were macroscopically examined to select healthy rabbits with eyes that were free from disease and injury in the cornea, iris and conjunctivae. The animals were then assigned to 3 groups: vehicle control (distilled water for injection), test item (5% solution) and positive control (5% SLS solution). On the day of application, each rabbit was restricted using an animal holder, and 0.1 mL of the test solution was applied using a disposable syringe to the right eye by pulling the lower eyelid into a cup-shape. Both eyelids were held together for two to three seconds following application. The left eye was designated the non-treatment control. The cornea, iris, conjunctivae and discharge were evaluated using the Draize scale 24, 48, 72 and 96 hours, and one week following application.

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24 h

Score:

41.3

Remarks on result:

probability of mild irritation

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

7 d

Score:

1

Remarks on result:

probability of mild irritation

Interpretation of results:

Category 2B (mildly irritating to eyes) based on GHS criteria

Conclusions:

Based on the results of this study it was assessed that a 5% w/w solution of the test item was mildly irritating to rabbit eyes.

Executive summary:

In a primary eye irritation study with rabbits, the test item was evaluated using the Draize scale and classified using the Kay and Calandra classification criteria. Slight to mild opacity ranging from less than a quarter to the whole of the cornea, congestion in the iris, mild to moderate redness of the conjunctivae, slight to definite swelling, and mild to severe discharge were observed 24 hours following administration of a 5% (w/w) solution. The irritations subsided with time, and the only irritation that was observed one week following administration was mild redness of the conjunctivae, which was observed in three cases. Based on the results of this study it was assessed that a 5% (w/w) solution of the test item was mildly irritating to rabbit eyes.

Reference 2

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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:

other: 24h / 48h / 72h

Score:

0

Max. score:

0

Reversibility:

other: no signs of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

mean

Time point:

other: 24h / 48h / 72h

Score:

0

Max. score:

0

Reversibility:

other: no signs of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

mean

Time point:

other: 24h / 48h / 72h

Score:

0

Max. score:

0

Reversibility:

other: no signs of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

mean

Time point:

other: 24h / 48h / 72h

Score:

0

Max. score:

0

Reversibility:

other: no signs of irritation

Irritation parameter:

iris score

Basis:

mean

Remarks:

all animals

Time point:

other: 24h / 48h / 72h

Score:

0

Max. score:

0

Reversibility:

other: no signs of irritation

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

mean

Time point:

other: 24 h / 48 h / 72h

Score:

0

Max. score:

0

Reversibility:

other: no signs of irritation

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

mean

Time point:

other: 24h / 48h / 72h

Score:

0

Max. score:

0

Reversibility:

other: no signs of irritation

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

mean

Time point:

other: 24h / 48h / 72h

Score:

0

Max. score:

0

Reversibility:

other: no signs of irritation

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

all animals

Time point:

other: 24h / 48h / 72h

Score:

1.77

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #1

Remarks:

mean

Time point:

other: 24h / 48h / 72h

Score:

1.67

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #2

Remarks:

mean

Time point:

other: 24h / 48h / 72h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #3

Remarks:

mean

Time point:

other: 24h / 48h / 72h

Score:

1.67

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

all animals

Time point:

other: 24h / 48h / 72h

Score:

1.77

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

mean

Time point:

other: 24h / 48h / 72h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

mean

Time point:

other: 24h / 48h / 72h

Score:

1.33

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

mean

Time point:

other: 24h / 48h / 72h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Interpretation of results:

Category 2B (mildly irritating to eyes) based on GHS criteria

Conclusions:

Based on the EU classification criteria Hostapon SG as applied is considered to be irritating to the rabbit eye.

Executive summary:

The test item was tested for primary eye irritation 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 mildly irritating to the rabbit eye.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The test item gave no indications for possible skin irritation/corrosion in experimental animals. Therefore, there is no need for classification and labelling of the test item according to EU CLP Regulation 1272/2008/EG.

In tests concerning possible eye irritation/corrosion, the noted effects in experimental animals were only mild and reversible. Therefore, there is no need for classification and labelling of the test item according to EU CLP Regulation 1272/2008/EG.