Fatty acids, coco derivs., reaction products with glycine, potassium salts

Endpoint summary

Description of key information

In an in vivo study with a structural analogue or surrogate of the test item performed with New Zealand White rabbits according to OECD test guideline no. 404, the application to the skin resulted in mild to moderate signs of irritation. 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 substance was not regarded a skin irritant according to EU classification criteria.

In an in vivo study with a structural analogue or surrogate of the test item performed with New Zealand White rabbits according to OECD test guideline no. 405, 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.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation / corrosion, other

Remarks:

in vivo study

Type of information:

other: 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:

As Hostapon SG and acylglycinate GCK-11-T differ only in the counterion (sodium-potassium), it can be assumed that the results obtained with Hostapon SG also apply to acylglycinate GCK-11-T.

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

Endpoint:

eye irritation, other

Remarks:

in vivo study

Type of information:

other: 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:

As Hostapon SG and acylglycinate GCK-11-T differ only in the counterion (sodium-potassium), it can be assumed that the results obtained with Hostapon SG also apply to acylglycinate GCK-11-T.

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:

GHS criteria not met

Conclusions:

Based on the EU classification criteria Hostapon SG as applied is considered as very mildly irritating to the rabbit eye. All effects were reversible.

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.

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 caused only slight skin and eye irritation in studies with experimental animals. As all effects were reversible, there is no need for classification and labelling of the test item according to CLP Regulation 1272/2008/EG.