Registration Dossier

Administrative data

Description of key information

For the test item itself no studies are available concerning possible skin irritation properties. Therefore an in vivo study with read-across from a supporting substance (structural analogue or surrogate) is used, which was 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.

For the test item itself no studies are available concerning possible eye irritation properties. Therefore an in vivo study with read-across from a supporting substance (structural analogue or surrogate) is used, which was 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:
skin irritation in vivo
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:
Hostapon SG and acylglycinate GCK-12H-T are structurally closely related UVCB substances, which differ predominantly in the counterion (sodium resp. potassium). According to the available experimental studies, both substances exhibit results in a comparable range. Therefore, it can be assumed that the results obtained with Hostapon SG for this specific endpoint also apply to acylglycinate GCK-12H-T.
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals 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:
eye irritation in vivo
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:
Hostapon SG and acylglycinate GCK-12H-T are structurally closely related UVCB substances, which differ predominantly in the counterion (sodium resp. potassium). According to the available experimental studies, both substances exhibit results in a comparable range. Therefore, it can be assumed that the results obtained with Hostapon SG for this specific endpoint also apply to acylglycinate GCK-12H-T.
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
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 only 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

Additional information

Justification for classification or non-classification

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