[No public or meaningful name is available]

Endpoint summary

Description of key information

- Skin irritation: based on available data (OECD 404, Kr. 2, GLP), the test substance is considered as not irritating to skin.
- Eye irritation: based on available data (OECD 405, Kr. 2, GLP), the test substance is considered as irritating to eyes.
- Respiratory irritation: no data available.

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:

2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP Study, OECD compliance. however, no cerficate of analysis is available in the study report

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

2000-04-26

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12 to 16 weeks
- Weight at study initiation: 2.50 to 2.75 kg
- Housing: Individually housed in suspended metal cages
- Diet (e.g. ad libitum): free access to food (STANRAB SQC Rabbit diet, special diets services Ltd, witham, Essex, UK)
- Water (e.g. ad libitum): free access
- Acclimation period: At least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17°C to 23°C
- Humidity (%): 30% to 70%
- Air changes (per hr): At least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): Cycle 12/12 (Continuous light fromm 6:00 to 18:00)

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

1h, 24h, 48h and 72h after the removal of the patch

Number of animals:

3 males

Details on study design:

TEST SITE
the substance was introduced under a 2.5cm x 2.5 cm cotton gauze patch and placed in position on the short skin. The patch was secured in position with a strip of surgical adhesive tape. To prevent the animal interfering with the patches, the trunk of each rabbit wrapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
Four hours after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.

SCORING SYSTEM:
Draize method

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Very slight erythema was noted at two treated skin sites at the 1-hour observation.
An isolated incident of very slight oedema was noted at one treated skin site at the 1-hour observation.

Table 73.1/1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Skin Reaction	Observation time	Individual Scores- Rabbit Number and Sex (BW : Kg)			Total
		178 Male (2.75)	94 Male (2.50)	58 Male (2.73)
Erythema / Eschar formation	1 hour	0	1	1	(2)
	24 hours	0	0	0	0
	48 hours	0	0	0	(0)
	72 hours	0	0	0	0
Oedema Formation	1 hour	0	0	1	(1)
	24 hours	0	0	0	0
	48 hours	0	0	0	(0)
	72 hours	0	0	0	0
Sum of 24 and 72 hour reading (S) : 0
Primary Irritation Index (S/6): 0/6 = 0.0
Classification: NON-IRRITANT

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions of this study, no dermal irritation was elicited by the test substance application throughout the observation period in any animal. The scores for both erythema and oedema are 0 for all animals. Therefore, the test substance is considered as not irritating to skin.

Executive summary:

In a primary dermal irritation study performed according to the OECD 404 guidelines and in compliance with GLP, three animals (males) were dermally exposed to 0.5mL of ALBRITE CS1 for 4 hours (Albrite CS1 was the commercial name of Phosphonium, tetrakis (hydroxymethyl)-sulphate (2:1); polymer with urea).

Cutaneous reactions were observed approximately 1, 24, 48 and 72 hours after removal of the dressing. The mean values of the scores for erythema and oedema were calculated for each animal.

No dermal irritation was elicited by product application throughout the observation period in any animal. The scores for both erythema and oedema are 0 for all animals.The substance seems not to be irritant via skin exposure.

Under the test conditions of this study, the substance ALBRITE CS1 (Phosphonium, tetrakis (hydroxymethyl)-sulphate (2:1); polymer with urea) was considered as not irritating to skin and not classified according to the criteria of the CLP Regulation (EC) N°1272/2008.

 

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not 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:

2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP study, OECD compliance. However, no certificate of analysis are available

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

Not applicable.

GLP compliance:

yes (incl. QA statement)

Remarks:

2000-04-26

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12 to 16 years old
- Weight at study initiation: 2.65 to 3.26 kg
- Housing: Individually housed in suspended metal cages
- Diet (e.g. ad libitum): free access to STANRAB SQC Rabbit diet, special diet services Ltd, Witham, Essex, UK
- Water (e.g. ad libitum): Free access

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 °C to 23 °C
- Humidity (%): 30 % to 70 %
- Air changes (per hr): 15 changes per hour
- Photoperiod (hrs dark / hrs light): cycle 12h/12h. Light from 6am to 6 pm

Vehicle:

unchanged (no vehicle)

Controls:

other: left eye

Amount / concentration applied:

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

Observation period (in vivo):

1, 24, 48 and 72 hours. 7 and 14 days

Number of animals or in vitro replicates:

3 (1 female and 2 males)

Details on study design:

Immediately before the start of the test, both eyes of the provisionally selected test rabbits were examinated for evidence of ocular irritation or defect with the aid of a light source from a standard ophtalmoscope. Only animals free of ocular damage were used.

Initially, a single rabbit was treated. A volume of 0.1 mL of the test material was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about 1 second immediately after treatment to prevent loss of test material, and then released. The left eye remained untreated and was used for control purposes.

After consideration of the ocular responses produced in the first treated animal, 2 additional animals were treated. In order to minimise pain on application of the test material, one drop of local anaesthesic (Amethocaine hydrochloride 0.5% Chauvin Pharmaceuticals, Romford, Essex, UK) was instilled into both eyes of all animals 1 to 2 minutes before treatment.

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other:

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.66

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 14 days

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 14 days

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 14 days

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.66

Max. score:

4

Reversibility:

fully reversible within: 14 days

Individual Scores and Individual Total Scores for Ocular Irritation

Rabbit Number and Sex BW: kg	128 Female (3.26) +						116 Male (3.03) +					117 Male (2.65) +
Time after treatment	1h	24h	48h	72h	7d	14d	1h	24h	48h	72h	7d	1h	24h	48h	72h	7d
CORNEA
E = Degree of opacity	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0
F = Area of opacity	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Score (E x F) x 5	0	5	5	0	0	0	0	0	0	0	0	0	0	0	0	0
IRIS
D	0	1	1	0	0	0	0	1	0	0	0	0	0	0	0	0
Score (D x 5)	0	5	5	0	0	0	0	5	0	0	0	0	0	0	0	0
CONJUNCTIVAE
A = Redness	2	2P	2P	2P	2P	0	2	2	2	2	0	2	2	2	2	0
B = Chemosis	2	2	2	2	1	0	2	2	2	2	0	1	2	2	1	0
C = Discharge	2	2	2	2	1	0	1	2	2	2	0	2	2	2	2	0
Score (A + B + C) x 2	12	12	12	12	8	0	10	12	12	12	0	10	12	12	10	0
Total Score	12	22	22	12	8	0	10	17	12	12	0	10	12	12	10	0

+ = One drop of Amethocaine hydrochloride instilled into each eye 1 to 2 minutes prior to dosing

P = Pale appearance of the nictating membrane

Individual Total Scores and Group Mean Scores for Ocular Irritation

Rabbit Number	Individual Total Scores at:
	1h	24h	48h	72h	7 days
128	12	22	22	12	0
116	10	17	12	12	0
117	10	12	12	10	0
Group total	32	51	46	34	8
Group Mean score	10.7	17.0	15.3	11.3	2.7

 

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Under the test conditions of this study, The mean individual scores were 0.66/0.0/0.0, 0.66/0.33/0.0, 2.0/2.0/2.0 and 2.0/2.0/1.66 for cornea, iris, conjunctivae redness and chemosis respectively. These effects were reversible after 14 days. Based on these results, the test substance is considered as irritating to eyes.

Executive summary:

In an eye irritation study performed according to the OECD No. 405 guideline and in compliance with the GLP, 0.1 mL of undiluted Albrite CS1 (commercial name of Phosphonium, tetrakis (hydroxymethyl)-sulphate (2:1); polymer with urea) was instilled into the conjunctival sac of the right eye of 3 New Zealand White rabbits. The eyes were not rinsed after administration of the test substance.

Ocular reactions were observed approximately 1, 24, 48 and 72 hours, 7 and 14 days after the administration.The mean individual score were calculated within 3 scoring times (24, 48 and 72 hours).

The mean individual scores were 0.66/0.0/0.0, 0.66/0.33/0.0, 2.0/2.0/2.0 and 2.0/2.0/1.66 for cornea, iris, conjunctivae redness and chemosis respectively. These effects were reversible after 14 days.

Under the test conditions of this study, i Albrite CS1 (commercial name of Phosphonium, tetrakis (hydroxymethyl)-sulphate (2:1); polymer with urea) s considered as irritating to eyes.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

- Skin irritation: one study was available for this endpoint and considered as the key study (DJ Allen, 2000). This study was performed according to the OECD test guideline No. 404 and in compliance with GLP (Reliability: 1). Three New Zealand rabbits were dermally exposed to 0.5 mL of ALBRITE CS1 for 4 hours (Albrite CS1 was the commercial name of Phosphonium, tetrakis (hydroxymethyl)-sulphate (2:1); polymer with urea). Cutaneous reactions were observed approximately 1, 24, 48 and 72 hours after removal of the dressing. The mean values of the scores for erythema and oedema were calculated for each animal.

No dermal irritation was elicited by product application throughout the observation period in any animal. The scores for both erythema and oedema are 0 for all animals.The substance seems not to be irritant via skin exposure.

Under the test conditions of this study, the substance ALBRITE CS1 (Phosphonium, tetrakis (hydroxymethyl)-sulphate (2:1); polymer with urea) was considered as not irritating to skin.

- Eye irritation: one study was available for this endpoint and considered as the key study (DJ Allen, 2000). This study was performed according to the OECD test guideline No. 405 guideline and in compliance with the GLP (Reliability: 1).

In this study, 0.1 mL of undiluted Albrite CS1 (commercial name of Phosphonium, tetrakis (hydroxymethyl)-sulphate (2:1); polymer with urea)

was instilled into the conjunctival sac of the right eye of 3 New Zealand White rabbits. The eyes were not rinsed after administration of the test substance. Ocular reactions were observed approximately 1, 24, 48 and 72 hours, 7 and 14 days after the administration.

The mean individual scores were 0.66/0.0/0.0, 0.66/0.33/0.0, 2.0/2.0/2.0 and 2.0/2.0/1.66 for cornea, iris, conjunctivae redness and chemosis respectively. These effects were reversible after 14 days. Therefore, the test substance is considered as irritating to eyes.

Justification for selection of skin irritation / corrosion endpoint:
Only one study was available and considered as the key study (OECD 404, Kr.2 , GLP).

Justification for selection of eye irritation endpoint:
Only one study was available and considered as the key study (OECD 405, Kr.2 , GLP).

Effects on eye irritation: irritating

Justification for classification or non-classification

- Skin irritation:

No dermal irritation was elicited by product application throughout the observation period in any animal. The scores for both erythema and oedema are 0 for all animals (3 males).Therefore, the test substance is considered as not irritating to skin ans not classified according to the criteria of the CLP Regulation (EC) N°1272/2008.

- Eye irritation:

The mean individual scores were 0.66/0.0/0.0, 0.66/0.33/0.0, 2.0/2.0/2.0 and 2.0/2.0/1.66 for cornea, iris, conjunctivae redness and chemosis respectively. These effects were reversible after 14 days. Therefore, the test substance is considered as irritating to eyes and classified into category 2.

(H319) according to the criteria of the CLP Regulation (EC) N°1272/2008.