Triphenylphosphine oxide

Endpoint summary

Description of key information

Skin irritation / corrosion

Skin irritation in vivo

The test item was determined to be not irritant to the skin of rabbit.

 

Eye irritation

Eye irritation in vivo

The test substance is not irritating to the eye of rabbit.

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Principles of method if other than guideline:

Skin irritation was tested using an internal standard method (BASF test). White Vienna rabbits were used. Usually, 2 animals were treated for 1, 5 and 15 minutes and two other animals for 20 hours using occlusive conditions. An application site of 2.5 X 2.5 cm was covered with the liquid or powdered and moistened test substance.

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: 2.66 -3.09 kg

ENVIRONMENTAL CONDITIONS
not reported

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: ca. 1 mL
- Concentration: 80 %

Duration of treatment / exposure:

Experiment 1: 1, 5, or 15 minutes
Experiment 2: 20 hrs

Observation period:

Experiment 1: up to 8 days
Experiment 2: up to 8 days

Number of animals:

2

Details on study design:

TEST SITE
- Area of exposure: An application site of 2.5 X 2.5 cm was covered with the liquid (37 °C; approx. 1 mL)

REMOVAL OF TEST SUBSTANCE
- Washing:
Experiment 1: washing was done in the 1 min, 5 min and 15 min test directly after exposure. Lutrol 50 % (mild detergent) was used.
Experiment 2: No washing was done after the 20 h treatment.

Descriptive scores of the raw data have been converted to Draize numerical scores.

Irritation parameter:

erythema score

Remarks:

20 h exposure

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Irritation parameter:

edema score

Remarks:

20 h exposure

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Irritant / corrosive response data:

No effects were also observed in the experiment with short term exposures (1, 5 and 15 min)

Interpretation of results:

not irritating

Conclusions:

In a study according to an internal method, the test item was determined to be not irritant to skin of rabbit.

Executive summary:

The skin irritation of the test item was assessed using an internal standard method (BASF test). White Vienna rabbits (weight at study initiation: 2.66 -3.09 kg) were used. Two animals were treated for 1, 5 and 15 minutes and two other animals for 20 hours using occlusive conditions. An application site of 2.5 X 2.5 cm was covered with the powdered and moistened test substance. An application site of 2.5 X 2.5 cm was covered (37 °C; approx. 1 mL of an 80 % test item solution; vehicle = water). The observation period was up to 8 days. In result, no effects were observed. Both the mean erythema score (20 h) and the mean edema score (20 h) was 0 (max score = 4). No effects were also observed in the experiment with short term exposures (1, 5 and 15 min). In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item is not irritant to skin.

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Principles of method if other than guideline:

Before OECD Guideline 405 was established, eye irritation was tested using an internal method (BASF test). White Vienna rabbits were used. Usually 50 µL or mg of the test substance were applied to the conjunctival sac of one eye of 2 animals. The talcum-treated adjacent eye served as a control.

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: 2.96 - 3.12 kg

ENVIRONMENTAL CONDITIONS
not reported

Vehicle:

unchanged (no vehicle)

Controls:

other: approx. 50 mg of talcum in the other eye

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 mg
- Concentration (if solution): pure

Duration of treatment / exposure:

Treatment was once. The eye was left unwashed.

Observation period (in vivo):

8 d

Number of animals or in vitro replicates:

2

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: not performed

SCORING SYSTEM: Descriptive scores of the raw data have been converted to Draize numerical scores.

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: no effects

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 8 d

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Animal	Reading	Opacity	Iritis	Redness	Chemosis	Comment
1	1 h	0	0	1	0	substance residues
2	1 h	0	0	1	0	substance residues
1	3 h	0	0	1	0
2	3 h	0	0	1	0
1	24 h	0	0	1	0
2	24 h	0	0	1	0
1	48 h	0	0	1	0
2	48 h	0	0	0	0
1	72 h	0	0	1	0
2	72 h	0	0	0	0
1	4 d	0	0	0	0
2	4 d	0	0	0	0
1	7 d	0	0	1	0
2	7 d	0	0	0	0
1	8 d	0	0	0	0
2	8 d	0	0	0	0
1	24 - 72 h	0.00	0.00	1.00	0.00
2	24 - 72 h	0.00	0.00	0.33	0.00
mean	24 - 72 h	0.00	0.00	0.67	0.00

Interpretation of results:

not irritating

Conclusions:

In a study with rabbits according to an internal method, the test item was not irritant to skin.

Executive summary:

The skin irritation of the test item was assessed according to an internal standard method (BASF test). White Vienna rabbits (weight at study initiation: 2.96 - 3.12 kg) were used. 50 mg of the undiluted test item were applied to the conjunctival sac of one eye of 2 animals. The talcum-treated adjacent eye served as a control. Washing of the eyes after treatment was not performed. Effects were scored 24, 48 and 72 hours after treatment. In result, the cornea opacity score (mean), iris score (mean) and the chemosis score was 0. The conjunctivae score (mean) was 0.67. Effects were fully reversible within 8 days. In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item is not irritant to eye.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation / corrosion

Skin irritation in vitro

An in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available.

Skin irritation in vivo

The skin irritation of the test item was assessed using an internal standard method (BASF test). White Vienna rabbits (weight at study initiation: 2.66 -3.09 kg) were used. Two animals were treated for 1, 5 and 15 minutes and two other animals for 20 hours using occlusive conditions. An application site of 2.5 X 2.5 cm was covered with powdered and moistened test substance. An application site of 2.5 X 2.5 cm was covered (37 °C; approx. 1 mL of an 80 % test item solution; vehicle = water). The observation period was up to 8 days. In result, no effects were observed. Both the mean erythema score (20 h) and the mean edema score (20 h) was 0 (max score = 4). No effects were also observed in the experiment with short term exposures (1, 5 and 15 min). In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item is not irritant to skin.

Eye irritation

Eye irritation in vitro

An in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available.

Eye irritation in vivo

The eye irritation of the test item was assessed according to an internal standard method (BASF test). White Vienna rabbits (weight at study initiation: 2.96 - 3.12 kg) were used. 50 mg of the undiluted test item were applied to the conjunctival sac of one eye of 2 animals. The talcum-treated adjacent eye served as a control. Washing of the eyes after treatment was not performed. Effects were scored 24, 48 and 72 hours after treatment. In result, the cornea opacity score (mean), iris score (mean) and the chemosis score was 0. The conjunctivae score (mean) was 0.67. Effects were fully reversible within 8 days. In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item is not irritant to eye.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

Based on the available experimental test data, the test substance is not considered to be classified for skin irritation/corrosion or eye irritation under Regulation (EC) No 1272/2008, as amended for the 12th time in Regulation (EU) 2019/521.