Tris(2,4-ditert-butylphenyl) phosphite

Endpoint summary

Description of key information

Test substance was found to be non-irritant to skin or eyes as tested in rabbits in protocols equivalent or similar to OECD 404 and 405.

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:

1975-06

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

14 h/d light period. Occlusive dressing. Vehicle not specified. Dose not specified. 24 h exposure.

Qualifier:

according to guideline

Guideline:

other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).

GLP compliance:

no

Species:

rabbit

Strain:

other: Russian

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 1.5 - 2 kg
- Housing: individually in metal cages
- Diet (e.g. ad libitum): ad libitum, standard rabbit food (NAFAG, Gossau SG)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 10 / 14

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: not mentioned

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): not specified

VEHICLE
- Amount(s) applied (volume or weight with unit): not specified

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

6 (3 males and 3 females)

Details on study design:

TEST SITE
- Area of exposure: entire back and the flank
- Type of wrap if used: impermeable material fastened to the body of the rabbit with adhesive tape

SCORING SYSTEM: Draize

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 h

Score:

0

Max. score:

8

Reversibility:

fully reversible

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 72 h

Score:

0

Max. score:

8

Reversibility:

fully reversible

Other effects:

none reported

Interpretation of results:

GHS criteria not met

Conclusions:

The primary irritation index, a measure of the acute irritation to the rabbit skin was 0. This indicates that the substance is not an irritant to the rabbit 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

Study period:

1975-06

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) , the US Association of Food and Drug Officials (AFDO).

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

14 h/d light period. The eyes of three animals were washed after 30 s from treatment without justification.

GLP compliance:

no

Species:

rabbit

Strain:

other: Russian

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 1.5 - 2 kg
- Housing: individually in metal cages
- Diet (e.g. ad libitum): ad libitum, standard rabbit food (NAFAG, Gossau SG)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 10 / 14

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

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

Duration of treatment / exposure:

30 s (3 rabbits)

Observation period (in vivo):

7 d

Number of animals or in vitro replicates:

6 (3 males and 3 females)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm water (3 animals)
- Time after start of exposure: 30 s

SCORING SYSTEM:
Draize

TOOL USED TO ASSESS SCORE:
hand-slit lamp

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1 d

Score:

0

Max. score:

110

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 2 d

Score:

0

Max. score:

110

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 3 d

Score:

0

Max. score:

110

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 4 d

Score:

0

Max. score:

110

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 7 d

Score:

0

Max. score:

110

Other effects:

none reported

Interpretation of results:

GHS criteria not met

Conclusions:

The irritation index in this experiment was established to be 0 for the cornea, 0 for the iris and 0 for the conjunctivae.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Test substance was evaluated for its irritating properties on skin and eyes of rabbits (Ciba-Geigy, 1975). The procedures used was the test for skin and eye irritants described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO). This is more stringent than the current OECD testing guideline case of the skin irritation study and comparable in the case of the eye irritation study.

Two days before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on the left side was slightly abraded. For treatment gauze patches of 2.5 x 2.5 cm soaked with the test substance were applied to the prepared abraded and non-abraded skin. The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape. The dressings were removed after a 24 hour exposure. The skin irritation was scored immediately and 48 hours after removal of the dressings (24 and 72 hours after initiation of treatment). The primary skin irritation index in this experiment was established to be 0.

The test material in amounts of 0.1 g was inserted into the conjunctival sac of the left eye of 6 rabbits and the lids were gently held open for one second. The right eye remained untreated and served as a control. In 3 rabbits about 30 seconds after administration the treated eyes were flushed with 10 ml lukewarm water. The eye irritation was appraised with a slit-lamp at day 1, 2, 3, 4 and 7. The primary eye irritation index represents the sum of the mean values for cornea, iris and conjunctivae at day 1, 2, 3, 4 and 7. The irritation index was established to be 0 for the cornea, 0 for the iris and 0 for the conjunctivae.

 

No data are available for respiratory irritation. In the absence of adverse findings on skin and in eyes, respiratory irritation is not expected.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result, the substance is not considered to be classified for skin and eye irritation under Regulation (EC) No. 1272/2008.