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EC number: 278-355-8 | CAS number: 75980-60-8
Endpoint summary
Administrative data
Description of key information
Skin:
Rabbit, 24h, occlusive: not irritating (BASF 1979, according to Federal Register 38, No. 187, § 1500.41)
Eye:
Rabbit: not irritating (BASF 1979, according to Federal Register 38, No. 187, § 1500.42)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
- 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:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Register 38, No 187, §1500 .41, p27029, 27 Sept 1973
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler
- Age at study initiation: not reported
- Weight at study initiation: mean 3.04 kg for male, 3.12 for female
- Diet: Ssniff from the company INTERMAST, ad libitum
- Water: ad libitum - Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded and intact
- Vehicle:
- water
- Controls:
- other: untreated skin of same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 50% in water - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 8 days (observations at 24h, 48h, 72h, and day8)
- Number of animals:
- 2 males and 4 females
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
SCORING SYSTEM: as described in OECD guideline 404 - Irritation parameter:
- erythema score
- Remarks:
- intact application site
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: mean 24-48-72-hour score for abraded application site was 1, fully reversible within 72 hours
- Irritation parameter:
- edema score
- Remarks:
- intact application site
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: mean 24-48-72-hour score for abraded application site was 0.67, fully reversible within 48 hours
- Irritation parameter:
- erythema score
- Remarks:
- intact application site
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: mean 24-48-72-hour score for abraded application site was 0.33, also fully reversible within 48 hours
- Irritation parameter:
- edema score
- Remarks:
- intact application site
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: mean 24-48-72 hour score for abraded application site was also 0
- Irritation parameter:
- erythema score
- Remarks:
- intact application site
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: mean 24-48-72-hour score for abraded application site was 1.33, fully reversible within 8 days
- Irritation parameter:
- edema score
- Remarks:
- intact application site
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: mean 24-48-72-hour score for abraded application site was 0.67, also fully reversible within 48 hours
- Irritation parameter:
- erythema score
- Remarks:
- intact application site
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- ca. 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: mean 24-48-72-hour score for abraded application site was 1, fully reversible within 72 hours
- Irritation parameter:
- edema score
- Remarks:
- intact application site
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: mean 24-48-72-hour score for abraded application site was 0.33, also fully reversible within 48 hours
- Irritation parameter:
- erythema score
- Remarks:
- intact application site
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: mean 24-48-72-hour score for abraded application site was 1.33, fully reversible within 8 days
- Irritation parameter:
- edema score
- Remarks:
- intact application site
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: mean 24-48-72-hour score for abraded application site was 0.67, fully reversible within 48 hours
- Irritation parameter:
- erythema score
- Remarks:
- intact application site
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: mean 24-48-72-hour score for abraded application site was 0.33, also fully reversible within 48 hours
- Irritation parameter:
- edema score
- Remarks:
- intact application site
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: mean 24-48-72-hour score for abraded application site was also 0
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Remarks:
- of the 6 tested anmals
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Remarks:
- intact application site
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours in 5 animals or 8 days in one animal
- Remarks on result:
- other: mean 24-48-72-hour score for abraded application site was 0.9, also fully reversible within 72 hours in 5 animals or 8 days in 1 animal
- Irritation parameter:
- edema score
- Remarks:
- intact application site
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: mean 24-48-72-hour score for abraded application site was 0.4, also fully reversible within 48 hours
- Other effects:
- No signs of systemic toxicity observed during necropsy.
- Interpretation of results:
- GHS criteria not met
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
- 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:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Register 38, No 187, §1500.42, p27019, 27 Sept 1973
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler
- Age at study initiation: not reported
- Weight at study initiation: mean 2.60 kg for male, 2.94 for female
- Diet: Ssniff from the company INTERMAST, ad libitum
- Water: ad libitum - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated left eye of the same animal
- Amount / concentration applied:
- TEST MATERIAL
Amount applied: 56 mg (corresponding to 0.1 ml bulk volume) - Duration of treatment / exposure:
- test substance was not washed
- Observation period (in vivo):
- 5 days
(observations after 24, 48, 72h, 5d) - Number of animals or in vitro replicates:
- 4 females and 2 males
- Details on study design:
- SCORING SYSTEM: Draize
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of all test animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of all test animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animals #1,3,5,6
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- other: redness score was 2 in all test animals after 1 h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animals #2,4
- Time point:
- 24/48/72 h
- Score:
- >= 0.6 - <= 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- other: redness score was 2 in all test animals after 1 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of all test animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: chemosis score was 1 in all test animals after 1 h
- Irritation parameter:
- other: conjunctiva discharge
- Basis:
- mean
- Remarks:
- all test animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: conjunctiva discharge score was 2 in all test animals after 1 h
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide was shown not to be neither a skin nor an eye irritant.
In a guideline study 0.5g of the test substance were applied to the intact and abraded skin of 6 White Vienna rabbits for 24h under occlusive conditions. On the intact skin, with the exception of grade 1 erythema in one rabbit after 48h, mild skin reaction (erythema grade 1 in 4 rabbits, grade 2 in 2 rabbits and edema grade 1 and 2 in one rabbit each) were only observed after 24h, right after removal of the occlusive dressing. On the abraded skin, grade 1 erythema persisted in 2 rabbits up to 72h.
In an in vivo study 0.65g of the test substance (app. 0.1ml) were applied to one eye each of 6 White Vienna rabbits. After 24h, and in 2 animals also after 48h, slight conjunctival redness was observed (grade 1 in 5 animals, grade 1 in one animal after 24h). No further substance related effects were observed.
Justification for classification or non-classification
The available data indicate no skin or eye irritating potential of diphenyl(2,4,6 -trimethylbenzoyl)phosphine oxide, thus no classification according to 67/548/EEC or CLP/EU-GHS is justified.
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