Registration Dossier

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

Referenceopen allclose all

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:
other: Federal Register 38, No 187, §1500 .41, p27029, 27 Sept 1973
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals 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:
not irritating
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

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:
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
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.