Registration Dossier

Administrative data

Description of key information

The key studies were conducted to recognised testing guidelines, and with GLP certification.

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:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Only 9 day observation period
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
Acclimatization period: app. 8 days
One animal per cage (stainless steel with wire mesh walk floor, floor area: 40 cm x 51 cm).
Source: Gaukler, Offenbach/Main, FRG
Weight: 2.88 - 3.12kg
Room temperature: 20 - 26°C
Humidity: conventionally (about 30 - 70%)
Day/night rhythm: 12 h/12 h (6.00 - 18.00 hours/18.00 - 6.00 hours)
Diet: Ovator Solikanin 4 mm; Muskator-Werke Düsseldorf, FRG (about 130 g per animal per day)
Drinking water: About 250 ml per animal per day: fully demineralized water (Monday - Friday), tap water (Saturday/Sunday)
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): about 0.5ml

Duration of treatment / exposure:
4 hour
Observation period:
9 days
Number of animals:
3 (1male, 2 females)
Details on study design:
Application area: 2.5 cm x 2.5 cm
Application site: Upper third of the back or flank
Removal of the test substance at the end of the exposure period with Lutrol and Lutrol/water (1 : 1).
Readings: 30 - 60 minutes after removal of the test patches and 24 h, 48 h, and 9 d after the beginning of application.
Assessment according to Draize
Additional examinations: After sacrifice all animals are examined by gross pathology. If there are clinical signs of necroses, these are confirmed by gross-pathological examination after incision of the skin.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Interpretation of results:
GHS criteria not met
Conclusions:
The test material failed to induce dermal irritation under the conditions of the test.
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:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
only 8 day observation period
Qualifier:
according to
Guideline:
other: according to Fed. Reg. 38, No. 187, § 1500 42, p 27019 of Sept. 27, 1973
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
Acclimatization period: app. 8days
One animal per cage (stainless steel with wire mesh walk floor; floor area: 40 cm x 51 cm).
Source: Gaukler, Offenbach/Main, FRG
Average weight: males: 2.61kg, females: 2.81kg
Room temperature: 20 - 26°C
Relative humidity: conventionally (about 30 - 70%)
Day/night rhythm: 12 h/12 h (6.00 - 18.00 hours/18.00 - 6.00 hours)
Diet: Ovator Solikanin 4 mm; Muskator-Werke Düsseldorf, FRG (about 130 g per animal daily);
drinking water about 250 ml per animal daily - fully demineralized water (Monday - Friday) - tap water (Saturday/Sunday).
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
24 h
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
6 (3 males, 3 females)
Details on study design:
Application site: Conjunctival sac of the right eyelid
Readings: 1 h, 24 h, 48 h, 72 h, and 8 d after instillation
Assessment according to Draize
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0.05
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: 1-5
Time point:
24/48/72 h
Score:
>= 0.3 - <= 1.3
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible
Interpretation of results:
GHS criteria not met
Conclusions:
The test material failed to induce significant eye irritation under the conditions of the test.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In an acute dermal irritation or corrosion study similar to OECD 404, 0.5 ml of the test substance were topically applied to the intact skin of 3 White Vienna rabbits for 4 hours under occlusive dressing (BASF AG 1981). Skin reactions were scored 30 -60min, 24h, 48h, and 9days after removal of the test substance. No signs of irritation were observed. The score was 0 at all time points for erythema and edema.

6 white Vienna rabbits (3males, 3 females) were subjected to a single application of 0.1ml of the test substance into the conjunctival sac of one eye (BASF AG 1981) . The average scores (24 to 72h) were calculated to be 0.05 for corneal opacity, 0.0 for iris, 0.9 for conjunctivae redness (mainly due to one rabbit with score of 2), and 0.1 for chemosis. The findings were reversible in all animals within the 8 day observation period.

Justification for classification or non-classification

Based on the results of the available studies, ethyl phenyl(2,4,6-trimethylbenzoyl)phosphinate is not required to be classified for its skin or eye irritating potential according to 67/548/EEC and CLP/EU-GHS requirements.