Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted Feb. 1987
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
adopted May 2008
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Version / remarks:
adopted August 1998
Qualifier:
according to guideline
Guideline:
other: Japan MAFF Testing Guideline of 12 Nosan No. 8147
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl phenyl(2,4,6-trimethylbenzoyl)phosphinate
EC Number:
282-810-6
EC Name:
Ethyl phenyl(2,4,6-trimethylbenzoyl)phosphinate
Cas Number:
84434-11-7
Molecular formula:
C18H21O3P
IUPAC Name:
ethyl phenyl(2,4,6-trimethylbenzoyl)phosphinate
Details on test material:
- Name of test material (as cited in study report): Lucirin TPO-L
- Physical state: Liquid, viscous /yellow, clear
- Analytical purity: 95.7g/100g determined by H-NMR spectroscopy
- Purity test date: 2013-04-16
- Lot/batch No.: Mischung 120204
- Expiration date of the lot/batch: May 29th, 2015
- Storage condition of test material: Room temperature; under light exclusion

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, 97633 Sulzfeld, Germany
- Age at study initiation: males: app. 8 weeks, females app. 12 weeks
- Weight at study initiation: males: 229g, females 208g, on average
- Fasting period before study: no
- Housing: single in Makrolon type III cages
- Diet (e.g. ad libitum): VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12h/12h

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: at least 10% of total body surface
- Type of wrap if used: 4 layers of absorbent gauze and stretch bandage (Fixomull® Stretch (adhesive fleece)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing with warm water after removal of the dressing
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.77ml/kg
Duration of exposure:
24h
Doses:
2000mg/kg b.w.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: several times on the day of administration, daily thereafter
- Frequency of weighing: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: Scoring of skin findings according to Draize 30-60minutes after removal of the dressing

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality occured
Mortality:
none
Clinical signs:
none
Body weight:
expected increase
Gross pathology:
no abnormalities detected
Other findings:
no local effects

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the test the acute dermal LD50 of the registered substance was found to be ≥2000 mg/kg bw in the rat.