Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted Feb. 24th, 1987
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
May 30th, 2008
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Version / remarks:
August 1998
Qualifier:
according to
Guideline:
other: Japan MAFF Testing Guideline of 12 Nosan No. 8147
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Lucirin TPO
- Physical state: yellowish solid
- Analytical purity: 99.5% (w/w) (for details see analytical report 11L00292)
- Purity test date: 2011-09-08
- Lot/batch No.: 110053
- Expiration date of the lot/batch: 2015-07-19
- Stability under test conditions: guaranteed by sponsor
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: males: app. 8 weeks, females: app. 12 weeks
- Weight at study initiation: males: 230.8g +/- 13.2g, females 204.8g +/- 3.1g
- Housing: single in Markolon type III cages
- Diet (e.g. ad libitum): VRF1(P); SDS Special Diets Services, Altrip, Germany
- Water (e.g. ad libitum): tap water ad lib.
- Acclimation period: at least 5 days

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

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
olive oil
Details on dermal exposure:
TEST SITE
- Area of exposure: app. 40cm²
- Type of wrap if used: air-permeable dressing (4 layers of absorbent gauze (Ph. Eur. supplied by Lohmann GmbH & Co., KG) and stretch bandage (Fixomull® Stretch (adhesive fleece) supplied by Beiersdorf AG

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, using warm water
- Time after start of exposure: 24h, right after removal of the dressing

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5ml/kg b.w.
- Concentration (if solution): 40%
- For solids, paste formed:no (suspension)
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 exposure, once every workday thereafter
- Frequency of weighing: weekly, beginning on day 0
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, skin reactions according to Draize

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:
no mortality occured
Clinical signs:
no systemic toxicity was observed, local skin irritation was observed in 1 male and all females (details on severity in tables 1+2)
Body weight:
The mean body weight of the male animals increased within the normal range throughout the study period.
Mean body weight of the female animals did not adequately increase during the first post-exposure observation week, probably due to the bandage procedure, but increased during the second week within the normal range.
Gross pathology:
no abnormalities

Any other information on results incl. tables

Table 1: Skin irritation males

Animal No.: R 40 R 41 R 42 R 43 R 44
Erythema grade 1: - - d7 - d10 - -
Erythema grade 2: - - d2 - d6 - -
Incrustations: - - d6 - d14 - -
Scaling: - - d6 - d7 - -

Table 2: Skin irritation females

Animal No.: R 45 R 46 R 47 R 48 R 49
Erythema grade 1: d1 - d6 d6 - d7 d8 - d14 d6 - d7 d3 - d6
Erythema grade 2: - d1 - d3 d1; d6 - d7 d1 - d3 d1 - d2
Erythema grade 3: - - d2 - d3 - -
Incrustations: - - d6 - d14 - -
Scaling: - d6 - d8 d6 - d14 d6 - d8 d6 - d7

d: day

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
Under the conditions of this study the median lethal dose (LD50) of the test substance after single dermal application was found to be greater than 2000 mg/kg bw in male and female rats.