Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2011-06-29 to 2011-07-21
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline compliant 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:
(February 24, 1987)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
(30 May 2008)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Version / remarks:
(August 1998)
Deviations:
no
Qualifier:
according to
Guideline:
other: Japan MAFF Testing Guideline of 12 Nosan No. 8147 as this in line with OECD 402
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: colourless liquid

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: Male animals approx. 8 weeks, female animals approx. 12 weeks
- Weight at study initiation: Group 1 male: 228-244 g; Group 2 female: 196-210 g (± 20% of the mean weight)
- Housing: Single housing, Makrolon cage, type III
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany)
- Water: Tap water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30–70
- Air changes: Fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 6.00 a.m.–6.00 p.m.

Administration / exposure

Vehicle:
olive oil
Remarks:
Ph.Eur.
Details on dermal exposure:
TEST SITE
- Area of exposure: Dorsal and dorsolateral parts of the trunk
- % coverage: About 40 cm² (corresponds to at least 10% of the body surface)
- Type of wrap if used: Semi-occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Warm water
- Time after start of exposure: Afterwards removal of the semi- occlusive dressing

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 8.33 mL/kg bw
- Concentration (if solution): 60 g/100 mL
- Constant volume or concentration used: Yes
- For solids, paste formed: No

VEHICLE
- Amount(s) applied: 100 mL
Duration of exposure:
24 hours
Doses:
5000 mg/kg bw
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 and weighing: Observations everday; Body weight: Day 0, 7,14
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, scoring of skin findings

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
No systemic clinical signs were observed during clinical examination.
Body weight:
The mean body weight of the male animals increased within the normal range throughout the study period.
The mean body weight of the female animals did not adequately increase during the first post-exposure observation week, but increased during the second week. This reduced weight gain in females during the first week is considered to be incidental and not treatment related as no other effects were observed in all treated animals of all dose groups.
Gross pathology:
No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined on the last day of observation.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information