Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14 January 2010 to 3 February 2010 (in-life phase)
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study undertaken according to current OECD and EU Test Guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, Acute dermal toxicity (2-1-2), 12 Nohsan No 8147, Agricultural Production Bureau, November 24, 2000.
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): Oxooil LS9
- Substance type: Industrial
- Physical state: liquid
- Analytical purity: 95.3%
- Impurities (identity and concentrations): no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: 13.06.2008 0649/82531
- Expiration date of the lot/batch: 8 June 2010
- Stability under test conditions: no data
- Storage condition of test material: refrigerated, in the dark

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd.
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 207 to 339 g
- Fasting period before study: none
- Housing: individually in solid bottomed polycarbonate cages
with a stainless steel mesh lid
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23°C
- Humidity (%): 40-70 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light

IN-LIFE DATES: From: 14 January 2010 (animal allocation) To: 3 February 2010 (terminal necropsy)

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorso-lumbar region (approximately 50 mm x 50 mm)
- % coverage: 10% of total body surface area
- Type of wrap if used: porous gauze held in place with a non-irritating dressing, and further covered by a waterproof dressing encircled firmly around the trunk of the animal

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.74 ml/kg bodyweight
- Constant volume or concentration used: test material used as supplied (SG 0.73 g/ml)

Duration of exposure:
24 hours
Doses:
2000 mg/kg bodyweight
No. of animals per sex per dose:
5 male and 5 female animals
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1. On subsequent days, animals were observed once in the morning and again at the end of the experimental day (with the exception of Day 15 - morning only). Local dermal irritation at the treatment site was assessed daily. The weight of each rat was recorded on Days 1 (prior to dosing), 8 and 15.
- Necropsy of survivors performed: yes
Statistics:
Not undertaken

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
0/5 males and 0/5 females
Clinical signs:
There were no clinical signs considered to be related to treatment.
There were no deaths and no clinical signs considered to be related to treatment.
Very slight or well-defined erythema was observed in four males and three females from
Day 2. These reactions had resolved in all animals by Day 8. In addition, desquamation
(exfoliation) was seen in four males and four females from Days 5 to 9, resolving completely
in all animals by Day 11 and scabbing was noted in one female from Day 4 resolving
completely by Day 15.
Test substance staining was observed from Day 2 in four males, resolving in all animals by
Day 9.
Body weight:
One female was considered to have a low bodyweight gain during Days 1-8. All other
animals were considered to have satisfactory bodyweight gains throughout the study
Gross pathology:
A small stomach was noted in one female at the macroscopic examination on Day 15. No
macroscopic abnormality was noted in any other animal.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute median lethal dermal dose (LD50) to rats of Oxoil LS9 was demonstrated to be greater than 2000 mg/kg bodyweight.
Executive summary:

A study was performed at the Laboratories of Huntingdon Life Sciences, Alconbury, on behalf of Evonik Oxeno GmbH., to assess the acute dermal toxicity of the test substance Oxooil LS9. The study was conducted to GLP and in accordance with OECD Guideline 402 and EU Method B.3. The test substance was administered to the clipped dorsal skin of 5 male and 5 female rats at a dosage of 2000 mg/kg bodyweight under occlusive dressings for 24 hours (Limit test). Systemic and local signs of reaction to treatment were recorded at least once daily for 14 days following removal of the dressings.  There were no deaths and no systemic signs of reaction to treatment. Very slight or well-defined erythema, from Day 1 to 8, desquamation (exfoliation), from Day 5 to 9, and scabbing from Day 4 to 14, were observed amongst four male and four females rats. One female rat was considered to have low bodyweight gain during Days 1 to 8.

The acute dermal median lethal dosage (LD50) to rats of Oxooil LS9 was demonstrated to be greater than 2000 mg/kg bodyweight.

The study is considered acceptable for classification and satisfies the guideline requirements for a rat acute dermal toxicity test.