Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010-04-28 to 2010-05-19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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)
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
Batch No.: 20091203
Purity: 99.42%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories Ltd, Oxfordshire, United Kingdom
- Age at study initiation: 8-12 wks
- Weight at study initiation: ≥ 200 g
- Fasting period before study:
- Housing: Individually during 24 hr exposure period; in groups of 4 for remainder of study
- Diet: Ad libitum, 2014 Teklad Global Rodent diet.
- Water: Ad libitum, mains water
- Acclimation period: ≥ 5 d

ENVIRONMENTAL CONDITIONS
- Temperature: 19 °C to 25 °C
- Humidity: 30 % to 70 %
- Air changes: ≥ 15 per hr
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- % coverage: Approx. 10 % of total body surface area
- Type of wrap if used: Surgical gauze held in place with semiocclusive self-adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: Wiped with cotton wool moistened with distilled water
- Time after start of exposure: 24 hrs

TEST MATERIAL
- Volume applied: 2.11 mL/kg bw
- Constant volume or concentration used: no
Duration of exposure:
24 hrs
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Preliminary study: 1 male, 1 female at 2000 mg/kg bw
Main study: 4 male, 4 female at 2000 mg/kg bw
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations at 30 min, 1, 2 and 4 hrs after dosing
- Necropsy of survivors was performed
- Other examinations performed: clinical signs, body weight, organ weights.

Results and discussion

Preliminary study:
Mortality 0/2 animals.
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There was no mortality during the observation period
Clinical signs:
There were no signs of systemic toxicity
Body weight:
All animals showed expected bodyweight gains during the study period. For full results please refer to attached supporting material.
Gross pathology:
No abnormalities were detected during necropsy.
Other findings:
- There were no signs of skin irritation or corrosion.

Applicant's summary and conclusion

Interpretation of results:
not classified
Conclusions:
The test substance was assessed for acute dermal toxicity according to OECD Guideline 402. The LD50 of the test material was >2000 mg/kg bw. The substance is therefore not classified.