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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002-06-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
(adopted 24 February 1987)
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes (incl. certificate)
Remarks:
Safepharm Laboratories Limited P.O. Box No. 45 DERBY DEI2BT U.K.
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- State of aggregation: liquid
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, in the dark

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: approximately eight weeks
- Weight at study initiation: at least 200 g
- Fasting period before study: no
- Housing: in cages finnished with woodflakes. The animals were housed individually during the 24-hour exposure period and in groups of five, by
sex, for the remainder of the study.
- Diet: Certified Rat and Mouse Diet (Code 5LF2) supplied by PMI Nutrition International, ad libitum
- Water:ad libitum
- Acclimation period: at least five days

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

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: back and flanks
- % coverage: approximately 10% of the total body surface area
- Type of wrap if used: surgical gauze semi-occluded with a piece of self-adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with cotton wool moistened with distilled water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.64 mL/kg
- Concentration (if solution): 100%
- Constant volume or concentration used: yes
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days, body weights: Day 0 and on Days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, behavioural observation

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths.
Clinical signs:
There were no signs of systemic toxicity. There were no signs of dermal irritation.
Body weight:
No toxicologically significant effects on bodyweight were noted over the study period.
Gross pathology:
No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD (Cri:CD® (SD) IGS BR) strain rat was found to be greater than 2000 mg/kg bodyweight.
Executive summary:

A GLP compliant study according to the OECD guideline 402 and according to Method B3 of the Commission Directive 92/69/EEC was performed to assess the acute dermal toxicity of the test material in the Sprague-Dawley CD (Cri: CD® (SD) IGS BR) strain rat. A group of ten animals (five males and five females) was treated with a single, 24-hour, semi-occluded dermal application of undiluted test material to the intact skin at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subject to gross necropsy. There were no deaths and no signs of systemic toxicity. There were no signs of dermal irritation. No toxicologically significant effects on bodyweight were noted over the study period. No abnormalities were noted at necropsy. In conclusion, the acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD (Cri: CD® (SD) IGS BR) strain rat was found to be greater than 2000 mg/kg bodyweight.