Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
4/6/2008-14/08/2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
According to the OECD Guideline and in compliance with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Physical state: liquid
- Stability under test conditions: under storage conditions
- Storage condition of test material: at room temperature (20±5°C), light protected
- Expiry date: 10-APR-2009
- Stability of Test Item Dilution: Stable for 7 days in water

Test animals

Species:
rat
Strain:
Wistar
Remarks:
HanRcc:WIST (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd
- Age at study initiation: male: 9 weeks; female: 11 weeks
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, ad libitum
- Water (e.g. ad libitum): Community tap water, ad libitum
- Housing: groups of five per sex in Makrolon type-4 cages with standard sotwood bedding during acclimatisation ; then individually in Makrolon type-3 cages with standard softwood bedding during treatment and observation period.
- Acclimation period: not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Remarks:
purified water
Details on dermal exposure:
TEST SITE
- % coverage: 10

TEST MATERIAL
- Concentration (if solution): 0.5g /mL
- Volume dosage: 4 mL / kg bw
Duration of exposure:
The application period was 24 hours.
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 males
5 females
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1, and twice daily during days 2-15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, local signs, body weight, macroscopic examinations at necropsy.
Statistics:
No statistical analysis was used.

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:
No deaths ocurred during the study
Clinical signs:
No clinical signs were during the course of the study.
A moderate erythema was noted in all animals on test day 2 and persisted as slight up to test days 9 or 10. Slight to moderate scaling was observed in all animals from test days 3 or 6 to up to test days 10 or 15. Slight crusts were noted in two males on test days 6 to 10. slight oedema was noted in all females on test days 3 to 5.
Body weight:
One female lost weight during the first week after treatment (body weight loss 2.7%) but it recovered until the end of the study. Otherwise, the body weight of the animals was within the range commonly recorded for this strain and age.
Gross pathology:
No macroscopic finding were observed at necropsy

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the dermal LD50 for the registered substance is higher than 2000 mg/kg bw in rats therefore it is not classified according to the Annex I of the Regulation EC No. 1272/2008 (CLP) and to the GHS.
Executive summary:

In an acute dermal toxicity study (limit test) performed according to the OECD test guideline No. 402 and in compliance with GLP, five male and five female rats were treated with the substance at 2000 mg/kg by dermal application. The test item was diluted in vehicle (purified water) at a concentration of 0.5g/mL and administered at a volume dosage of 4mL/kg. The test site was covered with a semi-occlusive dressing for 24 hours. Animals were observed for mortality, clinical signs, local signs and body weights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination.

No clinical signs were observed throught the duration of the study. A moderate erythema was noted in all animals on test day 2 and persisted as slight up to test days 9 or 10. Slight to moderate scaling was observed in all animals from test days 3 or 6 to up to test days 10 or 15. Slight crusts were noted in two males on test days 6 to 10. Slight oedema was noted in all females on test days 3 to 5. No abnormalities were detected at necropsy.

Bodyweights were within the range commonly recorded for this strain and age. No abnormalities were noted at necropsy.

Dermal LD50 Combined > 2000 mg / kg bw

Under the test conditions, the dermal LD50 for the registered substance is higher than 2000 mg/kg bw in rats therefore it is not classified according to the Annex I of the Regulation EC No. 1272/2008 (CLP) and to the GHS.

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