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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:
From 12 AUG 2004 to 2 SEP 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guidelinie study (OECD TG 402)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

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
GLP compliance:
yes (incl. certificate)
Remarks:
in compliance with the Swiss Ordinance relating to GLP [RS 813.016.5]
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
rat
Strain:
other: HanBrl : Wist (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services, Füllinsdorf, Switzerland
- Age at study initiation: males: 9 weeks; females: 12 weeks
- Fasting period before study: 19 to 20 h
- Housing: Macrolon cages (type 4) in groups of five per sex
- Diet: peletted standard Provimi Kliba 3433 rat/mouse maintenance diet (Provimi Kliba AG, Kaiseraugst, Switzerland); ad libitum
- Water: tap water; ad libitum
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3
- Humidity (%): between 30 to 70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
corn oil
Details on dermal exposure:
TEST SITE
- Area of exposure: backs of the animals 10% of total body surface was clipped one day before treatment)
- Type of wrap if used: gauze patch with semiocclusive dressing, fixed with elastic adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the dressing was removed and the skin was flushed with lukewarm tap water
- Time after start of exposure: 24 after application


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): 0.25 g/mL
- Application volume/kg bw: 8 mL
- Application: test material was put on the gauze patch with a syringe, then the gauze patch was applied on the intact skin
Duration of exposure:
24
Doses:
2000 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: at least daily
- Frequency of weighing: weekly
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: no animals died within the 14 day observation period
Mortality:
- no deaths occured
Clinical signs:
- no systemic signs of toxicity were observed
- Marked pink staining of the skin (grade 3 of 3) caused by the test item was noted in all animals on test day 2. The staining persisted at slight degree (grade 1 of 3) in males up to test days 10 (two cases) test days 11, 14 or 15 and in all females up to test day 15 which marked the end of the observation period.
Body weight:
- body weight development was not impaired
Gross pathology:
- all animals killed at the end of the observation period showed no macroscopically visible changes

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP regulation
Conclusions:
Single application of the limit dose of 2000 mg test substance per kg bw onto the skin did not cause lethality in male and female HanBrl: Wist rats during the 14 day observation period, resulting in a LD50 > 2000 mg/kg bw.
Executive summary:

Male and female rats were subjected to test acute dermal toxicity (OECD TG 402, Limit test). The test substance was administered on the skin in a suspension at the limit dose of 2000 mg/kg bw to 5 male and 5 female rats. No animal died within the observation period, resulting in a LD50 > 2000mg/kg bw.

Classification for acute oral toxicity is not necessary according to Regulation (EC) No 1272/2008.