Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study according to OECD guideline 402 under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: solid
- Analytical purity: >99%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd, Biotechnology & Animal Breeding Division, Wölferstrasse 4, CH-4414 Füllinsdorf, Switzerland
- Age at study initiation: 9 weeks for males and 12 weeks for femals
- Weight at study initiation: males 224.3 - 238.5 g, females 197.1 - 217.9 g
- Housing: Groups of 5 in Makrolon type-4 cages with standard softwood bedding, during treatment and observation individually in Makrolon type-3 cages with standard softwood bedding
- Diet (e.g. ad libitum): Pelleted standard Kliba 3433 rat maintencance diet, available ad libitum
- Water (e.g. ad libitum): Community tap water from itingen, available ad libitum.
- Acclimation period: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 40 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12, recorded music was played for approx. 8 hours during the light period

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Approx. 10% of total body surface
- Type of wrap if used: semi occlusive dressing, wrapped around the abdomen and fixed with an elastic adhesive bandage


REMOVAL OF TEST SUBSTANCE
- Washing (if done): flushed with lukewarm tap water and dried with disposable paper towels
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 6.0 ml / kg bw
- Concentration (if solution): 2000 mg/kg bw
- Constant volume or concentration used: yes
- For solids, paste formed: no
Duration of exposure:
24h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Male: Number of animals: 5
Female: Number of animals: 5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Mortality/Viability: Four times during test day 1 (day of administration) and once daily during days 2 to 15
- Body weights: on test day 1 (pre-administration), days 8 and 15
- Clinical sign: Each animal was examined for changes in appearance and behaviour four times during day 1 (day of administration), and once daily during days 2 to 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology
Statistics:
Not applicable. No statistical analysis was used as no deaths occured

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No deaths occured during the study
Clinical signs:
No systemic or local signs of toxicity were observed during the study period
Body weight:
The body weight of the animals was within the range commonly recorded for animals of this strain and age
Gross pathology:
No macroscopic findings were observed at necropsy

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
As no mortality occured in the acute dermal toxicity test (OECD 402), the LD50 of the test item is > 2000 mg/kg boddyweight. Based on these results and according to the EC criteria for classification and labelling according to DSD (Directive 67/548/EEC) or GHS/CLP (Regulation (EC) No. 1272/2008), the test item does not have to be classified and has no obligatory labelling requirement for oral toxicity.
Executive summary:

As no mortality occured in the acute dermal toxicity test (OECD 402), the LD50 of the test item is > 2000 mg/kg boddyweight and therefore the substance is not classified.