Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27 November 2008 - 11 December 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

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 (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Details on test material:
- Physical state: tan colored solid
- Storage condition of test material: room temperature in the dark
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: Recieved from sponsor 23 June 2008

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: >200g
- Housing: Individually during the 24 hour exposur eperiod and in groups of 5 for the observation period. The animals were housed in solid floor suspended polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: >5 days
- Method of randomisation in assigning animals to test and control groups : On receipt the animals were randomly allocated into cages, After acclimisation, the animals were selected at random and given a numbe runique within the study by inedible ink marking on the tail and on the cage card

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

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
arachis oil
Details on dermal exposure:
TEST SITE
- Area of exposure:
- % coverage: 10% of body surface area
- Type of wrap if used: Surgical guaze semi-occluded with a self adhesive bandage

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

TEST MATERIAL
- Concentration (if solution): 2000 mg/kg
- Constant volume or concentration used: yes
Duration of exposure:
24 hours
Doses:
- 2000 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female
Control animals:
not required

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
There were no deaths
Clinical signs:
There were no signs of systemic toxicity
Body weight:
Animals showed expected gains in bodyweight over the study period, except for two females which showed bodyweight loss or no gain in bodyweight during the first week but expected gain in bodyweight during the second week
Gross pathology:
No abnormalities were noted at necropsy.

Any other information on results incl. tables

The acute dermal median lethal dose (LD50)of the test material in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.

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 Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.
Executive summary:

The study was performed to assess the acutedermal toxicity of the testmaterial in the Wistar strain rat according to OECD Guideline 402 and Method B3 Acute Toxicity (Dermal) of Commission Directive 92/69/EEC. A group of ten animals(fivemales and five females) was given a single, 24-hour, semi-occluded dermal application of the test material to intact skin at a dose level of 2000 mglkg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy. There were no deaths,no signs of systemic toxicity, andno signs of dermal irritation. Animals showed expected gains in body weight over the study period, except for two females which showed body weight loss or no gain in body weight during the first week but expected gain in body weight during the second week. No abnormalities were noted at necropsy. The acutedermal median lethal dose (LD50)of the test material in theWistar strain rat was found to be greater than 2000 mg/kg bodyweight.