Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1999/05/12-1999/05/26
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
other company data
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
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS

- Source: Charles River Deutschland, Germany

- Age at study initiation: approximately 9 weeks

- Weight at study initiation: 241g females, 356g males

- Housing: Individually housed in labelled polycarbonate cages containing purified sawdust as bedding material

- Diet: standard pelleted laboratory animal diet, ad libitum

- Water: tap water, ad libitum

- Acclimation period: Minimum of 5 days


ENVIRONMENTAL CONDITIONS

- Temperature (°C): 21C

- Humidity (%): 50

- Air changes (per hr): ca.15

- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE

- Area of exposure: dorsal skin

- % coverage: 10%

- Type of wrap if used: The test substance was held in contact with the skin with a dressing, consisting of a surgical gauze patch, succesively covered with aluminium foil and Coban flexible bandage. A piece of Micropore tape was additionally used for fixation of the bandages in females only.


REMOVAL OF TEST SUBSTANCE

- Washing (if done): The dressings were removed and the skin cleaned of residual test substance using water

- Time after start of exposure: 24h


TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 2.22 ml/kg
Duration of exposure:
Single instillation, washed after 24 hours.
Doses:
2000 mg/kg
No. of animals per sex per dose:
5M, 5F
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing:The animals were observed for mortality/viability twice daily. The body weights were recorded on day 1 (pre-administration), 8 and 15.

- Necropsy of survivors performed: yes

- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Clinical signs were recorded at periodic intervals on the day of dosing (day 1) and once daily thereafter, until day 15. The time of onset, degree and duration were recorded and the symptoms graded according to fixed scales. Descriptions of all internal macroscopic abnormalities were recorded at necropsy.
Statistics:
No statistical analysis was reported.

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 mortality occurred.
Clinical signs:
No clinical signs were seen in any of the animals.
Body weight:
The changes noted in body weight gain in males and females were within the range expected for rats used in this type of study and were therefore considered not indicative of toxicity.
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.
Other findings:
None reported.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 value of >2000mg/kg was determined in a reliable study conducted according to an appropriate test protocol and in compliance with GLP.