Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26th October to 9th November 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted in a GLP compliant laboratory according to accepted regulatory guidelines

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
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
semi-solid (amorphous): gel
Remarks:
migrated information: paste
Details on test material:
- Name of test material (as cited in study report): S-900
- Physical state: DARK BROWN PASTE
- Lot/batch No.: 02869
- Storage condition of test material: room temperature In the dark, handled under non-actinic lighting only
- Other:

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: REPUTABLE COMMERCIAL SUPPLIER
- Age at study initiation: 8-12 weeks
- Weight at study initiation:200-221g (males); 200-222g (femailes)
- Fasting period before study: No
- Housing: The animals were housed in suspended polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25C
- Humidity (%): 30-70%
- Air changes (per hr): Not stated
- Photoperiod (hrs dark / hrs light): Not stated

IN-LIFE DATES: From: To: 26th October to 9th November 1999

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: back and flanks
- % coverage:105 of total body surface area
- Type of wrap if used: A piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the 24-hour contact period the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with arachis oil BP to remove any residual test material
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Concentration (if solution):N/a
- Constant volume or concentration used: yes
- For solids, paste formed: yes test substance already a paste

Duration of exposure:
24 h
Doses:
2000 mg/kg/body weight
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 and weighing: The animals were observed for deaths or overt signs of toxicity Yz, 1,2 and 4 hours after dosing and subsequently once daily for fourteen days.
- Necropsy of survivors performed: no
- Other examinations performed: Gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormal ities was recorded. No tissues were retained.

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:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
No clinical signs of toxicity were noted during the study.

All animals showed an expected gain in bodyweight during the
study.
Body weight:
All animals showed an expected gain in bodyweight during the study.
Gross pathology:
Effects on organs:
No abnormalities were noted at necropsy.
Other findings:
Signs of toxicity (local):
Very slight to well defined erythema was noted at the
treatment sites of all animals one day after dosing and in
four female animals two and three days after dosing. Other
skin reactions noted at the treatment sites of all female
animals were haemorrhage of the dermal capillaries and crust
formation. The treatment sites appeared normal two to seven
days after dosing.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal median lethal dose (LD 5O) of the test material, S-900, in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.