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 test guideline 402 under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): C-SAT 100018
- Physical state: slightly yellowish solid
- Analytical purity: 100%
- Lot/batch No.: CF00460029
- Expiration date of the lot/batch: 29.02.2010
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH, 97633 Sulzfeld, Germany
- Weight at study initiation: 224 g — 255 g
- Housing: The rats were kept in transparent macrolone cages (type 3-180, floor area 810 sq.cm) with two or three in each cage, males and females separated. The cages were cleaned and the bedding changed at least twice a week.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: >= 5 days

ENVIRONMENTAL CONDITIONS
he study took place in animal room No. 4 provided with filtered air at a temperature of 22°C ± 3°C, relative humidity being at least 30 % and preferably not exceed 70 % and air changes 10 times/hour. The room was illuminated to give a cycle of 12 hours light and 12 hours darkness. Light was on from 6 am to 6 pm.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 6 x 8 cm
- Type of wrap if used: 4-layer gauze

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000mg/kg bw

Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
pilot study with one female rat using 2000 mg/kg bw

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
On day 0 after 1 hour, 3 hours and 6 hours the animal appeared apathetic. From day 1 to the end of the observation period on day 14 no abnormalities were revealed.
Body weight:
developed normally
Gross pathology:
The post mortem inspection revealed no pathological abnormalities.
Other findings:
No other findings, especially no sever skin reaction was observed.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a limit test study according to OECD test guideline 402 under GLP, the dermal LD50 of the test substance was determined to be > 2000 mg/kg bw.
Executive summary:

The acute dermal toxicity of the test substance was investigated in a study according to OECD test guideline 402 under GLP. Based on the results from a pilot study with one rat, a limit test with the concentration of 2000 mg/kg bw was performed with 5 male and 5 female Wistar rats. The rats were exposed for 24 hours, during which the test susbtance was occlusively applied without any vehicle. Up to 6 hours after application, the rate appeared apathetic. From day 1 to day 14 no mortality or clinical signs were observed. The body weight developed normally and no pathological abnormalities were found at the end of the study. Therefore, the test susbtance is considered to be practically nontoxic via the dermal route with an LD50 of larger than 2000 mg/kg bw.