Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 5, 2000 - April 19, 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted under GLP conditions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

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

Test material

Constituent 1
Reference substance name:
T-7145
IUPAC Name:
T-7145
Details on test material:
- Name of test material (as cited in study report: T-7145
- Physical state: Clear, colourless liquid
- Analytical purity: >99.5%
- Lot/batch no.: Lot 4
- Specific activity (if radiolabelling): 1.61

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: Approx. 8 weeks
- Weight at study initiation: 289 g for males; 212 g for females
- Fasting period before study: no
- Housing:- Diet (e.g. ad libitum): Indiviiduall housed with purified saw dust as bedding. Diet: Ad libitum to standard pelleted lab animal diet
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 degrees C
- Humidity (%): 30-70%
- Air changes (per hr) 15:
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
IN-LIFE DATES: From: 5 April 2000 To: 19 April 2000

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 25 cm2 for males and 18 cm2 for females
- % coverage: 10%
- Type of wrap if used: Surgical gauze covered with aluminum foil and Coban flexible bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.24 ml/kg body wt
Duration of exposure:
24h
Doses:
1
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Dail observation. Animals were weighted on days 1, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights,macroscopic examination
Statistics:
No

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: Duration : 24h
Mortality:
No mortality
Clinical signs:
None
Body weight:
Weight gain was within the expected range
Gross pathology:
No abnormalities observed

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Practically non-toxic LD50> 2000 mg/kg bw
Executive summary:

CAS 297730-93-9 was administered to 5 male and 5 female Wistar rats by dermal application with an occlusive dressing at 2000 mg/kg.bw for 24 hours. Animals were observed daily and body weights were determined weekly. Macroscopic examination was performed after terminal sacrifice at day 15.

No mortality occurred. No clinical symptoms or abnormalities at post mortem were noted. Mean body weight gain during the observation period was within the range expected for rats used in this type of study.

The Dermal LD50 is greater than 2000 mg/kg bw.

CAS 297730-93-9 does not have to be classified and has no obligatory labelling requirement for dermal toxicity.