Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline and GLP compliant study with good documentation.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Hanlbm: WIST (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd.; biotechnology & Animal Breeding Division; 4414 Füllingsdorf; Switzerland
- Age at study initiation: approx. 8 to 12 weeks
- Weight at study initiation: 204 - 243 g
- Housing: individual
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days prior to treatment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50% +/- 20%
- Air changes (per hr): 13-14/hour
- Photoperiod (hrs dark / hrs light): 12/12 hours

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: 0.5% (w/v) carboxymethylcellulose in 0.1% (w/v) aqueous polysorbate 80
Details on dermal exposure:
TEST SITE
- Area of exposure: about 6x4 cm
- % coverage: approx. 8% of body surface
- Type of wrap if used: Gauze patches (6x4 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm water
- Time after start of exposure :after 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 400 mg application suspension/100 g body weight (200 mg a.i./100 g bw)
- Concentration (if solution): Diluted 50:50 with the vehicle
- Constant volume or concentration used: yes
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): 200 mg/100 g bw
- Concentration (if solution): 0.5% (w/v) carboxymethylcellulose in 0.1% (w/v) aqueous polysorbate 80
Duration of exposure:
24 h
Doses:
2000 mg / kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: before application and on days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
none

Results and discussion

Preliminary study:
not reported
Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 1 828 mg/kg bw
Based on:
act. ingr.
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 1 828 mg/kg bw
Based on:
act. ingr.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
There were no remarkable clinical observations for any animal.
Body weight:
There were no effects on body weight development in males. A slight loss of body weight was recorded in one female during the first week after treatment and in one female during the second week after treatment.
Gross pathology:
Necropsy examinations revealed no observable abnormalities.
Other findings:
There were no remarkable findings for local tolerance for any animal.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

The acute dermal toxicity of CTFEP (purity 91.4%) to rat was determined in a GLP compliant test according to OECD 423 (Sommer 2000). Since the study was performed under GLP and according the guideline and based on the good documentation the study was awarded with Klimisch 1. The acute dermal toxicity testing in 5 male and 5 female rats showed that the LD50 of the test item (containing 91.4 % CTFEP) was > 2000mg/kg body weight. No mortality was observed. There were no remarkable clinical observations for any animal. There were no effects on body weight development in males. A slight loss of body weight was recorded in one female during the first week after treatment and in one female during the second week after treatment. Necropsy examinations revealed no observable abnormalities. There were no remarkable findings for local tolerance for any animal.

The obtained results are considered as relevant for the risk assessment.