Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
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 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes
Test type:
acute toxic class 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. 7 to 11 weeks
- Weight at study initiation: 156 - 196 g
- Fasting period before study: over-night prior to dosing
- Housing: three same-sex animals per cage
- 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

Route of administration:
oral: gavage
Vehicle:
other: 0.5% (w/v) carboxymethylcellulose in 0.1% (w/v) aqueous polysorbate 80
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2000 mg/10 mL
- Amount of vehicle (if gavage): 10 mL/kg

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: pre-test results
Doses:
2000 mg/kg
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days (or other?) 14 days
- Frequency of observations and weighing: observations: 1, 3, 5, 7 hours after dosing, daily from day 1 to day 14, weighing days 0, 7, and 14
- Necropsy of survivors performed: yes
- Other examinations performed: Clinical signs, body weight, necropsy
Statistics:
none

Results and discussion

Preliminary study:
not provided
Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There was no mortality in the study.
Clinical signs:
There were no in-life observations indicating treatment-related systemic effects on any males.
Slight reduced activity was observed in all females on the treatment day which lasted in once female (no. 101) through day 1, and in one female (no. 102) through day 2, slightly hunched posture in two females (no 101 and 103) on the treatment day through day 1, and in one female (no. 102) on the treatment day through day 4, slight piloerection in all females on the treatment day, which lasted in one female (no. 102) through day 2. In addition, skin cold to touch, recumbency, and slight dyspnea were seen in one female (no. 102) on days 1 and 2. All females appeared normal on day 5 after treatment.
Body weight:
A severe loss of body weight was recorded in one female (no. 32) during the first week after treatment.
Gross pathology:
Necropsy examinations revealed no observable abnormalities.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 > 2000 mg/kg
Executive summary:

The acute oral toxicity (gavage) of ITTFEP (purity 82.3%) 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 toxicity testing in 3 male and 3 female rats showed that the LD50 of the test item was > 2000mg/kg body weight. No mortalities were observed. The body weight evolution was not influenced during the 14-day observation period.

There were no in-life observations indicating treatment-related systemic effects on any males. Slight reduced activity was observed in all females on the treatment day which lasted in once female (no. 101) through day 1, and in one female (no. 102) through day 2, slightly hunched posture in two females (no 101 and 103) on the treatment day through day 1, and in one female (no. 102) on the treatment day through day 4, slight piloerection in all females on the treatment day, which lasted in one female (no. 102) through day 2. In addition, skin cold to touch, recumbency, and slight dyspnea were seen in one female (no. 102) on days 1 and 2. All females appeared normal on day 5 after treatment.

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