Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EPA OPP 81-1 (Acute Oral Toxicity)
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Triclosan
- Physical state: white crystalline powder
- Analytical purity: 99.7%
- Lot/batch No.: #5.2.0211.0
- Stability under test conditions: stable at room temperature for 5 years
- Storage condition of test material: at room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hilltop Lab Animals, Scottdale, PA
- Age at study initiation: young adult animals were used
- Weight at study initiation: males 181-197 g, females 194-216 g
- Fasting period before study: twenty hours prior testing
- Housing: singly, in suspended stainless steel cages
- Diet (e.g. ad libitum): Purina Rodent Chow #5012, ad libitum
- Water (e.g. ad libitum): filtered tap water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Photoperiod (hrs dark / hrs light): 12 hrs/12 hrs

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
The test compound was administered as a 30% w/w suspension in a 2.5% w/w suspension of carboxymethylcellulose in distilled water.
Individual doses were calculated based on the initial body weights, taking into account the specific gravity and concentration of the test suspension.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
Five animals per sex
Control animals:
no
Details on study design:
After treatment, the animals were observed for signs of gross toxicity and mortality at least once daily for 14 days.
Body weights were recorded just prior to administration, on Day 7 and 14 (termination) or after death.
Necropsies were performed on all animals.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
One female died on day 3 of the study.
Clinical signs:
All animals exhibited clinical signs including diarrhoea, soft faeces, ano-genital staining, and hunched posture, lethargy, abdominal distension, piloerection, ocular discharge and/or irregular respiration.
Apart from one male exhibiting ocular discharge and chemosis through test termination, all survivors recovered from the above clinical signs by day 7.
Body weight:
All animals gained weight over the 14-day observation period.
Gross pathology:
Gross necropsy of the decedent revealed discoloration of the lungs and gastro-intestinal tract and injection of the blood vessels of the gastro-intestinal tract.
Gross necropsy findings at terminal sacrifice were generally unremarkable.

Applicant's summary and conclusion