Triclosan

Acute Toxicity: oral

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPP 81-1 (Acute Oral Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Triclosan

EC Number:

222-182-2

EC Name:

Triclosan

Cas Number:

3380-34-5

Molecular formula:

C12H7Cl3O2

IUPAC Name:

5-chloro-2-(2,4-dichlorophenoxy)phenol

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 or test system 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:

other: 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 dischar

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.