2,5-Dichloro-4-(1,1,2,3,3,3-hexafluoropropoxy)phenylamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Test article: CGA 224443 tech.
- Batch No.: P.810012
- Purity: 92,6 %

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ciba-Geigy Ltd.
- Age at study initiation: 6 - 8 weeks
- Weight at study initiation: 171 - 221 g
- Housing: Macrolon cages type 4, soft wood bedding
- Diet (e.g. ad libitum): NAFAG 890 Tox, and water
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 10
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

DESIGN AND PROCEDURE

- Administration of the test article: one single oral dose, by gastric intubation (gavage)
- Dose levels, sex group: 200 mg/kg females; 1000 mg/kg males and females; 2000 mg/kg females
- Total number of animals: 20
- Vehicle: Oil arachidis Ph.H.VI (Siegfried AG, Switzerland)
- Volume applied: 10 ml/kg body weight
- Observation period: 14 days

Doses:

200 mg/kg females
1000 mg/kg males and females
2000 mg/kg females

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

OBSERVATIONS AND RECORDS
- Observation period: 14 days
- Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days
- Signs and symptoms: daily
- Body weight: immediately before administration and on days 7 and 14, and at death
- Necropsies: Spontaneously dying animals were submitted to a gross necropsy as soon as possible; survivors at the end of the observation period.

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 1 000 mg/kg bw

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

1 174 mg/kg bw

Effect levels 3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 273 mg/kg bw

Mortality:

see attached Table 1

Clinical signs:

Piloerection, hunched posture, exophthalmos and dyspnea were seen, being common symptoms in acute tests.
Additionally, reduced locomotor activity and cyanose was observed in the males dosed with 1000 and 2000 mg/kg, respectively. All females of the 2000 and one female of the 1000 mg/kg experienced ataxia, the former group died two days after administration. In one male dosed with 1000 mg/kg respiratory sounds were recorded, two died within four days after administration.
The surviving animals recoverd within 5 to 7 days.
See attached Table 3

Body weight:

see attached Table 2