Reaction mass of chlorodifluoroacetic acid and trifluoroacetic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

from 03 jan 1990 to 23 aug 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study, OECD 401 compliant

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

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Chlorodifluoroacetic acid

EC Number:

200-928-8

EC Name:

Chlorodifluoroacetic acid

Cas Number:

76-04-0

Molecular formula:

C2HClF2O2

IUPAC Name:

chloro(difluoro)acetic acid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Iffa-Crédo (69592 L'Arbresle, France)
- Age at study initiation: 5 to 7 weeks old
- Weight at study initiation: 127 to 173 g
- Housing: 5 par sex and per group, in polycarbonte cages, type MI (365x225x180 mm)
- Diet (e.g. ad libitum): ad libitum, rat-mice pellets (U.A.R, formule A.04 - U.A.R Villemoison, 91360 Epinay/Orge, France)
- Water (e.g. ad libitum): softened and filtered water (0.6µm), ad libitum
- Acclimation period: 10 days before

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 10 minimum
- Photoperiod (hrs dark / hrs light): 12h/12h

IN-LIFE DATES: not indicated

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 0.066 mL/kg

Doses:

0, 26, 56, 75 and 101 mg/kg

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing: the day before treatment, just before administration, Day 8 and Day 15, or just after death.
Clinical signs and mortality: 1/4 hour, 1 hour, 2 hours and 4 hours after gavage, then daily up to day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
Clinical signs: breathing, piloerection, central nervous system, tremor, salivation . . .

In a preliminary test, the product was tested at the following doses: 62.7, 125.5, 250.9 and 500.3 mg/kg. There was 100% of mortality at 125.5, 250.9 and 500.3 mg/kg and 75% at 62.7 mg/kg.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 26 - < 56.6 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Lethality was caused by local corrosive effects.

Mortality:

10% at 26 mg/kg, 80% at 56.6 mg/kg, 90% at 75 mg/kg and 100% at 101 mg/kg.

Clinical signs:

other: At 26 mg/kg: no clinical signs observed. At 56.6 mg/kg: roaring breathing, piloerection, ataxia. Nomore clinical signs after 7 or 8 days in the survivals. there 3/5 deaths in males and 5/5 deaths in females. At 75 mg/kg: ataxia in all animals, with roarin

Gross pathology:

Oesophagus perforation, stomach ulcer (at the highest dose), congestive areas in lungs.

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category II

Conclusions:

Chlorodifluoroacetic acid is fatal if swallowed according to CLP 1272/2008.

Executive summary:

In a GLP study, Chlorodifluoroacetic acid was tested to evaluate the acute toxicity following a single oral adminitration at doses from 0, 26, 56.6, 75 and 101 mg/kg bw undiluted.

There were 0, 10 80, 90 and 100% of mortality respectivley so the LD50 by oral route is between 26 and 56.1 mg/kg bw.

Macroscopic examination observation showed that mortality is related to strong corrosivity of CDFA and thus to local effects instead of actual systemic effects.

In these conditions, Chlorodifluoroacetic acid is considered fatal by ingestion according to CLP 1272/2008.