Sodium chloroacetate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 January 1988 to 11 February 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium chloroacetate

EC Number:

223-498-3

EC Name:

Sodium chloroacetate

Cas Number:

3926-62-3

Molecular formula:

C2H2ClNaO2

IUPAC Name:

sodium chloroacetate

Details on test material:

- Name of test material (as cited in study report): Natriummonochloroacetat
- Substance type: white powder
- Physical state: solid
- Analytical purity: 96.2 % (w/w)
- Composition of test material, percentage of components:
Sodiumdichloroacetate: 0.35% (w/w)
water: 0.52 % (w/w)
sodiumchloride: 0.65 % (w/w)
sodium glycolate: 0.91 % (w/w)
Lead: ca. 1 mg/kg
monochloroacetic acid: 1.45% (w/w)
sodiumcarbonate: 1.48% (w/w)
Iron: 2.70 mg/kg
- Purity test date: not specified
- Lot/batch No.: 6879
- Expiration date of the lot/batch: not specified
- Stability under test conditions: not specified
- Storage condition of test material: in the dark at 22 degrees Censius

Test animals

Species:

rat

Strain:

other: Wistar Hoe: WISKf(SPF71)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechsty AG.
- Age at study initiation: males: approx. 7 weeks. Females: approx. 8 weeks
- Weight at study initiation: males: mean 213 grams (190-229 grams), females mean 209 grams (203-215 grams)
- Fasting period before study: no
- Housing: Individual housing in Macrolon Type 3 cages containing sawdust.
- Diet (e.g. ad libitum): ad libitum (Altromin 1324)
- Water (e.g. ad libitum): ad libitum ( tapwater)
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 degrees Celcius
- Humidity (%): 50 +/- 20%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 21 January 1988 to 11 February 1988

Administration / exposure

Type of coverage:

occlusive

Vehicle:

physiological saline

Remarks:

ratio: 1.0 gram test substance + 0.36 ml vehicle

Details on dermal exposure:

TEST SITE
- Area of exposure: It was reported that a skin area op approx. 30 square cm was shaved, and a patch of 48 square cm was applied. This will likely have been incorrectly reported, i.e. the skin area shaved should likely read 48 square cm and the patch are should likely read 30 square cm.
- % coverage: not specified but considered to exceed 10% of body surface based on area of exposure and weight of rats.
- Type of wrap if used: elastic bandage, 8 cm wide.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with tepid tapwater
- Time after start of exposure: after removal of the bandage.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1600, 2000 or 2500 mg test substance moistened in ratio 1.0 grams test substance with 0.36 mL physiological saline.
- Constant volume or concentration used: constant concentration.
- For solids, paste formed: yes: 1.0 grams test substance with 0.36 mL physiological saline.

Duration of exposure:

24 hours

Doses:

Males: 1600, 2000 and 2500 mg/kg
Females: 2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations: 10 and 30 minutes and 1, 2, 4 and 6 hours after application, and daily after removal of bandage up to 14 days after exposure.
Body weights: weekly
- Necropsy of survivors performed: yes

Statistics:

LD50 value was calculated using Probitanalysis.

Results and discussion

Preliminary study:

Not applicable.

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

3 250 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Males:
1600 mg/kg: 0/5
2000 mg/kg: 2/5
2500 mg/kg: 1/5

Females:
2000 mg/kg: 0/5

Clinical signs:

other: Day of application: no clinical signs. Between Days 1 and 4 after application: hunched posture, subdued flanks, reduced activity, diarrhoea, uncoordinated movements, irregular breathing, rales Between Days 1-6 after application: Patchy erythema of treate

Gross pathology:

Non-surviving animals: pale spleen and liver, accentuated lobular pattern of the liver, and/or swollen urinary bladder.
Surviving animals: no abnormalities.

Other findings:

None.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 males: 3250 mg/kg
LD50 females >2000 mg/kg