Registration Dossier

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:
other: None.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Principles of method if other than guideline:
None.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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 levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
3 250 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 95% confidence interval not clear from presented data
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:
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 treated skin, swelling, dryness, scaliness and/or scabs of the treated skin.
Body weight:
No relevant changes.
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.

Any other information on results incl. tables

None.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 males: 3250 mg/kg
LD50 females >2000 mg/kg